Bone Metastases, Castration-Resistant Prostate Cancer
Conditions
Keywords
The target population is patients with bone metastasis from castration-resistant prostate cancer intended for treatment with docetaxel
Brief summary
The main purpose of this study is to establish a recommended dose of Alpharadin to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.
Detailed description
The trial was initially conducted and submitted by Algeta ASA. After acquiring Algeta, Bayer is now the sponsor.
Interventions
DRUGRadium-223 dichloride (Xofigo, BAY88-8223)
Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection.
DRUGDocetaxel
Docetaxel (75 mg/m\^2) will be administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. Step-down to 60 mg/m\^2 is allowed as per the approved docetaxel label.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the prostate. * Two or more bone metastases (hot spots) confirmed by bone scintigraphy within 8 weeks prior to study entry * Known castration-resistant disease * Karnofsky Performance Status (KPS): ≥70% within 14 days before start of study treatment (ECOG 1) * Life expectancy at least 6 months. * Acceptable hematology and serum biochemistry screening values * Eligible for use of docetaxel according to the product information (package insert or similar).
Exclusion criteria
* Has received an investigational therapeutic drug within the last 4 weeks prior to start of study treatment, or is scheduled to receive one during the treatment period. * Has received external radiotherapy within the last 4 weeks prior to start of study treatment. * Has an immediate need for radiotherapy. * Has received prior hemibody external radiotherapy . * Has received systemic radiotherapy (e.g. samarium, strontium etc.) for the treatment of bone metastases. * Has received cytotoxic chemotherapy within the last 4 weeks prior to start of study treatment, or has not recovered to grade 1 or 0 from adverse events due to cytotoxic chemotherapy administered more than 4 weeks earlier. * Has received more than ten previous infusions of docetaxel. * Previous known experience of grade ≥ 3 docetaxel related toxicities or docetaxel toxicity related dose interruption or discontinuation. * Previous use of G-CSF for persistent neutropenia after docetaxel treatment. * Has received blood transfusion or erythropoietin (EPO) within the last 4 weeks prior to start of study treatment. * Has received prior treatment with Alpharadin. * Malignant lymphadenopathy exceeding 3 cm in short-axis diameter. * Symptomatic nodal disease, i.e. scrotal, penile or leg edema. * Visceral metastases from CRPC (\>2 lung and/or liver metastases \[size ≥2cm\]), as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to start of study treatment. * Uncontrolled loco-regional disease. * Other primary tumor (other than CRPC) including haematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer). * Has imminent or established spinal cord compression based on clinical findings and/or MRI. * Unmanageable fecal incontinence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Signs of Long-Term Radiation Toxicity | From start of study treatment upto 12 months | Long-term radiation toxicity included incidence of potential late toxicity, such as new primary cancers and bone marrow changes (acute myelogenous leukemia, myelodysplastic syndrome, and aplastic anemia). |
| Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort) | In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. |
| Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort) | In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. |
| Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort) | In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. |
| Changes From Baseline in Respiratory Rate During the Treatment Period | From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort) | In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. |
| Changes From Baseline in Heart Rate During the Treatment Period | From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort) | In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. |
| Changes From Baseline in Weight During the Treatment Period | From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort) | In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. |
| Number of Subjects With Physical Examination During the Treatment Period | From start of study treatment to 6 weeks after study treatment (i.e., maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort) | Any physical examination finding that was classified by the investigator as a clinically significant change (compared with previous examination) was considered an AE, documented on the eCRF, and followed until the outcome was known. The below physical examination findings were recorded and reported. GDASC = General disorders and administration site conditions MND = Metabolism and nutrition disorders SSTD= Skin and subcutaneous tissue disorders MCTD = Musculoskeletal and connective tissue disorders IPPC = Injury, poisoning and procedural complications RTMD = Respiratory, thoracic and mediastinal disorders NBMU = Neoplasms benign, malignant and unspecified (include cysts and polyps) In the below table. |
| Number of Subjects With Dose-Limiting Toxicities - Dose Escalation Part | From randomization until 6 weeks post-injection in all dose cohort of dose-escalation part | DLT was defined as - Absolute neutrophil count grade greater than or equal to (\>=) 4 (Common Terminology Criteria for Adverse Events \[CTCAE\], Version 4.0: less than \[\<\] 0.5 × 109 per Liter) lasting longer than 7 days without fever despite granulocyte colony-stimulating factor (G-CSF) support). Platelet count Grade \>= 4 (CTCAE, v4.0: \< 25× 109/L) lasting longer than 7 days. Diarrhea Grade \>= 3 (CTAE, v4.0: increase of \>= 7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared with baseline; limiting self-care in activities of daily living) in spite of optimal use of antidiarrheal medication. Vomiting or constipation Grade \>= 4 (CTCAE, v4.0: life-threatening consequences; urgent intervention indicated). Febrile neutropenia Grade \>= 3 (CTCAE, v4.0). |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | From start of study treatment to 6 weeks after study treatment (that is maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort) and 8 weeks for serious AEs | Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in patient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment. |
| Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort) | In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. |
| Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort) | In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. |
| Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort) | In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. |
| Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort) | In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers | From start of study treatment to 6 weeks after study treatment (maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort) | Weighted mean area under the curve for the below bone turnover biomarkers were evaluated, ICTP = pyridinoline cross-linked carboxyterminal telopeptide P1NP = N-terminal peptide of procollagen type 1 uCTX-1 = urine C-telopeptide 1 |
| Exploratory Efficacy: Time to Prostate-specific Antigen (PSA) Progression | 12 months | Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least 1 week apart. |
| Exploratory Efficacy: Time to Clinical or Radiographic Progression | From start of study treatment to 12 months, at every 12 weeks | Time to first radiologic or clinical progression is determined by one of the following: * For soft tissue lesions, the determination is based on Response Evaluation Criteria in Solid Tumors 1.1. * For bone disease, the determination is based on Prostate Cancer Working Cohort 2 (PCWG2) definitions, which require the appearance of at least 2 new lesions with a confirmatory bone scan at least 6 or more weeks later. For clinical progression, the investigators followed the recommendations of the PCWG25 and used their clinical judgment to determine clinical progression. |
| Progression Free Survival (PFS) End Point | From start of study treatment to 12 months, at every 12 weeks | PFS defined as the time from randomization (randomization referred to the date of treatment assignment) to disease progression (radiological or clinical, whichever was earlier) or death (if death occurred before progression was documented). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. |
| Overall Survival Rate | 12 months | The overall survival (OS) time in days was calculated as number of days since the day of first dose of study medication until the date of death. |
| Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | From start of study treatment until 12 months | The subject completed the full BPI (short form) paper questionnaire, and clinical staff completed the analgesic log. The test consists of 10 questions addressing severity, location, chronicity, and amount of relief. In question 3, subjects with pain are asked to evaluate the severity of pain at worst in the past 24 hours in a 0 to 10 scale, with 0 indicating no pain, and 10 indicating the worst pain. |
| Exploratory Efficacy: Percent Change From Baseline in Circulating Tumor Cells at Day 85 | Baseline, Day 85, expanded safety cohort | CTCs were measured to follow the evolution of the level of CTCs after treatment. |
Countries
France, United States
Participant flow
Recruitment details
Study was conducted at seven study centers in United States and one study center in France, between 23 July 2010 (first subject first visit) and 16 June 2015 (last subject last visit).
Pre-assignment details
A total of 70 subjects were enrolled in the study. Of these 17 were in the dose escalation cohort in three dose groups of radium-223 and docetaxel. The remaining 53 subjects were in expanded safety cohort, of them 46 were dosed; 33 received a combination of radium-223 dichloride plus docetaxel and 13 subjects received docetaxel alone.
Participants by arm
| Arm | Count |
|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation Subjects received two intravenous injections of Alpharadin (Radium \[Ra\]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m\^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation. | 7 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation. | 3 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks; unless DLT or other safety concerns limited the dose escalation. | 7 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m\^2 every three weeks. | 36 |
| Docetaxel 75 mg/m^2 - Safety Cohort Subjects received docetaxel at 75 mg/m\^2 twice daily every three weeks. | 17 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 | 3 | 1 |
| Overall Study | Disease progression | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Home hospice since July 2013 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Sponsor Decision | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Subject entered hospice | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Subjects untreated | 0 | 0 | 0 | 3 | 4 |
| Overall Study | Too ill to come in for the visit | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Went on hospice | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 3 | 2 |
Baseline characteristics
| Characteristic | Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Docetaxel 75 mg/m^2 - Safety Cohort | Total |
|---|---|---|---|---|---|---|
| Age, Customized <18 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized >65 years | 5 participants | 1 participants | 4 participants | 25 participants | 10 participants | 45 participants |
| Age, Customized Between 18 and 65 years | 2 participants | 2 participants | 3 participants | 11 participants | 7 participants | 25 participants |
| Gender Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Gender Male | 7 Participants | 3 Participants | 7 Participants | 36 Participants | 17 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 7 | 3 / 3 | 7 / 7 | 33 / 33 | 13 / 13 |
| serious Total, serious adverse events | 4 / 7 | 0 / 3 | 2 / 7 | 7 / 33 | 4 / 13 |
Outcome results
Primary
Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Time frame: Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)
Population: Only randomized participants who have this outcome measure tested were assessed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Change at Day 190 (n= 0,0,0,23,6) | NA gram per liter (G/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Change at Day 106 (n=1,0,0,27,11 ) | 1 gram per liter (G/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin: Change at Day 106 (n=1,0,0,27,11) | -2 gram per liter (G/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Change at Day 190 (n= 0,0,0,24,6) | NA gram per liter (G/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Change at Day 106 (n=1,0,0,27,11 ) | -10 gram per liter (G/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin: Change at Day 190 (n= 0,0,0,24,6) | NA gram per liter (G/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Baseline (n= 7,3,7,35,13) | 122.43 gram per liter (G/L) | Standard Deviation 14.581 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Baseline (n= 7,3,7,35,13) | 70.3 gram per liter (G/L) | Standard Deviation 4.23 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin Baseline (n= 7,3,7,35,13) | 42 gram per liter (G/L) | Standard Deviation 3 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Baseline (n= 7,3,7,35,13) | 120.67 gram per liter (G/L) | Standard Deviation 16.166 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Change at Day 190 (n= 0,0,0,24,6) | NA gram per liter (G/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Baseline (n= 7,3,7,35,13) | 69.7 gram per liter (G/L) | Standard Deviation 8.5 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Change at Day 106 (n=1,0,0,27,11 ) | NA gram per liter (G/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin: Change at Day 190 (n= 0,0,0,24,6) | NA gram per liter (G/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Change at Day 190 (n= 0,0,0,23,6) | NA gram per liter (G/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin: Change at Day 106 (n=1,0,0,27,11) | NA gram per liter (G/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin Baseline (n= 7,3,7,35,13) | 43 gram per liter (G/L) | Standard Deviation 4 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Change at Day 106 (n=1,0,0,27,11 ) | NA gram per liter (G/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Change at Day 190 (n= 0,0,0,24,6) | NA gram per liter (G/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin Baseline (n= 7,3,7,35,13) | 43 gram per liter (G/L) | Standard Deviation 3.56 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin: Change at Day 106 (n=1,0,0,27,11) | NA gram per liter (G/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin: Change at Day 190 (n= 0,0,0,24,6) | NA gram per liter (G/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Baseline (n= 7,3,7,35,13) | 70.4 gram per liter (G/L) | Standard Deviation 4.89 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Change at Day 106 (n=1,0,0,27,11 ) | NA gram per liter (G/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Baseline (n= 7,3,7,35,13) | 120.43 gram per liter (G/L) | Standard Deviation 8.522 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Change at Day 106 (n=1,0,0,27,11 ) | NA gram per liter (G/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Change at Day 190 (n= 0,0,0,23,6) | NA gram per liter (G/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Baseline (n= 7,3,7,35,13) | 68.7 gram per liter (G/L) | Standard Deviation 4.45 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Change at Day 190 (n= 0,0,0,24,6) | -5.3 gram per liter (G/L) | Standard Deviation 3.63 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin: Change at Day 190 (n= 0,0,0,24,6) | -2.3 gram per liter (G/L) | Standard Deviation 3.33 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Baseline (n= 7,3,7,35,13) | 122.82 gram per liter (G/L) | Standard Deviation 10.939 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin: Change at Day 106 (n=1,0,0,27,11) | -1.3 gram per liter (G/L) | Standard Deviation 2.98 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Change at Day 190 (n= 0,0,0,23,6) | -13.65 gram per liter (G/L) | Standard Deviation 10.853 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Change at Day 106 (n=1,0,0,27,11 ) | -8.81 gram per liter (G/L) | Standard Deviation 8.2 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin Baseline (n= 7,3,7,35,13) | 42.7 gram per liter (G/L) | Standard Deviation 3.25 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Change at Day 106 (n=1,0,0,27,11 ) | -3.9 gram per liter (G/L) | Standard Deviation 3.79 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin Baseline (n= 7,3,7,35,13) | 42.3 gram per liter (G/L) | Standard Deviation 4.09 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Baseline (n= 7,3,7,35,13) | 69.1 gram per liter (G/L) | Standard Deviation 5.33 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Change at Day 190 (n= 0,0,0,24,6) | -3.7 gram per liter (G/L) | Standard Deviation 4.18 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin: Change at Day 190 (n= 0,0,0,24,6) | -0.5 gram per liter (G/L) | Standard Deviation 2.07 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Protein: Change at Day 106 (n=1,0,0,27,11 ) | -3.8 gram per liter (G/L) | Standard Deviation 2.56 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Change at Day 190 (n= 0,0,0,23,6) | -10.67 gram per liter (G/L) | Standard Deviation 13.794 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Change at Day 106 (n=1,0,0,27,11 ) | -14.27 gram per liter (G/L) | Standard Deviation 9.067 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Hemoglobin: Baseline (n= 7,3,7,35,13) | 120.23 gram per liter (G/L) | Standard Deviation 12.05 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period | Albumin: Change at Day 106 (n=1,0,0,27,11) | -1.2 gram per liter (G/L) | Standard Deviation 2.75 |
Primary
Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Time frame: Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)
Population: Only participants who received treatment were assessed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Baseline (n= 7,3,7,33,13) | 17.6 units per liter (U/L) | Standard Deviation 5.68 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Baseline (n= 7,3,7,33,13) | 313.3 units per liter (U/L) | Standard Deviation 243.9 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Change at Day 190 (n= 0,0,0,24,6) | NA units per liter (U/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Change at Day 106 (n=1,0,0,27,11) | -134 units per liter (U/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Change at Day 190 (n= 0,0,0,24,6) | NA units per liter (U/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Change at Day 106 (n= 1,0,0,27,11) | 15 units per liter (U/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Change at Day 190 (n= 0,0,0,24,6) | NA units per liter (U/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Baseline (n= 7,3,7,33,13) | 533.1 units per liter (U/L) | Standard Deviation 656.36 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Change at Day 106 (n=1,0,0,27,11 ) | 100 units per liter (U/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Change at Day 106 (n= 1,0,0,27,11) | NA units per liter (U/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Change at Day 190 (n= 0,0,0,24,6) | NA units per liter (U/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Baseline (n= 7,3,7,33,13) | 144 units per liter (U/L) | Standard Deviation 89.2 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Change at Day 190 (n= 0,0,0,24,6) | NA units per liter (U/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Baseline (n= 7,3,7,33,13) | 17 units per liter (U/L) | Standard Deviation 6.56 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Change at Day 106 (n=1,0,0,27,11 ) | NA units per liter (U/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Change at Day 190 (n= 0,0,0,24,6) | NA units per liter (U/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Baseline (n= 7,3,7,33,13) | 179 units per liter (U/L) | Standard Deviation 22.52 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Change at Day 106 (n=1,0,0,27,11) | NA units per liter (U/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Change at Day 106 (n= 1,0,0,27,11) | NA units per liter (U/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Baseline (n= 7,3,7,33,13) | 18.9 units per liter (U/L) | Standard Deviation 5.9 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Baseline (n= 7,3,7,33,13) | 214.4 units per liter (U/L) | Standard Deviation 38.92 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Change at Day 106 (n=1,0,0,27,11 ) | NA units per liter (U/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Change at Day 190 (n= 0,0,0,24,6) | NA units per liter (U/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Change at Day 190 (n= 0,0,0,24,6) | NA units per liter (U/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Change at Day 106 (n=1,0,0,27,11) | NA units per liter (U/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Change at Day 190 (n= 0,0,0,24,6) | NA units per liter (U/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Baseline (n= 7,3,7,33,13) | 224.6 units per liter (U/L) | Standard Deviation 115.08 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Change at Day 190 (n= 0,0,0,24,6) | -119.3 units per liter (U/L) | Standard Deviation 112.21 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Baseline (n= 7,3,7,33,13) | 218.2 units per liter (U/L) | Standard Deviation 207.63 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Change at Day 190 (n= 0,0,0,24,6) | 1.1 units per liter (U/L) | Standard Deviation 8.67 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Baseline (n= 7,3,7,33,13) | 19.8 units per liter (U/L) | Standard Deviation 9.82 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Change at Day 106 (n= 1,0,0,27,11) | 10.7 units per liter (U/L) | Standard Deviation 58.14 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Change at Day 106 (n=1,0,0,27,11 ) | 2.9 units per liter (U/L) | Standard Deviation 13.54 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Change at Day 190 (n= 0,0,0,24,6) | 16.9 units per liter (U/L) | Standard Deviation 39.74 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Change at Day 106 (n=1,0,0,27,11) | -119.6 units per liter (U/L) | Standard Deviation 153.1 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Baseline (n= 7,3,7,33,13) | 212.8 units per liter (U/L) | Standard Deviation 71.07 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Change at Day 190 (n= 0,0,0,24,6) | 17.5 units per liter (U/L) | Standard Deviation 100.85 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Baseline (n= 7,3,7,33,13) | 195.9 units per liter (U/L) | Standard Deviation 110.86 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Change at Day 106 (n=1,0,0,27,11) | -78.9 units per liter (U/L) | Standard Deviation 46.35 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AP: Change at Day 190 (n= 0,0,0,24,6) | -116.8 units per liter (U/L) | Standard Deviation 52.21 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Baseline (n= 7,3,7,33,13) | 19.8 units per liter (U/L) | Standard Deviation 10.78 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Change at Day 106 (n=1,0,0,27,11 ) | -2.2 units per liter (U/L) | Standard Deviation 11.75 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | AAT: Change at Day 190 (n= 0,0,0,24,6) | -3.7 units per liter (U/L) | Standard Deviation 13.81 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Baseline (n= 7,3,7,33,13) | 203.4 units per liter (U/L) | Standard Deviation 61.68 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period | LD: Change at Day 106 (n= 1,0,0,27,11) | 45.1 units per liter (U/L) | Standard Deviation 93.58 |
Primary
Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Time frame: Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)
Population: Only participants who received treatment were assessed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Baseline (n= 7,3,7,33,13) | 8.9 micromole(s)/litre | Standard Deviation 3.8 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Change at Day 106 (n= 1,0,0,27,11) | 2 micromole(s)/litre | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Change at Day 190 (n= 0,0,0,24,6) | NA micromole(s)/litre | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Baseline (n= 7,3,7,33,13) | 92.33 micromole(s)/litre | Standard Deviation 33.126 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Change at Day 106 (n= 1,0,0,27,11) | 63.6 micromole(s)/litre | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Change at Day 190 (n= 0,0,0,24,6) | NA micromole(s)/litre | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Change at Day 106 (n= 1,0,0,27,11) | NA micromole(s)/litre | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Change at Day 190 (n= 0,0,0,24,6) | NA micromole(s)/litre | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Baseline (n= 7,3,7,33,13) | 6.7 micromole(s)/litre | Standard Deviation 1.15 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Change at Day 190 (n= 0,0,0,24,6) | NA micromole(s)/litre | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Baseline (n= 7,3,7,33,13) | 73.67 micromole(s)/litre | Standard Deviation 9.5 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Change at Day 106 (n= 1,0,0,27,11) | NA micromole(s)/litre | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Baseline (n= 7,3,7,33,13) | 70.86 micromole(s)/litre | Standard Deviation 10.938 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Change at Day 106 (n= 1,0,0,27,11) | NA micromole(s)/litre | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Baseline (n= 7,3,7,33,13) | 7.1 micromole(s)/litre | Standard Deviation 3.98 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Change at Day 190 (n= 0,0,0,24,6) | NA micromole(s)/litre | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Change at Day 106 (n= 1,0,0,27,11) | NA micromole(s)/litre | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Change at Day 190 (n= 0,0,0,24,6) | NA micromole(s)/litre | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Baseline (n= 7,3,7,33,13) | 70.07 micromole(s)/litre | Standard Deviation 19.138 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Change at Day 106 (n= 1,0,0,27,11) | 0.2 micromole(s)/litre | Standard Deviation 1.84 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Change at Day 190 (n= 0,0,0,24,6) | -0.9 micromole(s)/litre | Standard Deviation 1.56 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Change at Day 190 (n= 0,0,0,24,6) | 0.59 micromole(s)/litre | Standard Deviation 11.889 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Change at Day 106 (n= 1,0,0,27,11) | 0.74 micromole(s)/litre | Standard Deviation 12.273 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Baseline (n= 7,3,7,33,13) | 7.5 micromole(s)/litre | Standard Deviation 2.62 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Change at Day 106 (n= 1,0,0,27,11) | -0.7 micromole(s)/litre | Standard Deviation 7.232 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Change at Day 190 (n= 0,0,0,24,6) | 0.3 micromole(s)/litre | Standard Deviation 1.51 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Change at Day 106 (n= 1,0,0,27,11) | -0.8 micromole(s)/litre | Standard Deviation 1.72 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Change at Day 190 (n= 0,0,0,24,6) | -0.17 micromole(s)/litre | Standard Deviation 13.31 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Creatinine: Baseline (n= 7,3,7,33,13) | 75.5 micromole(s)/litre | Standard Deviation 11.614 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period | Bilirubin: Baseline (n= 7,3,7,33,13) | 7 micromole(s)/litre | Standard Deviation 2.08 |
Primary
Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Time frame: Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)
Population: Only participants who received treatment were assessed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Baseline (n= 7,3,7,33,13) | 0.93 millimole(s)/liter | Standard Deviation 0.055 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Change at Day 106 (n= 1,0,0,27,11) | 0 millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Change at Day 106 (n= 1,0,0,27,11) | 0.2 millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Baseline (n= 7,3,7,33,13) | 136.1 millimole(s)/liter | Standard Deviation 4.1 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Baseline (n= 7,3,7,33,13) | 1.021 millimole(s)/liter | Standard Deviation 0.168 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Change at Day 106 (n= 1,0,0,27,11) | 1.5 millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Change at Day 106 (n= 1,0,0,27,11) | 0 millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Baseline (n= 7,3,7,33,13) | 101.4 millimole(s)/liter | Standard Deviation 3.21 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Baseline (n= 7,3,7,33,13) | 9.14 millimole(s)/liter | Standard Deviation 3.092 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Baseline (n= 7,3,7,33,13) | 2.231 millimole(s)/liter | Standard Deviation 0.1523 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Change at Day 106 (n= 1,0,0,27,11) | 1.1 millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Change at Day 106 (n= 1,0,0,27,11) | -1.9 millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Change at Day 106 (n= 1,0,0,27,11) | -4.4 millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Baseline (n= 7,3,7,33,13) | 4.34 millimole(s)/liter | Standard Deviation 0.541 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Baseline (n= 7,3,7,33,13) | 4.47 millimole(s)/liter | Standard Deviation 0.306 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Baseline (n= 7,3,7,33,13) | 0.86 millimole(s)/liter | Standard Deviation 0 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Baseline (n= 7,3,7,33,13) | 137.7 millimole(s)/liter | Standard Deviation 3.51 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Baseline (n= 7,3,7,33,13) | 2.38 millimole(s)/liter | Standard Deviation 0.0872 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Baseline (n= 7,3,7,33,13) | 1.167 millimole(s)/liter | Standard Deviation 0.2466 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Baseline (n= 7,3,7,33,13) | 101.7 millimole(s)/liter | Standard Deviation 2.52 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Baseline (n= 7,3,7,33,13) | 7.83 millimole(s)/liter | Standard Deviation 1.041 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Baseline (n= 7,3,7,33,13) | 4.39 millimole(s)/liter | Standard Deviation 0.09 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Baseline (n= 7,3,7,33,13) | 6.79 millimole(s)/liter | Standard Deviation 2.059 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Baseline (n= 7,3,7,33,13) | 2.309 millimole(s)/liter | Standard Deviation 0.071 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Baseline (n= 7,3,7,33,13) | 102 millimole(s)/liter | Standard Deviation 2.77 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Baseline (n= 7,3,7,33,13) | 0.86 millimole(s)/liter | Standard Deviation 0.088 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Baseline (n= 7,3,7,33,13) | 0.993 millimole(s)/liter | Standard Deviation 0.369 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Change at Day 190 (n= 0,0,0,24,6) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Baseline (n= 7,3,7,33,13) | 137.4 millimole(s)/liter | Standard Deviation 2.51 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Change at Day 106 (n= 1,0,0,27,11) | NA millimole(s)/liter | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Baseline (n= 7,3,7,33,13) | 2.357 millimole(s)/liter | Standard Deviation 0.1121 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Change at Day 106 (n= 1,0,0,27,11) | -0.6 millimole(s)/liter | Standard Deviation 2.28 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Change at Day 106 (n= 1,0,0,27,11) | 0.086 millimole(s)/liter | Standard Deviation 0.1369 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Change at Day 190 (n= 0,0,0,24,6) | -0.055 millimole(s)/liter | Standard Deviation 0.1225 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Baseline (n= 7,3,7,33,13) | 103.2 millimole(s)/liter | Standard Deviation 2.75 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Change at Day 190 (n= 0,0,0,24,6) | -0.15 millimole(s)/liter | Standard Deviation 1.508 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Change at Day 190 (n= 0,0,0,24,6) | 0.04 millimole(s)/liter | Standard Deviation 0.422 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Change at Day 190 (n= 0,0,0,24,6) | 0.128 millimole(s)/liter | Standard Deviation 0.1734 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Baseline (n= 7,3,7,33,13) | 7.03 millimole(s)/liter | Standard Deviation 2.304 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Change at Day 106 (n= 1,0,0,27,11) | 0.06 millimole(s)/liter | Standard Deviation 0.366 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Change at Day 106 (n= 1,0,0,27,11) | -0.065 millimole(s)/liter | Standard Deviation 0.148 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Change at Day 106 (n= 1,0,0,27,11) | -0.26 millimole(s)/liter | Standard Deviation 1.587 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Baseline (n= 7,3,7,33,13) | 0.85 millimole(s)/liter | Standard Deviation 0.072 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Change at Day 190 (n= 0,0,0,24,6) | -0.5 millimole(s)/liter | Standard Deviation 2.41 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Change at Day 106 (n= 1,0,0,27,11) | -0.02 millimole(s)/liter | Standard Deviation 0.058 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Baseline (n= 7,3,7,33,13) | 1.058 millimole(s)/liter | Standard Deviation 0.1763 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Change at Day 106 (n= 1,0,0,27,11) | 0 millimole(s)/liter | Standard Deviation 2.72 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Change at Day 190 (n= 0,0,0,24,6) | 0 millimole(s)/liter | Standard Deviation 3.35 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Baseline (n= 7,3,7,33,13) | 138.5 millimole(s)/liter | Standard Deviation 2.49 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Change at Day 190 (n= 0,0,0,24,6) | -0.01 millimole(s)/liter | Standard Deviation 0.079 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Baseline (n= 7,3,7,33,13) | 4.29 millimole(s)/liter | Standard Deviation 0.277 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Change at Day 190 (n= 0,0,0,24,6) | -0.06 millimole(s)/liter | Standard Deviation 0.045 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Baseline (n= 7,3,7,33,13) | 137.2 millimole(s)/liter | Standard Deviation 4.72 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Baseline (n= 7,3,7,33,13) | 4.3 millimole(s)/liter | Standard Deviation 0.443 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Baseline (n= 7,3,7,33,13) | 101.3 millimole(s)/liter | Standard Deviation 3.99 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Change at Day 106 (n= 1,0,0,27,11) | 0.11 millimole(s)/liter | Standard Deviation 0.336 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Change at Day 190 (n= 0,0,0,24,6) | -0.143 millimole(s)/liter | Standard Deviation 0.1536 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Change at Day 190 (n= 0,0,0,24,6) | 2.3 millimole(s)/liter | Standard Deviation 1.37 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Potassium: Change at Day 190 (n= 0,0,0,24,6) | 0.03 millimole(s)/liter | Standard Deviation 0.501 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Change at Day 106 (n= 1,0,0,27,11) | -0.019 millimole(s)/liter | Standard Deviation 0.104 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Baseline (n= 7,3,7,33,13) | 1.145 millimole(s)/liter | Standard Deviation 0.1844 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Calcium: Baseline (n= 7,3,7,33,13) | 2.307 millimole(s)/liter | Standard Deviation 0.1437 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Change at Day 106 (n= 1,0,0,27,11) | -0.061 millimole(s)/liter | Standard Deviation 0.2287 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Change at Day 190 (n= 0,0,0,24,6) | 0.7 millimole(s)/liter | Standard Deviation 1.122 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Sodium: Change at Day 106 (n= 1,0,0,27,11) | 0.8 millimole(s)/liter | Standard Deviation 2.56 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Phosphate: Change at Day 190 (n= 0,0,0,24,6) | 0.203 millimole(s)/liter | Standard Deviation 0.1813 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Change at Day 106 (n= 1,0,0,27,11) | -0.26 millimole(s)/liter | Standard Deviation 1.531 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Urea: Baseline (n= 7,3,7,33,13) | 7.78 millimole(s)/liter | Standard Deviation 2.312 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Baseline (n= 7,3,7,33,13) | 0.84 millimole(s)/liter | Standard Deviation 0.073 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Magnesium: Change at Day 106 (n= 1,0,0,27,11) | -0.04 millimole(s)/liter | Standard Deviation 0.036 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Change at Day 190 (n= 0,0,0,24,6) | 2.5 millimole(s)/liter | Standard Deviation 1.38 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period | Chloride: Change at Day 106 (n= 1,0,0,27,11) | 1.5 millimole(s)/liter | Standard Deviation 2.38 |
Primary
Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Time frame: Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)
Population: Only participants who received treatment were assessed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Baseline (n= 7,3,7,33,13) | 3.99 tetra per liter (TI/L) | Standard Deviation 0.376 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Change at Day 190 (n= 0,0,0,23,6) | NA tetra per liter (TI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Change at Day 106 (n= 1,0,0,27,11) | -0.4 tetra per liter (TI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Change at Day 106 (n= 1,0,0,27,11) | NA tetra per liter (TI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Baseline (n= 7,3,7,33,13) | 3.9 tetra per liter (TI/L) | Standard Deviation 0.361 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Change at Day 190 (n= 0,0,0,23,6) | NA tetra per liter (TI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Baseline (n= 7,3,7,33,13) | 3.9 tetra per liter (TI/L) | Standard Deviation 0.327 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Change at Day 106 (n= 1,0,0,27,11) | NA tetra per liter (TI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Change at Day 190 (n= 0,0,0,23,6) | NA tetra per liter (TI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Baseline (n= 7,3,7,33,13) | 3.98 tetra per liter (TI/L) | Standard Deviation 0.378 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Change at Day 190 (n= 0,0,0,23,6) | -0.39 tetra per liter (TI/L) | Standard Deviation 0.287 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Change at Day 106 (n= 1,0,0,27,11) | -0.25 tetra per liter (TI/L) | Standard Deviation 0.233 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Change at Day 106 (n= 1,0,0,27,11) | -0.32 tetra per liter (TI/L) | Standard Deviation 0.429 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Baseline (n= 7,3,7,33,13) | 4.02 tetra per liter (TI/L) | Standard Deviation 0.519 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period | Erythrocytes: Change at Day 190 (n= 0,0,0,23,6) | -0.15 tetra per liter (TI/L) | Standard Deviation 0.653 |
Primary
Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Time frame: Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)
Population: Only participants who received treatment were assessed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Baseline (n= 7,3,7,33,13) | 214.1 giga per liter (GI/L) | Standard Deviation 58.05 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Change at Day 106 (n= 1,0,0,27,11) | -0.12 giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Change at Day 106 (n= 1,0,0,27,11) | 18.7 giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Baseline (n= 7,3,7,33,13) | 0.013 giga per liter (GI/L) | Standard Deviation 0.0221 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Baseline (n= 7,3,7,33,13) | 0.04 giga per liter (GI/L) | Standard Deviation 0.0622 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Baseline (n= 7,3,7,33,13) | 7.809 giga per liter (GI/L) | Standard Deviation 4.0998 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Change at Day 106 (n= 1,0,0,27,11) | 169 giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Baseline (n= 7,3,7,33,13) | 1.044 giga per liter (GI/L) | Standard Deviation 0.4687 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Change at Day 106 (n= 1,0,0,27,11) | 517.3 giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Change at Day 106 (n= 1,0,0,27,11) | 0.02 giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Change at Day 106 (n= 1,0,0,27,11) | 0.12 giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Baseline (n= 7,3,7,33,13) | 9.13 giga per liter (GI/L) | Standard Deviation 4.43 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Change at Day 106 (n= 1,0,0,27,11) | 1.3 giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Baseline (n= 7,3,7,33,13) | 0.224 giga per liter (GI/L) | Standard Deviation 0.2319 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Baseline (n= 7,3,7,33,13) | 0.007 giga per liter (GI/L) | Standard Deviation 0.0058 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Baseline (n= 7,3,7,33,13) | 4.71 giga per liter (GI/L) | Standard Deviation 1.54 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Baseline (n= 7,3,7,33,13) | 5.83 giga per liter (GI/L) | Standard Deviation 1.858 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Baseline (n= 7,3,7,33,13) | 0.01 giga per liter (GI/L) | Standard Deviation 0.01 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Baseline (n= 7,3,7,33,13) | 196.3 giga per liter (GI/L) | Standard Deviation 51.64 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Baseline (n= 7,3,7,33,13) | 1.003 giga per liter (GI/L) | Standard Deviation 0.45 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Baseline (n= 7,3,7,33,13) | 0.103 giga per liter (GI/L) | Standard Deviation 0.085 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Baseline (n= 7,3,7,33,13) | 0.014 giga per liter (GI/L) | Standard Deviation 0.0151 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Baseline (n= 7,3,7,33,13) | 266.6 giga per liter (GI/L) | Standard Deviation 77.43 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Baseline (n= 7,3,7,33,13) | 8.34 giga per liter (GI/L) | Standard Deviation 2.783 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Baseline (n= 7,3,7,33,13) | 0.81 giga per liter (GI/L) | Standard Deviation 0.4679 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Baseline (n= 7,3,7,33,13) | 0.153 giga per liter (GI/L) | Standard Deviation 0.1379 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Baseline (n= 7,3,7,33,13) | 7.359 giga per liter (GI/L) | Standard Deviation 2.7781 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Baseline (n= 7,3,7,33,13) | 0.011 giga per liter (GI/L) | Standard Deviation 0.0107 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Change at Day 106 (n= 1,0,0,27,11) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Change at Day 190 (n= 0,0,0,23,6) | NA giga per liter (GI/L) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Change at Day 106 (n= 1,0,0,27,11) | -0.229 giga per liter (GI/L) | Standard Deviation 0.5593 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Baseline (n= 7,3,7,33,13) | 0.243 giga per liter (GI/L) | Standard Deviation 0.2466 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Baseline (n= 7,3,7,33,13) | 1.001 giga per liter (GI/L) | Standard Deviation 0.5902 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Change at Day 190 (n= 0,0,0,23,6) | -0.003 giga per liter (GI/L) | Standard Deviation 0.0136 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Change at Day 106 (n= 1,0,0,27,11) | -0.011 giga per liter (GI/L) | Standard Deviation 0.2959 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Change at Day 190 (n= 0,0,0,23,6) | -0.12 giga per liter (GI/L) | Standard Deviation 2.603 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Change at Day 106 (n= 1,0,0,27,11) | 0.001 giga per liter (GI/L) | Standard Deviation 0.0169 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Change at Day 190 (n= 0,0,0,23,6) | -0.014 giga per liter (GI/L) | Standard Deviation 0.3185 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Change at Day 106 (n= 1,0,0,27,11) | -0.1 giga per liter (GI/L) | Standard Deviation 2.086 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Baseline (n= 7,3,7,33,13) | 0.054 giga per liter (GI/L) | Standard Deviation 0.0734 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Baseline (n= 7,3,7,33,13) | 7.67 giga per liter (GI/L) | Standard Deviation 2.871 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Change at Day 106 (n= 1,0,0,27,11) | -0.043 giga per liter (GI/L) | Standard Deviation 0.0797 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Change at Day 190 (n= 0,0,0,23,6) | -22 giga per liter (GI/L) | Standard Deviation 51.04 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Baseline (n= 7,3,7,33,13) | 6.363 giga per liter (GI/L) | Standard Deviation 2.8618 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Change at Day 190 (n= 0,0,0,23,6) | -0.049 giga per liter (GI/L) | Standard Deviation 0.0786 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Change at Day 106 (n= 1,0,0,27,11) | -3.1 giga per liter (GI/L) | Standard Deviation 51.39 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Baseline (n= 7,3,7,33,13) | 0.012 giga per liter (GI/L) | Standard Deviation 0.0137 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Change at Day 106 (n= 1,0,0,27,11) | 0.178 giga per liter (GI/L) | Standard Deviation 2.2991 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Change at Day 190 (n= 0,0,0,23,6) | -0.395 giga per liter (GI/L) | Standard Deviation 0.3917 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Baseline (n= 7,3,7,33,13) | 259.6 giga per liter (GI/L) | Standard Deviation 69.39 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Change at Day 190 (n= 0,0,0,23,6) | 0.341 giga per liter (GI/L) | Standard Deviation 2.4734 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Change at Day 190 (n= 0,0,0,23,6) | -0.085 giga per liter (GI/L) | Standard Deviation 0.6832 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Change at Day 106 (n= 1,0,0,27,11) | -0.008 giga per liter (GI/L) | Standard Deviation 0.0995 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Baseline (n= 7,3,7,33,13) | 0.018 giga per liter (GI/L) | Standard Deviation 0.0121 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Change at Day 106 (n= 1,0,0,27,11) | 33 giga per liter (GI/L) | Standard Deviation 55.17 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Change at Day 190 (n= 0,0,0,23,6) | 1.65 giga per liter (GI/L) | Standard Deviation 1.946 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Change at Day 190 (n= 0,0,0,23,6) | 2.038 giga per liter (GI/L) | Standard Deviation 1.8799 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Change at Day 106 (n= 1,0,0,27,11) | 2.622 giga per liter (GI/L) | Standard Deviation 2.5672 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Change at Day 106 (n= 1,0,0,27,11) | -0.111 giga per liter (GI/L) | Standard Deviation 0.4164 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Change at Day 190 (n= 0,0,0,23,6) | -0.023 giga per liter (GI/L) | Standard Deviation 0.0186 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Change at Day 106 (n= 1,0,0,27,11) | 2.44 giga per liter (GI/L) | Standard Deviation 2.263 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Baseline (n= 7,3,7,33,13) | 1.068 giga per liter (GI/L) | Standard Deviation 0.5751 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Baseline (n= 7,3,7,33,13) | 240.6 giga per liter (GI/L) | Standard Deviation 52.17 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Change at Day 190 (n= 0,0,0,23,6) | -0.27 giga per liter (GI/L) | Standard Deviation 0.2964 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Change at Day 190 (n= 0,0,0,23,6) | -0.015 giga per liter (GI/L) | Standard Deviation 0.0105 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Leukocytes: Baseline (n= 7,3,7,33,13) | 6.71 giga per liter (GI/L) | Standard Deviation 2.308 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Basophils: Change at Day 106 (n= 1,0,0,27,11) | -0.001 giga per liter (GI/L) | Standard Deviation 0.0197 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Lymphocytes: Change at Day 106 (n= 1,0,0,27,11) | -0.063 giga per liter (GI/L) | Standard Deviation 0.5129 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Eosinophils: Baseline (n= 7,3,7,33,13) | 0.043 giga per liter (GI/L) | Standard Deviation 0.0407 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Neutrophils: Baseline (n= 7,3,7,33,13) | 5.205 giga per liter (GI/L) | Standard Deviation 2.1487 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Platelets: Change at Day 190 (n= 0,0,0,23,6) | 32.3 giga per liter (GI/L) | Standard Deviation 68.54 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period | Monocytes: Baseline (n= 7,3,7,33,13) | 0.375 giga per liter (GI/L) | Standard Deviation 0.4203 |
Primary
Changes From Baseline in Heart Rate During the Treatment Period
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Time frame: From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)
Population: Only participants who received treatment were assessed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | NA beats per min | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | -0.2 beats per min | Standard Deviation 6.49 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | NA beats per min | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | -4.3 beats per min | Standard Deviation 9.35 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | NA beats per min | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | 0.7 beats per min | Standard Deviation 7.28 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Baseline (n= 7,3,7,33,13) | 88.6 beats per min | Standard Deviation 18.84 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | NA beats per min | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | NA beats per min | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | NA beats per min | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | NA beats per min | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | 18.3 beats per min | Standard Deviation 14.57 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | NA beats per min | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | 13 beats per min | Standard Deviation 21.17 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | NA beats per min | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | NA beats per min | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | NA beats per min | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | NA beats per min | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | 9.7 beats per min | Standard Deviation 18.72 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Baseline (n= 7,3,7,33,13) | 58 beats per min | Standard Deviation 9.17 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | NA beats per min | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | NA beats per min | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | NA beats per min | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | 0.9 beats per min | Standard Deviation 10.32 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Baseline (n= 7,3,7,33,13) | 80 beats per min | Standard Deviation 9.93 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | NA beats per min | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | NA beats per min | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | -0.6 beats per min | Standard Deviation 7.76 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | 6.5 beats per min | Standard Deviation 11.47 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | NA beats per min | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | 3.6 beats per min | Standard Deviation 16.91 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Baseline (n= 7,3,7,33,13) | 77.9 beats per min | Standard Deviation 14.18 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | 2 beats per min | Standard Deviation 11.39 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | 2.8 beats per min | Standard Deviation 11.13 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | 3.4 beats per min | Standard Deviation 14.48 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | 2.9 beats per min | Standard Deviation 16.17 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | 2.2 beats per min | Standard Deviation 13.93 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | 2.2 beats per min | Standard Deviation 15.88 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | 0.8 beats per min | Standard Deviation 19.18 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | 2.6 beats per min | Standard Deviation 16.01 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | 9.2 beats per min | Standard Deviation 11.67 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | 7.2 beats per min | Standard Deviation 10.27 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | 5.1 beats per min | Standard Deviation 9.41 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | 18 beats per min | Standard Deviation 11.31 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | 8 beats per min | Standard Deviation 7.72 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | 4.9 beats per min | Standard Deviation 11.54 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | 7.2 beats per min | Standard Deviation 12.17 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | 7.5 beats per min | Standard Deviation 5.86 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Baseline (n= 7,3,7,33,13) | 73.3 beats per min | Standard Deviation 12.01 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Heart Rate During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | 15.3 beats per min | Standard Deviation 14.38 |
Primary
Changes From Baseline in Respiratory Rate During the Treatment Period
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Time frame: From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)
Population: Only participants who received treatment were assessed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | NA breaths/min | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | NA breaths/min | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | -0.5 breaths/min | Standard Deviation 2.81 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | 0 breaths/min | Standard Deviation 1.26 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | NA breaths/min | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | NA breaths/min | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Baseline (n= 7,3,7,33,13) | 19.3 breaths/min | Standard Deviation 1.63 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | NA breaths/min | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | NA breaths/min | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | -1.7 breaths/min | Standard Deviation 2.34 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | NA breaths/min | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | NA breaths/min | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Baseline (n= 7,3,7,33,13) | 18.7 breaths/min | Standard Deviation 2.31 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | -1.3 breaths/min | Standard Deviation 2.31 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | 1.3 breaths/min | Standard Deviation 4.62 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | 0 breaths/min | Standard Deviation 4 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | NA breaths/min | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | NA breaths/min | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | NA breaths/min | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | NA breaths/min | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | NA breaths/min | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | NA breaths/min | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | -0.3 breaths/min | Standard Deviation 0.82 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | NA breaths/min | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | NA breaths/min | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | -1 breaths/min | Standard Deviation 1.1 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | -0.7 breaths/min | Standard Deviation 1.03 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | NA breaths/min | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Baseline (n= 7,3,7,33,13) | 19.1 breaths/min | Standard Deviation 1.57 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | NA breaths/min | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | 0.9 breaths/min | Standard Deviation 3.69 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | 0 breaths/min | Standard Deviation 4.79 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | 0.7 breaths/min | Standard Deviation 3.38 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | 0 breaths/min | Standard Deviation 3.32 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | 0.4 breaths/min | Standard Deviation 2.82 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | -1 breaths/min | Standard Deviation 3.11 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | -0.8 breaths/min | Standard Deviation 3.54 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | 0 breaths/min | Standard Deviation 3.08 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Baseline (n= 7,3,7,33,13) | 17.1 breaths/min | Standard Deviation 2.67 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | 0.3 breaths/min | Standard Deviation 2.1 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | -0.2 breaths/min | Standard Deviation 1.33 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | 0.8 breaths/min | Standard Deviation 3 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | -0.3 breaths/min | Standard Deviation 2.39 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | 0.5 breaths/min | Standard Deviation 3.27 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | 0.4 breaths/min | Standard Deviation 2.15 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | 0.4 breaths/min | Standard Deviation 1.51 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Baseline (n= 7,3,7,33,13) | 17.5 breaths/min | Standard Deviation 2.79 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | -0.3 breaths/min | Standard Deviation 1.51 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | -0.4 breaths/min | Standard Deviation 2.14 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Respiratory Rate During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | 0.7 breaths/min | Standard Deviation 3.5 |
Primary
Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Time frame: From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)
Population: Only participants who received treatment were assessed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 64 (n= 6,3,6,30,13) | -9.8 millimeters of mercury (mmHg) | Standard Deviation 16.36 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 127 (n= 0,0,0,27,8) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Baseline (n= 7,3,7,33,13) | 81.6 millimeters of mercury (mmHg) | Standard Deviation 5.68 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 148 (n= 0,0,0,25,7) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 169 (n= 0,0,0,25,7) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 22 (n= 6,3,7,33,13) | -2.7 millimeters of mercury (mmHg) | Standard Deviation 10.67 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 106 (n= 0,0,0,28,12) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 106 (n= 0,0,0,28,12) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 169 (n= 0,0,0,25,7) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 43 (n= 6,3,7,32,13) | -8.7 millimeters of mercury (mmHg) | Standard Deviation 12.13 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 85 (n= 0,0,0,28,13) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 85 (n= 0,0,0,28,13) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 190 (n= 0,0,0,24,6) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 190 (n= 0,0,0,24,6) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 148 (n= 0,0,0,25,7) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 22 (n= 6,3,7,33,13) | -2.7 millimeters of mercury (mmHg) | Standard Deviation 13.52 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 64 (n= 6,3,6,30,13) | -8.7 millimeters of mercury (mmHg) | Standard Deviation 7.89 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Baseline (n= 7,3,7,33,13) | 137.7 millimeters of mercury (mmHg) | Standard Deviation 9.11 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 127 (n= 0,0,0,27,8) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 43 (n= 6,3,7,32,13) | -3.7 millimeters of mercury (mmHg) | Standard Deviation 6.65 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 85 (n= 0,0,0,28,13) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 22 (n= 6,3,7,33,13) | 2.3 millimeters of mercury (mmHg) | Standard Deviation 5.51 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 190 (n= 0,0,0,24,6) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 22 (n= 6,3,7,33,13) | 8 millimeters of mercury (mmHg) | Standard Deviation 10.39 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 43 (n= 6,3,7,32,13) | -3 millimeters of mercury (mmHg) | Standard Deviation 9.54 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Baseline (n= 7,3,7,33,13) | 62 millimeters of mercury (mmHg) | Standard Deviation 2 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 148 (n= 0,0,0,25,7) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 106 (n= 0,0,0,28,12) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 127 (n= 0,0,0,27,8) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 127 (n= 0,0,0,27,8) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 106 (n= 0,0,0,28,12) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 148 (n= 0,0,0,25,7) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 64 (n= 6,3,6,30,13) | -11 millimeters of mercury (mmHg) | Standard Deviation 13.45 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 85 (n= 0,0,0,28,13) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 169 (n= 0,0,0,25,7) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 64 (n= 6,3,6,30,13) | -1 millimeters of mercury (mmHg) | Standard Deviation 1.73 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 190 (n= 0,0,0,24,6) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 169 (n= 0,0,0,25,7) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Baseline (n= 7,3,7,33,13) | 113 millimeters of mercury (mmHg) | Standard Deviation 12.12 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 43 (n= 6,3,7,32,13) | 2.7 millimeters of mercury (mmHg) | Standard Deviation 5.03 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 148 (n= 0,0,0,25,7) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 43 (n= 6,3,7,32,13) | -0.9 millimeters of mercury (mmHg) | Standard Deviation 19.37 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 64 (n= 6,3,6,30,13) | -4.2 millimeters of mercury (mmHg) | Standard Deviation 13.66 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 85 (n= 0,0,0,28,13) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 106 (n= 0,0,0,28,12) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 127 (n= 0,0,0,27,8) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 148 (n= 0,0,0,25,7) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 169 (n= 0,0,0,25,7) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 190 (n= 0,0,0,24,6) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Baseline (n= 7,3,7,33,13) | 131.7 millimeters of mercury (mmHg) | Standard Deviation 13.07 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 22 (n= 6,3,7,33,13) | -5 millimeters of mercury (mmHg) | Standard Deviation 12.32 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Baseline (n= 7,3,7,33,13) | 74.1 millimeters of mercury (mmHg) | Standard Deviation 8.86 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 22 (n= 6,3,7,33,13) | 2.6 millimeters of mercury (mmHg) | Standard Deviation 7.57 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 43 (n= 6,3,7,32,13) | 4.1 millimeters of mercury (mmHg) | Standard Deviation 8.13 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 64 (n= 6,3,6,30,13) | -0.2 millimeters of mercury (mmHg) | Standard Deviation 15.93 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 85 (n= 0,0,0,28,13) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 106 (n= 0,0,0,28,12) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 127 (n= 0,0,0,27,8) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 169 (n= 0,0,0,25,7) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 190 (n= 0,0,0,24,6) | NA millimeters of mercury (mmHg) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 127 (n= 0,0,0,27,8) | -4.6 millimeters of mercury (mmHg) | Standard Deviation 19.82 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 169 (n= 0,0,0,25,7) | -3.6 millimeters of mercury (mmHg) | Standard Deviation 16.58 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 190 (n= 0,0,0,24,6) | -8.1 millimeters of mercury (mmHg) | Standard Deviation 18.25 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 127 (n= 0,0,0,27,8) | -1.4 millimeters of mercury (mmHg) | Standard Deviation 14.22 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 169 (n= 0,0,0,25,7) | -1.2 millimeters of mercury (mmHg) | Standard Deviation 10.45 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 106 (n= 0,0,0,28,12) | -6.7 millimeters of mercury (mmHg) | Standard Deviation 21.33 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 85 (n= 0,0,0,28,13) | 1.1 millimeters of mercury (mmHg) | Standard Deviation 10.99 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 43 (n= 6,3,7,32,13) | -1.8 millimeters of mercury (mmHg) | Standard Deviation 12.17 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 148 (n= 0,0,0,25,7) | -2 millimeters of mercury (mmHg) | Standard Deviation 12.19 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 148 (n= 0,0,0,25,7) | -3.9 millimeters of mercury (mmHg) | Standard Deviation 20.09 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 85 (n= 0,0,0,28,13) | -3.1 millimeters of mercury (mmHg) | Standard Deviation 16.55 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 64 (n= 6,3,6,30,13) | -1.4 millimeters of mercury (mmHg) | Standard Deviation 14.66 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 64 (n= 6,3,6,30,13) | -2.5 millimeters of mercury (mmHg) | Standard Deviation 21.75 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Baseline (n= 7,3,7,33,13) | 76.1 millimeters of mercury (mmHg) | Standard Deviation 10.19 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 43 (n= 6,3,7,32,13) | 0.6 millimeters of mercury (mmHg) | Standard Deviation 18.15 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 106 (n= 0,0,0,28,12) | -0.8 millimeters of mercury (mmHg) | Standard Deviation 13.15 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 22 (n= 6,3,7,33,13) | -1.8 millimeters of mercury (mmHg) | Standard Deviation 19.66 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 190 (n= 0,0,0,24,6) | -3.6 millimeters of mercury (mmHg) | Standard Deviation 12.8 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 22 (n= 6,3,7,33,13) | 0.3 millimeters of mercury (mmHg) | Standard Deviation 10.88 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Baseline (n= 7,3,7,33,13) | 139.2 millimeters of mercury (mmHg) | Standard Deviation 17.01 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 22 (n= 6,3,7,33,13) | -6.2 millimeters of mercury (mmHg) | Standard Deviation 16.03 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 43 (n= 6,3,7,32,13) | -11.7 millimeters of mercury (mmHg) | Standard Deviation 10.89 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 169 (n= 0,0,0,25,7) | -6.3 millimeters of mercury (mmHg) | Standard Deviation 17.85 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 169 (n= 0,0,0,25,7) | -9 millimeters of mercury (mmHg) | Standard Deviation 8.6 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 64 (n= 6,3,6,30,13) | -8.7 millimeters of mercury (mmHg) | Standard Deviation 9.21 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 148 (n= 0,0,0,25,7) | -8.9 millimeters of mercury (mmHg) | Standard Deviation 18.02 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 43 (n= 6,3,7,32,13) | -15.3 millimeters of mercury (mmHg) | Standard Deviation 13.91 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 85 (n= 0,0,0,28,13) | -7.6 millimeters of mercury (mmHg) | Standard Deviation 11.2 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 127 (n= 0,0,0,27,8) | -13.4 millimeters of mercury (mmHg) | Standard Deviation 22.01 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 106 (n= 0,0,0,28,12) | -7.9 millimeters of mercury (mmHg) | Standard Deviation 14.13 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 106 (n= 0,0,0,28,12) | -10.4 millimeters of mercury (mmHg) | Standard Deviation 16.33 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 190 (n= 0,0,0,24,6) | -12 millimeters of mercury (mmHg) | Standard Deviation 8.92 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 127 (n= 0,0,0,27,8) | -8 millimeters of mercury (mmHg) | Standard Deviation 9.94 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 85 (n= 0,0,0,28,13) | -3.8 millimeters of mercury (mmHg) | Standard Deviation 17.19 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 64 (n= 6,3,6,30,13) | -10.1 millimeters of mercury (mmHg) | Standard Deviation 13.32 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Change at Day 148 (n= 0,0,0,25,7) | -3.9 millimeters of mercury (mmHg) | Standard Deviation 8.36 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 190 (n= 0,0,0,24,6) | -10 millimeters of mercury (mmHg) | Standard Deviation 16.15 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | DBP: Baseline (n= 7,3,7,33,13) | 83 millimeters of mercury (mmHg) | Standard Deviation 11.17 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Change at Day 22 (n= 6,3,7,33,13) | -8.5 millimeters of mercury (mmHg) | Standard Deviation 19.53 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period | SBP: Baseline (n= 7,3,7,33,13) | 140.1 millimeters of mercury (mmHg) | Standard Deviation 10.85 |
Primary
Changes From Baseline in Weight During the Treatment Period
In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Time frame: From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)
Population: Only participants who received treatment were assessed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Baseline (n= 7,3,7,33,13) | 89.3 kilogram(s) | Standard Deviation 13.15 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | NA kilogram(s) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | NA kilogram(s) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | NA kilogram(s) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | NA kilogram(s) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | -1 kilogram(s) | Standard Deviation 1.95 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | -1.8 kilogram(s) | Standard Deviation 1.31 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | 0.1 kilogram(s) | Standard Deviation 4.2 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | NA kilogram(s) | — |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | NA kilogram(s) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | NA kilogram(s) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Baseline (n= 7,3,7,33,13) | 81.9 kilogram(s) | Standard Deviation 21.66 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | NA kilogram(s) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | -0.3 kilogram(s) | Standard Deviation 1.55 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | NA kilogram(s) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | 0.2 kilogram(s) | Standard Deviation 2.2 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | NA kilogram(s) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | NA kilogram(s) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | NA kilogram(s) | — |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | 0.3 kilogram(s) | Standard Deviation 2.04 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | -1.4 kilogram(s) | Standard Deviation 2.5 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | -1.2 kilogram(s) | Standard Deviation 3.08 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | -1 kilogram(s) | Standard Deviation 2.99 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | NA kilogram(s) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | NA kilogram(s) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | NA kilogram(s) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | NA kilogram(s) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | NA kilogram(s) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Baseline (n= 7,3,7,33,13) | 97.1 kilogram(s) | Standard Deviation 14.29 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Changes From Baseline in Weight During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | NA kilogram(s) | — |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Baseline (n= 7,3,7,33,13) | 87.7 kilogram(s) | Standard Deviation 14.81 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | -0.3 kilogram(s) | Standard Deviation 3.53 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | -0.1 kilogram(s) | Standard Deviation 4.09 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | -0.1 kilogram(s) | Standard Deviation 4.45 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | -0.1 kilogram(s) | Standard Deviation 4.53 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | 0.1 kilogram(s) | Standard Deviation 5 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | -0.4 kilogram(s) | Standard Deviation 1.42 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | 0 kilogram(s) | Standard Deviation 2.2 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | 0.2 kilogram(s) | Standard Deviation 2.41 |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | -0.2 kilogram(s) | Standard Deviation 3.47 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 127 (n= 0,0,0,27,8) | 2.1 kilogram(s) | Standard Deviation 2.11 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 64 (n= 6,3,6,30,13) | 0.3 kilogram(s) | Standard Deviation 2.48 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Baseline (n= 7,3,7,33,13) | 92 kilogram(s) | Standard Deviation 22.28 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 190 (n= 0,0,0,24,6) | -0.7 kilogram(s) | Standard Deviation 3.59 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 169 (n= 0,0,0,25,7) | 1.7 kilogram(s) | Standard Deviation 3.81 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 106 (n= 0,0,0,28,12) | 0.4 kilogram(s) | Standard Deviation 3.1 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 85 (n= 0,0,0,28,13) | 0.4 kilogram(s) | Standard Deviation 2.87 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 148 (n= 0,0,0,25,7) | 1.9 kilogram(s) | Standard Deviation 2.72 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 43 (n= 6,3,7,32,13) | 0.5 kilogram(s) | Standard Deviation 1.98 |
| Docetaxel 75 mg/m^2 - Safety Cohort | Changes From Baseline in Weight During the Treatment Period | Change at Day 22 (n= 6,3,7,33,13) | -0.2 kilogram(s) | Standard Deviation 1.92 |
Primary
Number of Subjects With Dose-Limiting Toxicities - Dose Escalation Part
DLT was defined as - Absolute neutrophil count grade greater than or equal to (\>=) 4 (Common Terminology Criteria for Adverse Events \[CTCAE\], Version 4.0: less than \[\<\] 0.5 × 109 per Liter) lasting longer than 7 days without fever despite granulocyte colony-stimulating factor (G-CSF) support). Platelet count Grade \>= 4 (CTCAE, v4.0: \< 25× 109/L) lasting longer than 7 days. Diarrhea Grade \>= 3 (CTAE, v4.0: increase of \>= 7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared with baseline; limiting self-care in activities of daily living) in spite of optimal use of antidiarrheal medication. Vomiting or constipation Grade \>= 4 (CTCAE, v4.0: life-threatening consequences; urgent intervention indicated). Febrile neutropenia Grade \>= 3 (CTCAE, v4.0).
Time frame: From randomization until 6 weeks post-injection in all dose cohort of dose-escalation part
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Dose-Limiting Toxicities - Dose Escalation Part | 0 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Dose-Limiting Toxicities - Dose Escalation Part | 0 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Dose-Limiting Toxicities - Dose Escalation Part | 0 Participants |
Primary
Number of Subjects With Physical Examination During the Treatment Period
Any physical examination finding that was classified by the investigator as a clinically significant change (compared with previous examination) was considered an AE, documented on the eCRF, and followed until the outcome was known. The below physical examination findings were recorded and reported. GDASC = General disorders and administration site conditions MND = Metabolism and nutrition disorders SSTD= Skin and subcutaneous tissue disorders MCTD = Musculoskeletal and connective tissue disorders IPPC = Injury, poisoning and procedural complications RTMD = Respiratory, thoracic and mediastinal disorders NBMU = Neoplasms benign, malignant and unspecified (include cysts and polyps) In the below table.
Time frame: From start of study treatment to 6 weeks after study treatment (i.e., maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)
Population: Only participants who received treatment were assessed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 64: MND | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: IPPC | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 64: GDASC | 0 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: RTMD | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Social circumstances | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 64: SSTD | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: SSTD | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: NBMU | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: MCTD | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: GDASC | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Gastrointestinal disorders | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Vascular disorders | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 64: GDASC | 0 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Gastrointestinal disorders | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: RTMD | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: GDASC | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Social circumstances | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 64: MND | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: MCTD | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 64: SSTD | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: NBMU | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: SSTD | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Vascular disorders | NA Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: IPPC | NA Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: MCTD | NA Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: IPPC | NA Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: RTMD | NA Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Social circumstances | NA Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Vascular disorders | NA Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: SSTD | NA Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 64: GDASC | 2 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: GDASC | NA Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 64: MND | NA Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: NBMU | NA Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Gastrointestinal disorders | NA Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Physical Examination During the Treatment Period | At day 64: SSTD | NA Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Gastrointestinal disorders | 1 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 64: GDASC | 5 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 64: SSTD | 2 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 64: MND | 0 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: GDASC | 7 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: MCTD | 1 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: SSTD | 7 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Vascular disorders | 0 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: RTMD | 0 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: IPPC | 2 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: NBMU | 2 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Social circumstances | 1 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Vascular disorders | 1 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: SSTD | 2 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 64: SSTD | 6 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: IPPC | 0 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: MCTD | 0 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: GDASC | 2 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Social circumstances | 0 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 64: MND | 1 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 64: GDASC | 2 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: NBMU | 0 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: Gastrointestinal disorders | 1 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Physical Examination During the Treatment Period | At day 190: RTMD | 1 Participants |
Primary
Number of Subjects With Signs of Long-Term Radiation Toxicity
Long-term radiation toxicity included incidence of potential late toxicity, such as new primary cancers and bone marrow changes (acute myelogenous leukemia, myelodysplastic syndrome, and aplastic anemia).
Time frame: From start of study treatment upto 12 months
Population: Only participants who received treatment were assessed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Signs of Long-Term Radiation Toxicity | 2 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Signs of Long-Term Radiation Toxicity | 0 Participants |
Primary
Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4
Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in patient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.
Time frame: From start of study treatment to 6 weeks after study treatment (that is maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort) and 8 weeks for serious AEs
Population: Only participants who received treatment were assessed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TEAE CTCAE Grade 3 | 3 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TESAE | 4 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TEAE CTCAE Grade 4 | 2 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TEAE CTCAE Grade 4 | 1 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TEAE CTCAE Grade 3 | 1 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TESAE | 0 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TEAE CTCAE Grade 4 | 1 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TEAE CTCAE Grade 3 | 4 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TESAE | 2 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TEAE CTCAE Grade 3 | 6 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TESAE | 7 Participants |
| Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TEAE CTCAE Grade 4 | 10 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TEAE CTCAE Grade 4 | 6 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TEAE CTCAE Grade 3 | 3 Participants |
| Docetaxel 75 mg/m^2 - Safety Cohort | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4 | TESAE | 4 Participants |
Other Pre-specified
Exploratory Efficacy: Percent Change From Baseline in Circulating Tumor Cells at Day 85
CTCs were measured to follow the evolution of the level of CTCs after treatment.
Time frame: Baseline, Day 85, expanded safety cohort
Population: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Exploratory Efficacy: Percent Change From Baseline in Circulating Tumor Cells at Day 85 | -75.3 Percent Change | Standard Deviation 55.29 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Exploratory Efficacy: Percent Change From Baseline in Circulating Tumor Cells at Day 85 | -68.4 Percent Change | Standard Deviation 61.4 |
Other Pre-specified
Exploratory Efficacy: Time to Clinical or Radiographic Progression
Time to first radiologic or clinical progression is determined by one of the following: * For soft tissue lesions, the determination is based on Response Evaluation Criteria in Solid Tumors 1.1. * For bone disease, the determination is based on Prostate Cancer Working Cohort 2 (PCWG2) definitions, which require the appearance of at least 2 new lesions with a confirmatory bone scan at least 6 or more weeks later. For clinical progression, the investigators followed the recommendations of the PCWG25 and used their clinical judgment to determine clinical progression.
Time frame: From start of study treatment to 12 months, at every 12 weeks
Population: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Exploratory Efficacy: Time to Clinical or Radiographic Progression | 365 days |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Exploratory Efficacy: Time to Clinical or Radiographic Progression | 284 days |
Other Pre-specified
Exploratory Efficacy: Time to Prostate-specific Antigen (PSA) Progression
Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least 1 week apart.
Time frame: 12 months
Population: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Exploratory Efficacy: Time to Prostate-specific Antigen (PSA) Progression | 200 days |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Exploratory Efficacy: Time to Prostate-specific Antigen (PSA) Progression | 146 days |
Other Pre-specified
Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers
Weighted mean area under the curve for the below bone turnover biomarkers were evaluated, ICTP = pyridinoline cross-linked carboxyterminal telopeptide P1NP = N-terminal peptide of procollagen type 1 uCTX-1 = urine C-telopeptide 1
Time frame: From start of study treatment to 6 weeks after study treatment (maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)
Population: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers | uCTX-1 | 14 mcg/L | Standard Deviation 16.86 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers | P1NP | 42.9 mcg/L | Standard Deviation 42.36 |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers | ICTP | 4.7 mcg/L | Standard Deviation 2.43 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers | uCTX-1 | 22.6 mcg/L | Standard Deviation 28.2 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers | P1NP | 106.5 mcg/L | Standard Deviation 118.93 |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers | ICTP | 7 mcg/L | Standard Deviation 7.08 |
Other Pre-specified
Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain
The subject completed the full BPI (short form) paper questionnaire, and clinical staff completed the analgesic log. The test consists of 10 questions addressing severity, location, chronicity, and amount of relief. In question 3, subjects with pain are asked to evaluate the severity of pain at worst in the past 24 hours in a 0 to 10 scale, with 0 indicating no pain, and 10 indicating the worst pain.
Time frame: From start of study treatment until 12 months
Population: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Safety Follow-up | 18 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 64 | 21 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | 12-Month Follow-up | 7 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 85 | 20 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 1 | 23 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 106 | 20 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 169 | 17 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 127 | 19 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 22 | 24 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 190 | 17 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | 6-Month Follow-up | 1 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 43 | 22 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | 9-Month Follow-up | 12 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 148 | 18 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | 12-Month Follow-up | 5 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 148 | 5 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 169 | 5 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Safety Follow-up | 9 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | 9-Month Follow-up | 7 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 1 | 11 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 22 | 11 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 43 | 10 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 64 | 10 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 85 | 11 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 106 | 9 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 127 | 6 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | Day 190 | 5 Participants |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain | 6-Month Follow-up | 2 Participants |
Other Pre-specified
Overall Survival Rate
The overall survival (OS) time in days was calculated as number of days since the day of first dose of study medication until the date of death.
Time frame: 12 months
Population: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Overall Survival Rate | 89.1 days |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Overall Survival Rate | 90 days |
Other Pre-specified
Progression Free Survival (PFS) End Point
PFS defined as the time from randomization (randomization referred to the date of treatment assignment) to disease progression (radiological or clinical, whichever was earlier) or death (if death occurred before progression was documented). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.
Time frame: From start of study treatment to 12 months, at every 12 weeks
Population: Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation | Progression Free Survival (PFS) End Point | 189 days |
| Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation | Progression Free Survival (PFS) End Point | 146 days |