Malignant Solid Tumor
Conditions
Keywords
Open Label multicenter extension study advanced solid tumors
Brief summary
The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in a NKTR-102 study who are without signs of disease progression since receiving NKTR-102. In addition the study will evaluate the safety of continued exposure to NKTR-102, observe disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.
Interventions
DRUGNKTR-102 145 mg/m2
A 90 minute IV infusion of 145 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
DRUGNKTR-102 120 mg/m2
A 90 minute IV infusion of 120 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
DRUGNKTR-102 95 mg/m2
A 90 minute IV infusion of 95 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
DRUGNKTR-102 50 mg/m2
A 90 minute IV infusion of 50 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
Sponsors
Nektar Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: 1. Received prior treatment with NKTR-102 2. Free of disease progression since receiving NKTR-102 3. Adequate bone marrow and organ function 4. Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt of their of last dose of NKTR-102 5. Agree to use adequate contraception Exclusion: 1. Treatment with other anti-cancer therapy between the last dose of NKTR-102 in the prior study and before first dose of NKTR-102 in the extension study 2. A toxicity that requires a 3rd dose reduction after taking NKTR-102 or are scheduled to receive a dose \< 70 mg/m2 upon entry into this study 3. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Exposure to NKTR-102 | Screening, Every 21 day cycle of treatment and Quarterly Follow-up | To provide access to NKTR-102 to subjects who previously received NKTR-102 in a clinical trial and were without signs of disease progression since receiving NKTR-102. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Screening, Every 21 day cycle of treatment and Quarterly Follow-up | To evaluate the safety of continued exposure to NKTR-102. |
| Disease Status | Screening, Every 21 day cycle of treatment and Quarterly Follow-up | To observe disease status and survival status in subjects receiving NKTR-102. |
| Efficacy of NKTR-102 | Screening, Every 21 day cycle of treatment and Quarterly Follow-up | To evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors. |
Countries
Belgium, United States
Participant flow
Pre-assignment details
Subjects were assessed for eligibility following completion of NKTR-102 treatment on a prior NKTR-102 clinical study. The trials from which the subjects were previously enrolled in are listed below. NCT00856375 - 1 patient NCT00806156 - 1 patient NCT01492101 - 1 patient NCT00802945 - 2 patients NCT01976143 - 10 patients NCT01991678 - 12 patients
Participants by arm
| Arm | Count |
|---|---|
| 145 mg/m2 NKTR-102: A 90 minute IV infusion of 145 mg/m2 | 20 |
| 120 mg/m2 NKTR-102: A 90 minute IV infusion of 120 mg/m2 | 4 |
| 95 mg/m2 NKTR-102: A 90 minute IV infusion of 95 mg/m2 | 1 |
| 50 mg/m2 NKTR-102: A 90 minute IV infusion of 50 mg/m2 | 2 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 1 |
| Overall Study | Clinical Progression | 0 | 1 | 0 | 1 |
| Overall Study | Physician Decision | 2 | 0 | 0 | 0 |
| Overall Study | Progressive Disease by RECIST | 12 | 3 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 145 mg/m2 | 120 mg/m2 | 95 mg/m2 | 50 mg/m2 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 9.92 | 63.0 years STANDARD_DEVIATION 9.98 | 44.0 years | 53.5 years STANDARD_DEVIATION 3.54 | 56.0 years STANDARD_DEVIATION 10.01 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 3 Participants | 1 Participants | 0 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Primary Tumor Diagnosis Breast | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants |
| Primary Tumor Diagnosis Colorectal | 8 Participants | 2 Participants | 0 Participants | 0 Participants | 10 Participants |
| Primary Tumor Diagnosis Liver | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Primary Tumor Diagnosis Lung | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Primary Tumor Diagnosis Other | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Primary Tumor Diagnosis Ovary | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Primary Tumor Diagnosis Pancreas | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 14 Participants | 4 Participants | 0 Participants | 2 Participants | 20 Participants |
| Sex: Female, Male Female | 13 Participants | 2 Participants | 1 Participants | 1 Participants | 17 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 0 Participants | 1 Participants | 10 Participants |
| Stage at Original NKTR-102 Study Enrollment I | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 5 Participants |
| Stage at Original NKTR-102 Study Enrollment II | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Stage at Original NKTR-102 Study Enrollment IIA | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Stage at Original NKTR-102 Study Enrollment III | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Stage at Original NKTR-102 Study Enrollment IV | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants |
| Stage at Original NKTR-102 Study Enrollment Unknown | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Time Since Initial Diagnosis to Original NKTR-102 Study | 5.936 years STANDARD_DEVIATION 5.3536 | 5.040 years STANDARD_DEVIATION 1.2142 | 15.780 years | 3.450 years STANDARD_DEVIATION 0.0707 | 5.984 years STANDARD_DEVIATION 5.0437 |
| Time Since Metastatic Diagnosis to Original NKTR-102 Study | 3.666 days STANDARD_DEVIATION 2.3677 | 2.733 days STANDARD_DEVIATION 1.3546 | 3.660 days | 0.000 days | 3.357 days STANDARD_DEVIATION 2.2403 |
| Treatment Duration in Original NKTR-102 Study | 56.6 days STANDARD_DEVIATION 125.67 | 141.5 days STANDARD_DEVIATION 179.04 | 1008.0 days | 21.0 days STANDARD_DEVIATION 0 | 101.7 days STANDARD_DEVIATION 221.68 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 16 / 20 | 3 / 4 | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 20 / 20 | 4 / 4 | 1 / 1 | 2 / 2 |
| serious Total, serious adverse events | 5 / 20 | 1 / 4 | 0 / 1 | 1 / 2 |
Outcome results
Primary
Length of Exposure to NKTR-102
To provide access to NKTR-102 to subjects who previously received NKTR-102 in a clinical trial and were without signs of disease progression since receiving NKTR-102.
Time frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 145 mg/m2 | Length of Exposure to NKTR-102 | 139.0 days | Standard Deviation 126.19 |
| 120 mg/m2 | Length of Exposure to NKTR-102 | 33.0 days | Standard Deviation 14.07 |
| 95 mg/m2 | Length of Exposure to NKTR-102 | 126.0 days | — |
| 50 mg/m2 | Length of Exposure to NKTR-102 | 21.0 days | Standard Deviation 0 |
Secondary
Adverse Events
To evaluate the safety of continued exposure to NKTR-102.
Time frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 145 mg/m2 | Adverse Events | # of Subjects with Neutrophil Count Decreased | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Herpex Simplex Encephalitis | 0 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Vomiting | 4 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Insomnia | 0 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Gingival Infection | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Abdominal Infection | 0 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Constipation | 4 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Pruritus | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Influenza | 0 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Gastroenteritis | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Abdominal Pain | 2 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Dsypnoea | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Urinary Tract Infections | 3 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Pyrexia | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Dyspepsia | 2 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Weight Decreased | 5 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Non-Cardiac Chest Pain | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Oedema Peripheral | 2 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Upper Abdominal Pain | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Depressed Mood | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Fatigue | 6 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Stomatitis | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Ascites | 0 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Hypoaesthsia | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Dyasgeusia | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Mouth Ulceration | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Hypoaesthesia Oral | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Dry Mouth | 0 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Alopecia | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Productive Cough | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Aphonia | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Cancer Pain | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Hypotension | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Rash | 2 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Appendix Cancer | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Musculoskeletal Pain | 0 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Pelvic Venous Thrombosis | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with hyponatremia | 2 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Muscular Weakness | 0 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Flank Pain | 1 # of events |
| 145 mg/m2 | Adverse Events | Number of Subjects with at least one TEAE | 20 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Pneumothorax | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Back Pain | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Hypophosphatemia | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Peritonitis Bacterial | 0 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Cough | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Hypomagnesemia | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Hypocalcemia | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Anemia | 3 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Oropharyngeal Pain | 2 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Hyperglycemia | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with dehydration | 0 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Neutropenia | 3 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Pulmonary Embolism | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with hypoglycemia | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with hypokalemia | 2 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Leukopenia | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Hypoxis | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with hypoalbuminemia | 3 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with decreased appetite | 4 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Tachycardia | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Vaginal Hemorrhage | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Prothrombin time prolonged | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Liver Function Test abnormal | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Vision Blurred | 3 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Renal Failure Acute | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Blood creatine increased | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Blood bilirubin increased | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Photophobia | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Decubitus Ulcer | 2 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Alanine Aminotransferase Increased | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Activated partial thromboplastin time prolonged | 0 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Diarrhea | 11 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Epistaxis | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with White blood cell count decreased | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Aspartate Aminostransferase | 1 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Nausea | 6 # of events |
| 145 mg/m2 | Adverse Events | # of Subjects with Proteinuria | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Depressed Mood | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with hyponatremia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Pneumothorax | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Rash | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Productive Cough | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Pulmonary Embolism | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Decubitus Ulcer | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Pruritus | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Alopecia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Hypotension | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Pelvic Venous Thrombosis | 0 # of events |
| 120 mg/m2 | Adverse Events | Number of Subjects with at least one TEAE | 4 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Peritonitis Bacterial | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Anemia | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Neutropenia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Leukopenia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Tachycardia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Vision Blurred | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Photophobia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Diarrhea | 3 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Nausea | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Vomiting | 2 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Constipation | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Abdominal Pain | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Dyspepsia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Upper Abdominal Pain | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Pyrexia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Ascites | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Dry Mouth | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Hypoaesthesia Oral | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Mouth Ulceration | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Stomatitis | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Fatigue | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Oedema Peripheral | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Non-Cardiac Chest Pain | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Urinary Tract Infections | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Gastroenteritis | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Influenza | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Abdominal Infection | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Gingival Infection | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Herpex Simplex Encephalitis | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Weight Decreased | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Neutrophil Count Decreased | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Aspartate Aminostransferase | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with White blood cell count decreased | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Activated partial thromboplastin time prolonged | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Alanine Aminotransferase Increased | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Blood bilirubin increased | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Blood creatine increased | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Liver Function Test abnormal | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Prothrombin time prolonged | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with decreased appetite | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with hypoalbuminemia | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with hypokalemia | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with hypoglycemia | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with dehydration | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Hyperglycemia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Hypocalcemia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Hypomagnesemia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Hypophosphatemia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Back Pain | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Flank Pain | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Muscular Weakness | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Musculoskeletal Pain | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Appendix Cancer | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Cancer Pain | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Aphonia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Dyasgeusia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Hypoaesthsia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Insomnia | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Proteinuria | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Renal Failure Acute | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Vaginal Hemorrhage | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Oropharyngeal Pain | 1 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Cough | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Dsypnoea | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Epistaxis | 0 # of events |
| 120 mg/m2 | Adverse Events | # of Subjects with Hypoxis | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Epistaxis | 0 # of events |
| 95 mg/m2 | Adverse Events | Number of Subjects with at least one TEAE | 1 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Prothrombin time prolonged | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Back Pain | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Activated partial thromboplastin time prolonged | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Herpex Simplex Encephalitis | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Productive Cough | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Flank Pain | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Renal Failure Acute | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Pelvic Venous Thrombosis | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with hypoglycemia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Muscular Weakness | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with decreased appetite | 1 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Photophobia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Cough | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Musculoskeletal Pain | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Leukopenia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Hypotension | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Insomnia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Appendix Cancer | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with hypoalbuminemia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Alanine Aminotransferase Increased | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Aspartate Aminostransferase | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Cancer Pain | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Pulmonary Embolism | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Alopecia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Hypoxis | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Aphonia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with hypokalemia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Dry Mouth | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Nausea | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Neutropenia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Proteinuria | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Hypoaesthesia Oral | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with hyponatremia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Ascites | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Dsypnoea | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Mouth Ulceration | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Blood bilirubin increased | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Diarrhea | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Dyasgeusia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Stomatitis | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Vaginal Hemorrhage | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Upper Abdominal Pain | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with dehydration | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Fatigue | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Vision Blurred | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Anemia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Rash | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Oedema Peripheral | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Pneumothorax | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Dyspepsia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Hyperglycemia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Non-Cardiac Chest Pain | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Blood creatine increased | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with White blood cell count decreased | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Pyrexia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Neutrophil Count Decreased | 1 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Abdominal Pain | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Hypoaesthsia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Urinary Tract Infections | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Hypocalcemia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Weight Decreased | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Peritonitis Bacterial | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Gastroenteritis | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Liver Function Test abnormal | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Constipation | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Hypomagnesemia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Influenza | 1 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Decubitus Ulcer | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Tachycardia | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Pruritus | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Abdominal Infection | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Oropharyngeal Pain | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Vomiting | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Depressed Mood | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Gingival Infection | 0 # of events |
| 95 mg/m2 | Adverse Events | # of Subjects with Hypophosphatemia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Gingival Infection | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Depressed Mood | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Herpex Simplex Encephalitis | 1 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Decubitus Ulcer | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Weight Decreased | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Neutrophil Count Decreased | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Diarrhea | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Aspartate Aminostransferase | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Insomnia | 1 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with White blood cell count decreased | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Photophobia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Activated partial thromboplastin time prolonged | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Hypoxis | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Alanine Aminotransferase Increased | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Vision Blurred | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Blood bilirubin increased | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Proteinuria | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Blood creatine increased | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Tachycardia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Pulmonary Embolism | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Liver Function Test abnormal | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Prothrombin time prolonged | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Leukopenia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with decreased appetite | 1 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Renal Failure Acute | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with hypoalbuminemia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Neutropenia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with hypokalemia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Epistaxis | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with hyponatremia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Anemia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with dehydration | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Vaginal Hemorrhage | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Hyperglycemia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Peritonitis Bacterial | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Productive Cough | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Hypocalcemia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with hypoglycemia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Hypomagnesemia | 0 # of events |
| 50 mg/m2 | Adverse Events | Number of Subjects with at least one TEAE | 2 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Hypophosphatemia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Oropharyngeal Pain | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Back Pain | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Pelvic Venous Thrombosis | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Flank Pain | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Muscular Weakness | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Hypotension | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Musculoskeletal Pain | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Cough | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Appendix Cancer | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Alopecia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Pneumothorax | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Cancer Pain | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Aphonia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Dry Mouth | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Ascites | 1 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Rash | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Hypoaesthesia Oral | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Mouth Ulceration | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Upper Abdominal Pain | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Stomatitis | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Dyasgeusia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Fatigue | 1 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Dyspepsia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Oedema Peripheral | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Dsypnoea | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Non-Cardiac Chest Pain | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Abdominal Pain | 1 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Pyrexia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Urinary Tract Infections | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Constipation | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Hypoaesthsia | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Gastroenteritis | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Pruritus | 1 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Influenza | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Vomiting | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Abdominal Infection | 0 # of events |
| 50 mg/m2 | Adverse Events | # of Subjects with Nausea | 0 # of events |
Secondary
Disease Status
To observe disease status and survival status in subjects receiving NKTR-102.
Time frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Population: Four participants including the one in Group 4 had to discontinue treatment prior to measuring this outcome
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 145 mg/m2 | Disease Status | Stable Disease (SD) | 10 Participants |
| 145 mg/m2 | Disease Status | Progressive Disease (PD) | 8 Participants |
| 120 mg/m2 | Disease Status | Progressive Disease (PD) | 3 Participants |
| 120 mg/m2 | Disease Status | Stable Disease (SD) | 1 Participants |
| 95 mg/m2 | Disease Status | Stable Disease (SD) | 0 Participants |
| 95 mg/m2 | Disease Status | Progressive Disease (PD) | 1 Participants |
| 50 mg/m2 | Disease Status | Stable Disease (SD) | 0 Participants |
| 50 mg/m2 | Disease Status | Progressive Disease (PD) | 0 Participants |
Secondary
Efficacy of NKTR-102
To evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.
Time frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Population: Four participants including the one in Group 4 had to discontinue treatment prior to this outcome being measured.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 145 mg/m2 | Efficacy of NKTR-102 | # of Participants who achieved Complete Response (CR) | 0 participants |
| 145 mg/m2 | Efficacy of NKTR-102 | # of Participants who achieved Partial Response (PR) | 0 participants |
| 120 mg/m2 | Efficacy of NKTR-102 | # of Participants who achieved Complete Response (CR) | 0 participants |
| 120 mg/m2 | Efficacy of NKTR-102 | # of Participants who achieved Partial Response (PR) | 0 participants |
| 95 mg/m2 | Efficacy of NKTR-102 | # of Participants who achieved Complete Response (CR) | 0 participants |
| 95 mg/m2 | Efficacy of NKTR-102 | # of Participants who achieved Partial Response (PR) | 0 participants |