Colorectal Cancer Metastatic, Pancreatic Adenocarcinoma Metastatic, Pancreatic Adenocarcinoma Non-resectable
Conditions
Keywords
macrobead, biological, mouse cells
Brief summary
This is a clinical research study of an investigational (FDA BB-IND 10091) treatment for patients with pancreatic cancer (all stages) and advanced colorectal cancer that no longer responds to standard therapies. The treatment is being evaluated for its effect on tumor growth. It consists of the placement (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA macrobeads). The cells in the macrobeads produce substances that have been shown to slow or stop the growth of tumors in experimental animals and veterinary patients. It has been tested in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II studies in patients with colorectal, pancreatic or prostate cancers are in progress.
Detailed description
This is an open-label Phase 2 clinical trial. The study will have a duration of 12 months and involve a potential total of four macrobead implants for each enrolled patient, with the implants being no less than three months apart. The RENCA macrobeads are implanted intraperitoneally, using laparoscopic surgical procedures. The macrobeads remain permanently within the peritoneal cavity, even if patients withdraw from the study and/or begin new therapy (e.g. chemotherapy). After the formal phase of the trial is completed, subjects will be followed for life. The intent of this Phase 2 trial is to assess efficacy, safety, and tolerability of RENCA macrobeads. Screening occurs within 28 days prior to first implantation. Enrolled patients are treated with a dose of 8 RENCA macrobeads per kilogram of body weight and observed for a minimum of 3 months prior to the next implantation. A maximum of 4 implantation procedures is possible. Day 0 is the day of implantation. Prior to the start of the study, the Investigators ensured that the protocol and any attendant documentation were approved, in writing, by the Institutional Review Board. The study was conducted in compliance with the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice Guidelines (E6 \[R1\]) for conducting, recording, and reporting studies, as well as for archiving essential documents. The Investigators, the Medical Monitor of the sponsor, and the Data Safety Monitoring Board were responsible for monitoring safety parameters collected in the study. They, collectively, provided oversight and monitoring of the safety of the participants in the study.
Interventions
BIOLOGICALRENCA macrobeads
Sponsors
Vital Systems Inc.
The Rogosin Institute
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
* Histologically confirmed adenocarcinoma of the pancreas, colon or rectum. * Radiographic evidence of metastatic cancer of the colon or rectum. * Pancreatic cancer that is unresectable or already metastatic, or colorectal cancer that has failed available approved treatment modalities. * For pancreatic cancer patients, prior chemotherapy is not required; for colon and rectal cancer patients must have failed available chemotherapy/targeted regimens. There were no limits to the number of prior chemotherapeutic regimens. * The patient had evidence of progressive disease defined as at least one of the following: 1. Progressive measurable disease using conventional solid tumor criteria. 2. Increasing tumor markers and/or activity on positron emission tomography / standard uptake value (PET/SUV) measurement. * All clinically significant toxic effects (excluding alopecia) of prior surgery, radiotherapy, or hormonal therapy were resolved to ≤ Grade 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v.3.0) with the exception of neuropathy, which was resolved to ≤ Grade 2. * Performance status (ECOG PS) 0-2. * Adequate hematologic function, minimum requirements: 1. absolute neutrophil count (ANC) ≥ 1500/mL 2. hemoglobin ≥ 9 g/dL 3. platelets ≥ 100,000/mL * Adequate hepatic function, defined as follows: 1. bilirubin ≤ 1.5 times the upper limit of normal (ULN) 2. aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times the ULN, or ≤ 5 times the ULN if liver metastases are present * Adequate renal function, defined as serum creatinine ≤ 2.0 mg/dL. * Adequate coagulation function, defined as follows: 1. an international normalized ratio (INR) ≤ 1.5 2. a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN, unless on anti-coagulant therapy 3. patients receiving full-dose anticoagulation therapy were eligible provided they met all other criteria, were on a stable dose or anticoagulant therapy or low molecular weight heparin (and if on warfarin had a therapeutic INR between 2-3) * Life expectancy of at least 6 weeks. * For females of childbearing potential, a negative pregnancy test. * Agrees to contraceptive use (barrier method) while on study, if sexually active. * Provided signed informed consent.
Exclusion criteria
* Any condition presenting an unacceptably high anesthetic or surgical risk, based on current anesthesia/general surgery standards. * Positive test for HIV, hepatitis B, C, or E. * Cognitive impairment such as to preclude informed consent. * Hypersensitivity reaction that, in the opinion of the investigators posed an increased risk of an allergy to the macrobeads, particularly any known allergy to murine antigens or body tissues. * Surgical treatment or chemotherapy within three weeks of scheduled macrobead implantation or within four weeks of bevacizumab (or similar drugs), or radiation therapy within four weeks of scheduled macrobead implantation. * Investigational medication(s)/therapies for respective tumor within one month of baseline evaluation. * Inadequate hematologic function, defined as follows: 1. ANC \< 1500/mL 2. hemoglobin \< 9 g/dL 3. platelets \< 100,000/mL * Inadequate hepatic function, defined as follows: 1. bilirubin \> 1.5 times the ULN 2. AST and ALT \> 3 times the ULN or \> 5 times the ULN, if liver metastases present * Inadequate renal function, defined as serum creatinine \> 2.0 mg/dL. * Inadequate coagulation function, defined as follows: 1. INR \> 1.5 2. PTT \> 5 seconds (unless on anti-coagulant therapy) * Hepatic blood flow abnormalities, portal vein hypertension and thrombosis, and/or large-volume ascites. * Concurrent cancer of any other type except skin cancer (excluding melanoma). * Ongoing or active infection, congestive heart failure, unstable angina, serious cardiac arrhythmias, psychiatric illness, difficult social situations not permitting reliable participation, active bleeding. * As a result of the medical history, examination, or blood testing, the investigator considers the patient unfit for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival - Based on Most Recent Scan | From date of the most recent scan (disease progression) prior to the first macrobead implantation; assessed up to 32 months. | The primary efficacy outcome is post-implantation all-cause mortality, where time to death is defined as the time from the most recent scan prior to first implantation (time of origin, To) to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival - Based on 1st Implant | From date of the first RENCA macrobead implant; assessed up to 32 months. | The secondary efficacy objective was to evaluate overall survival calculated using the time from first RENCA macrobead implantation to death from any cause. |
| Overall Survival - Based on Stage IV Disease Diagnosis | From date of Stage IV disease diagnosis up to 126 months; up to 32 months from first RENCA macrobead implant. | The secondary efficacy objective was to evaluate overall survival calculated using the time from Stage IV disease diagnosis to death from any cause. |
Other
| Measure | Time frame | Description |
|---|---|---|
| C-reactive Protein Levels in mCRC Participants | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). | C-reactive protein (CRP) is one of three inflammatory markers assessed during this study. CRP levels were assessed as a marker of systemic inflammatory processes. |
| C-Reactive Protein Levels in Pancreatic Cancer Participants | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). | C-reactive protein (CRP) is one of three inflammatory markers assessed during this study. CRP levels were assessed as a marker of systemic inflammatory processes. |
| Erythrocyte Sedimentation Rate in mCRC Participants | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). | Erythrocyte sedimentation rate (ESR) is one of three inflammatory markers assessed during this study. ESR was assessed as a marker of systemic inflammatory processes. |
| Erythrocyte Sedimentation Rate in Pancreatic Cancer Participants | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). | Erythrocyte sedimentation rate (ESR) is one of three inflammatory markers assessed during this study. ESR was assessed as a marker of systemic inflammatory processes. |
| Cancer Antigen 125 Levels in mCRC Participants | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). | Cancer Antigen 125 (CA 125) is one of three inflammatory markers assessed during this study. CA 125 was used to monitor more localized intra-abdominal/peritoneal inflammatory processes related to the placement of the RENCA macrobeads or, in some cases, the intraperitoneal spread of tumor. |
| Cancer Antigen 125 Levels in Pancreatic Cancer Participants | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). | Cancer Antigen 125 (CA 125) is one of three inflammatory markers assessed during this study. CA 125 was used to monitor more localized intra-abdominal/peritoneal inflammatory processes related to the placement of the RENCA macrobeads or, in some cases, the intraperitoneal spread of tumor. |
| Performance Status (ECOG Score) of mCRC Participants | Baseline; Day 14, 30, 60 post-Implant; Day 14, 30, 60 post-Implant 2 | The Eastern Cooperative Oncology Group (ECOG) performance scale is a 5-point scale, where 0 denotes perfect health and 5 is death. It is used by clinicians to assess disease progression and how the disease is affecting the daily living abilities of the patient. The ECOG Performance Status scores are defined as follows: 0: Fully active, able to carry on all pre-disease activities without restriction. 1. Restricted in physical strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g. light house work, office work). 2. Ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair 50% or more of waking hours. 4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair. 5. Death |
| Performance Status (ECOG Score) of Pancreatic Cancer Participants | Baseline; Day 14, 30, 60 post-Implant; Day 14, 30, 60 post-Implant 2 | The Eastern Cooperative Oncology Group (ECOG) performance scale is a 5-point scale, where 0 denotes perfect health and 5 is death. It is used by clinicians to assess disease progression and how the disease is affecting the daily living abilities of the patient. The ECOG Performance Status scores are defined as follows: 0: Fully active, able to carry on all pre-disease activities without restriction. 1. Restricted in physical strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g. light house work, office work). 2. Ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair 50% or more of waking hours. 4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair. 5. Death |
| Activities of Daily Living (KPS Score) of mCRC Participants | Baseline; Day 14, 30, 60 Post-Implant 1; Day 14, 30, 60 post-Implant 2 | Karnofsky Performance Status (KPS) is a self-rated scale that measures the participant's ability to perform daily functions, ranging from 0 (dead) to 100 (normal, no complaints, no evidence of disease). Karnofsky scores are defined as follows: 100: Normal; no complaints; no evidence of disease 90: Able to carry on normal activity with effort, minor sign or symptoms of disease 80: Normal activity with effort; some sign or symptoms of disease 70: Cares for self; unable to carry on normal activity or do active work 60: Requires occasional assistance, but is able to care for most personal needs 50: Requires considerable assistance and frequent medical care 40: Disabled; requires special care and assistance 30: Severely disabled; hospitalization is indicated, although death is not imminent 20: Very sick; hospitalization/active support treatment is necessary 10: Moribund; fatal processes progressively worsening 0: Dead |
| Activities of Daily Living (KPS Score) for Pancreatic Cancer Participants | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 | Karnofsky Performance Status (KPS) is a self-rated scale that measures the participant's ability to perform daily functions, ranging from 0 (dead) to 100 (normal, no complaints, no evidence of disease). Karnofsky scores are defined as follows: 100: Normal; no complaints; no evidence of disease 90: Able to carry on normal activity with effort, minor sign or symptoms of disease 80: Normal activity with effort; some sign or symptoms of disease 70: Cares for self; unable to carry on normal activity or do active work 60: Requires occasional assistance, but is able to care for most personal needs 50: Requires considerable assistance and frequent medical care 40: Disabled; requires special care and assistance 30: Severely disabled; hospitalization is indicated, although death is not imminent 20: Very sick; hospitalization/active support treatment is necessary 10: Moribund; fatal processes progressively worsening 0: Dead |
| Global Health Status of mCRC Participants | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales, three symptom scales, a global health status score, and six single items. The Global Health Status is assessed from 2 of the 30 questions (Question 29 and 30), whose response score ranges on a 7 point scale. The score for physical function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor) and the maximum value is 100 (best outcome, excellent). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome. |
| Global Health Status of Pancreatic Cancer Participants | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales, three symptom scales, a global health status score, and six single items. The Global Health Status is assessed from 2 of the 30 questions (Question 29 and 30), whose response score ranges on a 7 point scale. The score for physical function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor) and the maximum value is 100 (best outcome, excellent). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome. |
| Necrosis Comparison of Tumors Using PET-CT Scan | Baseline vs. Day 90 post-Implant 1 | Tumors were assessed by positron emission tomography (PET)-CT scan at baseline and day 90 following the first RENCA macrobead implantation. The use of \[13\]F-fluorodeoxyglucose (FDG) uptake for the detection of lesions \>1 cm in diameter allowed evaluation of metabolic activity. Decreases in FDG uptake were indicative of metabolic suppression of the tumor. The use of PET-CT scanning indicated anatomical localization, approximate size/volume of primary tumor and metastatic lesion(s), and assessment of metabolic activity of the tumor (as an indicator of metabolic health and necrosis). Disease state is reported as a function of Tumor measurement divided by SUVmax. Changes were assessed between day 90 post RENCA macrobead implant and baseline values. Patients with no change = stable; patients with decreased values = decreased/necrosis, and patients with increased values = increased. |
| Physical Function of Pancreatic Cancer Participants | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including physical function), three symptom scales, a global health status score, and six single items. Physical Function is assessed from 5 of the 30 questions (Questions 1-5), whose response score ranges on a 4 point scale. The score for physical function is calculated based on the average score from these 5 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome. |
| Role Function of mCRC Participants | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including role function), three symptom scales, a global health status score, and six single items. Role Function is assessed from 2 of the 30 questions (Questions 6 and 7), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome. |
| Role Function of Pancreatic Cancer Participants | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including role function), three symptom scales, a global health status score, and six single items. Role Function is assessed from 2 of the 30 questions (Questions 6 and 7), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome. |
| Emotional Function of mCRC Participants | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including emotional function), three symptom scales, a global health status score, and six single items. Emotional Function is assessed from 4 of the 30 questions (Questions 21-24), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 4 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome. |
| Emotional Function of Pancreatic Cancer Participants | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including emotional function), three symptom scales, a global health status score, and six single items. Emotional Function is assessed from 4 of the 30 questions (Questions 21-24), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 4 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome. |
| Cognitive Function of mCRC Participants | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including cognitive function), three symptom scales, a global health status score, and six single items. Cognitive Function is assessed from 2 of the 30 questions (Question 20 and 25), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome. |
| Cognitive Function of Pancreatic Cancer Participants | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including cognitive function), three symptom scales, a global health status score, and six single items. Cognitive Function is assessed from 2 of the 30 questions (Question 20 and 25), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome. |
| Social Function of mCRC Participants | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including social function), three symptom scales, a global health status score, and six single items. Social Function is assessed from 2 of the 30 questions (Question 26 and 27), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome. |
| Social Function of Pancreatic Cancer Participants | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including social function), three symptom scales, a global health status score, and six single items. Social Function is assessed from 2 of the 30 questions (Question 26 and 27), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome. |
| Pain Assessment of mCRC Participants | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 | Participants were asked to rate their pain on a discrete scale (from 0 = no pain to 10 worst pain imaginable, unbearable). The worst pain at each time point was used in the analysis. |
| Pain Assessment of Pancreatic Cancer Participants | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 | Participants were asked to rate their pain on a discrete scale (from 0 = no pain to 10 worst pain imaginable, unbearable). The worst pain at each time point was used in the analysis. |
| Physical Function of mCRC Participants | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including physical function), three symptom scales, a global health status score, and six single items. Physical Function is assessed from 5 of the 30 questions (Questions 1-5), whose response score ranges on a 4 point scale. The score for physical function is calculated based on the average score from these 5 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome. |
| Tumor Marker Response of mCRC Participants | Change from baseline up to and including day 30 post-Implant 1 | Tumor markers included serum carcinoembryonic antigen (CEA) and cancer antigen 19-9 (CA 19-9), and were assessed on all participants with mCRC at baseline and at subsequent evaluation points to further assess tumor response to RENCA macrobead implantation. A tumor marker response was defined as a greater than or equal to 20% decrease in one or both of CEA or CA 19-9. |
| Tumor Marker Response of Pancreatic Cancer Participants | Change from baseline up to and including day 30 post-Implant 1. | Tumor markers included serum carcinoembryonic antigen (CEA) and cancer antigen 19-9 (CA 19-9), and were assessed on all participants with pancreatic cancer at baseline and at subsequent evaluation points to further assess tumor response to RENCA macrobead implantation. A tumor marker response was defined as a greater than or equal to 20% decrease in one or both of CEA or CA 19-9. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited based on physician referral between April 2010 and February 2016. The first participant was implanted on April 15, 2010 (pancreatic) and May 14, 2010 (mCRC). The last implantation was on March 4, 2016 (pancreatic) and October 18, 2013 (mCRC).
Pre-assignment details
90 participants provided informed consent to participate in the study (Pancreatic cancer n=34; mCRC n=46). Of these, 24 pancreatic cancer patients and 34 mCRC patients were enrolled in the study. The 22 patients who were not enrolled into the study, after providing consent, had failed the respective eligibility criteria (n=19) or decided not to enroll in the study (n=3).
Participants by arm
| Arm | Count |
|---|---|
| Pancreatic Cancer Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight.
RENCA Macrobeads. | 24 |
| Metastatic Colorectal Cancer Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight.
RENCA macrobeads | 34 |
| Total | 58 |
Baseline characteristics
| Characteristic | Pancreatic Cancer | Metastatic Colorectal Cancer | Total |
|---|---|---|---|
| Age, Continuous | 60.25 years STANDARD_DEVIATION 12.37 | 58.00 years STANDARD_DEVIATION 10.11 | 58.93 years STANDARD_DEVIATION 11.05 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 22 Participants | 27 Participants | 49 Participants |
| Sex: Female, Male Female | 8 Participants | 23 Participants | 31 Participants |
| Sex: Female, Male Male | 16 Participants | 11 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 34 / 34 | 24 / 24 |
| other Total, other adverse events | 34 / 34 | 24 / 24 |
| serious Total, serious adverse events | 31 / 34 | 20 / 24 |
Outcome results
Primary
Overall Survival - Based on Most Recent Scan
The primary efficacy outcome is post-implantation all-cause mortality, where time to death is defined as the time from the most recent scan prior to first implantation (time of origin, To) to death from any cause.
Time frame: From date of the most recent scan (disease progression) prior to the first macrobead implantation; assessed up to 32 months.
Population: Participants who received at least one RENCA macrobead implant.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pancreatic Cancer | Overall Survival - Based on Most Recent Scan | 4.66 months |
| Metastatic Colorectal Cancer | Overall Survival - Based on Most Recent Scan | 7.7 months |
Secondary
Overall Survival - Based on 1st Implant
The secondary efficacy objective was to evaluate overall survival calculated using the time from first RENCA macrobead implantation to death from any cause.
Time frame: From date of the first RENCA macrobead implant; assessed up to 32 months.
Population: Participants who received at least one RENCA macrobead implant.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pancreatic Cancer | Overall Survival - Based on 1st Implant | 4.3 months |
| Metastatic Colorectal Cancer | Overall Survival - Based on 1st Implant | 7.3 months |
Secondary
Overall Survival - Based on Stage IV Disease Diagnosis
The secondary efficacy objective was to evaluate overall survival calculated using the time from Stage IV disease diagnosis to death from any cause.
Time frame: From date of Stage IV disease diagnosis up to 126 months; up to 32 months from first RENCA macrobead implant.
Population: Participants who received at least one RENCA macrobead implant.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pancreatic Cancer | Overall Survival - Based on Stage IV Disease Diagnosis | 15.7 months |
| Metastatic Colorectal Cancer | Overall Survival - Based on Stage IV Disease Diagnosis | 32.1 months |
Other Pre-specified
Activities of Daily Living (KPS Score) for Pancreatic Cancer Participants
Karnofsky Performance Status (KPS) is a self-rated scale that measures the participant's ability to perform daily functions, ranging from 0 (dead) to 100 (normal, no complaints, no evidence of disease). Karnofsky scores are defined as follows: 100: Normal; no complaints; no evidence of disease 90: Able to carry on normal activity with effort, minor sign or symptoms of disease 80: Normal activity with effort; some sign or symptoms of disease 70: Cares for self; unable to carry on normal activity or do active work 60: Requires occasional assistance, but is able to care for most personal needs 50: Requires considerable assistance and frequent medical care 40: Disabled; requires special care and assistance 30: Severely disabled; hospitalization is indicated, although death is not imminent 20: Very sick; hospitalization/active support treatment is necessary 10: Moribund; fatal processes progressively worsening 0: Dead
Time frame: Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2
Population: Implant 1 (Days 0-60): Pancreatic cancer participants who had received at least 1 macrobead implantation and were screened as indicated; Implant 2 (Days 0-60): Pancreatic cancer participants who had received at least 2 macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Activities of Daily Living (KPS Score) for Pancreatic Cancer Participants | 87.9 score on a scale | Standard Deviation 9.3 |
| Metastatic Colorectal Cancer | Activities of Daily Living (KPS Score) for Pancreatic Cancer Participants | 79.5 score on a scale | Standard Deviation 9.7 |
| Increased | Activities of Daily Living (KPS Score) for Pancreatic Cancer Participants | 78.6 score on a scale | Standard Deviation 12.9 |
| mCRC: Non-responder | Activities of Daily Living (KPS Score) for Pancreatic Cancer Participants | 78.6 score on a scale | Standard Deviation 13.8 |
| Implant 2: Day 0 | Activities of Daily Living (KPS Score) for Pancreatic Cancer Participants | 83.3 score on a scale | Standard Deviation 5.8 |
| Implant 2: Day 14 | Activities of Daily Living (KPS Score) for Pancreatic Cancer Participants | 90.0 score on a scale | Standard Deviation 14.1 |
| Implant 2: Day 30 | Activities of Daily Living (KPS Score) for Pancreatic Cancer Participants | 80.0 score on a scale | — |
Other Pre-specified
Activities of Daily Living (KPS Score) of mCRC Participants
Karnofsky Performance Status (KPS) is a self-rated scale that measures the participant's ability to perform daily functions, ranging from 0 (dead) to 100 (normal, no complaints, no evidence of disease). Karnofsky scores are defined as follows: 100: Normal; no complaints; no evidence of disease 90: Able to carry on normal activity with effort, minor sign or symptoms of disease 80: Normal activity with effort; some sign or symptoms of disease 70: Cares for self; unable to carry on normal activity or do active work 60: Requires occasional assistance, but is able to care for most personal needs 50: Requires considerable assistance and frequent medical care 40: Disabled; requires special care and assistance 30: Severely disabled; hospitalization is indicated, although death is not imminent 20: Very sick; hospitalization/active support treatment is necessary 10: Moribund; fatal processes progressively worsening 0: Dead
Time frame: Baseline; Day 14, 30, 60 Post-Implant 1; Day 14, 30, 60 post-Implant 2
Population: Implant 1 (Days 0-60): Participants with mCRC who had received at least 1 RENCA macrobead implantation and were screened as indicated; Implant 2 (Days 0-60): Participants with mCRC who had received at least 2 RENCA macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Activities of Daily Living (KPS Score) of mCRC Participants | 90.0 score on a scale | Standard Deviation 7.2 |
| Metastatic Colorectal Cancer | Activities of Daily Living (KPS Score) of mCRC Participants | 81.2 score on a scale | Standard Deviation 11.8 |
| Increased | Activities of Daily Living (KPS Score) of mCRC Participants | 80.4 score on a scale | Standard Deviation 11.6 |
| mCRC: Non-responder | Activities of Daily Living (KPS Score) of mCRC Participants | 74.1 score on a scale | Standard Deviation 16.6 |
| Implant 2: Day 0 | Activities of Daily Living (KPS Score) of mCRC Participants | 84.2 score on a scale | Standard Deviation 9.1 |
| Implant 2: Day 14 | Activities of Daily Living (KPS Score) of mCRC Participants | 76.3 score on a scale | Standard Deviation 11.9 |
| Implant 2: Day 30 | Activities of Daily Living (KPS Score) of mCRC Participants | 82.7 score on a scale | Standard Deviation 9.1 |
| Implant 2: Day 60 | Activities of Daily Living (KPS Score) of mCRC Participants | 76.0 score on a scale | Standard Deviation 16.5 |
Other Pre-specified
Cancer Antigen 125 Levels in mCRC Participants
Cancer Antigen 125 (CA 125) is one of three inflammatory markers assessed during this study. CA 125 was used to monitor more localized intra-abdominal/peritoneal inflammatory processes related to the placement of the RENCA macrobeads or, in some cases, the intraperitoneal spread of tumor.
Time frame: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).
Population: Implant 1 (Days 0-60): Participants with mCRC who had received at least 1 RENCA macrobead implantation and were screened as indicated; Implant 2 (Days 0-60): Participants with mCRC who had received at least 2 RENCA macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Cancer Antigen 125 Levels in mCRC Participants | 43.5 U/mL | Standard Deviation 76.65 |
| Metastatic Colorectal Cancer | Cancer Antigen 125 Levels in mCRC Participants | 95.5 U/mL | Standard Deviation 73.5 |
| Increased | Cancer Antigen 125 Levels in mCRC Participants | 83.7 U/mL | Standard Deviation 86.6 |
| mCRC: Non-responder | Cancer Antigen 125 Levels in mCRC Participants | 67.6 U/mL | Standard Deviation 106.1 |
| Implant 2: Day 0 | Cancer Antigen 125 Levels in mCRC Participants | 39.2 U/mL | Standard Deviation 49.1 |
| Implant 2: Day 14 | Cancer Antigen 125 Levels in mCRC Participants | 63.7 U/mL | Standard Deviation 29.1 |
| Implant 2: Day 30 | Cancer Antigen 125 Levels in mCRC Participants | 48.7 U/mL | Standard Deviation 31.4 |
| Implant 2: Day 60 | Cancer Antigen 125 Levels in mCRC Participants | 38.0 U/mL | Standard Deviation 31.9 |
Other Pre-specified
Cancer Antigen 125 Levels in Pancreatic Cancer Participants
Cancer Antigen 125 (CA 125) is one of three inflammatory markers assessed during this study. CA 125 was used to monitor more localized intra-abdominal/peritoneal inflammatory processes related to the placement of the RENCA macrobeads or, in some cases, the intraperitoneal spread of tumor.
Time frame: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).
Population: Implant 1 (Days 0-60): Pancreatic cancer participants who had received at least 1 implant and were screened as indicated; Implant 2 (Days 0-60): Pancreatic cancer participants who had received at least 2 RENCA macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Cancer Antigen 125 Levels in Pancreatic Cancer Participants | 147.9 U/mL | Standard Deviation 278.6 |
| Metastatic Colorectal Cancer | Cancer Antigen 125 Levels in Pancreatic Cancer Participants | 300.7 U/mL | Standard Deviation 410.6 |
| Increased | Cancer Antigen 125 Levels in Pancreatic Cancer Participants | 409.4 U/mL | Standard Deviation 607 |
| mCRC: Non-responder | Cancer Antigen 125 Levels in Pancreatic Cancer Participants | 291.7 U/mL | Standard Deviation 289.2 |
| Implant 2: Day 0 | Cancer Antigen 125 Levels in Pancreatic Cancer Participants | 49.7 U/mL | Standard Deviation 30.1 |
| Implant 2: Day 14 | Cancer Antigen 125 Levels in Pancreatic Cancer Participants | 88.5 U/mL | Standard Deviation 7.8 |
| Implant 2: Day 30 | Cancer Antigen 125 Levels in Pancreatic Cancer Participants | 117.0 U/mL | Standard Deviation 46.7 |
| Implant 2: Day 60 | Cancer Antigen 125 Levels in Pancreatic Cancer Participants | 57.0 U/mL | — |
Other Pre-specified
Cognitive Function of mCRC Participants
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including cognitive function), three symptom scales, a global health status score, and six single items. Cognitive Function is assessed from 2 of the 30 questions (Question 20 and 25), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.
Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2
Population: Implant 1 (Day 0 to Day 60): Participants with mCRC who had received at least 1 RENCA macrobead implantation; Implant 2 (Day 0 to Day 60): Participants with mCRC who had received at least 2 RENCA macrobead implantations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Cognitive Function of mCRC Participants | 86.9 score on a scale | Standard Deviation 18.5 |
| Metastatic Colorectal Cancer | Cognitive Function of mCRC Participants | 84.4 score on a scale | Standard Deviation 19 |
| Increased | Cognitive Function of mCRC Participants | 82.1 score on a scale | Standard Deviation 25.3 |
| mCRC: Non-responder | Cognitive Function of mCRC Participants | 79.5 score on a scale | Standard Deviation 22.7 |
| Implant 2: Day 0 | Cognitive Function of mCRC Participants | 71.7 score on a scale | Standard Deviation 24.9 |
| Implant 2: Day 14 | Cognitive Function of mCRC Participants | 72.2 score on a scale | Standard Deviation 30 |
Other Pre-specified
Cognitive Function of Pancreatic Cancer Participants
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including cognitive function), three symptom scales, a global health status score, and six single items. Cognitive Function is assessed from 2 of the 30 questions (Question 20 and 25), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.
Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2
Population: Implant 1 (Day 0 to Day 60): Pancreatic cancer participants who had received at least 1 macrobead implantation; Implant 2 (Day 0 to Day 60): Pancreatic cancer participants who had received at least 2 macrobead implantations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Cognitive Function of Pancreatic Cancer Participants | 87.5 score on a scale | Standard Deviation 18.6 |
| Metastatic Colorectal Cancer | Cognitive Function of Pancreatic Cancer Participants | 72.2 score on a scale | Standard Deviation 39.2 |
| Increased | Cognitive Function of Pancreatic Cancer Participants | 73.1 score on a scale | Standard Deviation 36.3 |
| mCRC: Non-responder | Cognitive Function of Pancreatic Cancer Participants | 79.5 score on a scale | Standard Deviation 22.7 |
| Implant 2: Day 0 | Cognitive Function of Pancreatic Cancer Participants | 71.7 score on a scale | Standard Deviation 24.9 |
| Implant 2: Day 14 | Cognitive Function of Pancreatic Cancer Participants | 72.2 score on a scale | Standard Deviation 30 |
Other Pre-specified
C-reactive Protein Levels in mCRC Participants
C-reactive protein (CRP) is one of three inflammatory markers assessed during this study. CRP levels were assessed as a marker of systemic inflammatory processes.
Time frame: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).
Population: Implant 1 (Days 0-60): Participants with mCRC who had received at least 1 RENCA macrobead implantation and were screened as indicated; Implant 2 (Days 0-60): Participants with mCRC who had received at least 2 RENCA macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | C-reactive Protein Levels in mCRC Participants | 3.1 mg/dL | Standard Deviation 4.2 |
| Metastatic Colorectal Cancer | C-reactive Protein Levels in mCRC Participants | 19.3 mg/dL | Standard Deviation 8.1 |
| Increased | C-reactive Protein Levels in mCRC Participants | 8.9 mg/dL | Standard Deviation 5.9 |
| mCRC: Non-responder | C-reactive Protein Levels in mCRC Participants | 6.7 mg/dL | Standard Deviation 6.9 |
| Implant 2: Day 0 | C-reactive Protein Levels in mCRC Participants | 10.2 mg/dL | Standard Deviation 23.6 |
| Implant 2: Day 14 | C-reactive Protein Levels in mCRC Participants | 23.5 mg/dL | Standard Deviation 50.8 |
| Implant 2: Day 30 | C-reactive Protein Levels in mCRC Participants | 11.4 mg/dL | Standard Deviation 8.3 |
| Implant 2: Day 60 | C-reactive Protein Levels in mCRC Participants | 5.5 mg/dL | Standard Deviation 4.1 |
Other Pre-specified
C-Reactive Protein Levels in Pancreatic Cancer Participants
C-reactive protein (CRP) is one of three inflammatory markers assessed during this study. CRP levels were assessed as a marker of systemic inflammatory processes.
Time frame: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).
Population: Implant 1 (Days 0-60): Pancreatic cancer participants who had received at least 1 implant and were screened as indicated; Implant 2 (Days 0-60): Pancreatic cancer participants who had received at least 2 RENCA macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | C-Reactive Protein Levels in Pancreatic Cancer Participants | 1.7 mg/dL | Standard Deviation 2 |
| Metastatic Colorectal Cancer | C-Reactive Protein Levels in Pancreatic Cancer Participants | 30.7 mg/dL | Standard Deviation 46.7 |
| Increased | C-Reactive Protein Levels in Pancreatic Cancer Participants | 13.8 mg/dL | Standard Deviation 22.9 |
| mCRC: Non-responder | C-Reactive Protein Levels in Pancreatic Cancer Participants | 6.7 mg/dL | Standard Deviation 11.6 |
| Implant 2: Day 0 | C-Reactive Protein Levels in Pancreatic Cancer Participants | 1.4 mg/dL | Standard Deviation 1.3 |
| Implant 2: Day 14 | C-Reactive Protein Levels in Pancreatic Cancer Participants | 3.1 mg/dL | Standard Deviation 1.7 |
| Implant 2: Day 30 | C-Reactive Protein Levels in Pancreatic Cancer Participants | 89.8 mg/dL | Standard Deviation 148.4 |
| Implant 2: Day 60 | C-Reactive Protein Levels in Pancreatic Cancer Participants | 7.52 mg/dL | — |
Other Pre-specified
Emotional Function of mCRC Participants
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including emotional function), three symptom scales, a global health status score, and six single items. Emotional Function is assessed from 4 of the 30 questions (Questions 21-24), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 4 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.
Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2
Population: Implant 1 (Day 0 to Day 60): Participants with mCRC who had received at least 1 RENCA macrobead implantation; Implant 2 (Day 0 to Day 60): Participants with mCRC who had received at least 2 RENCA macrobead implantations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Emotional Function of mCRC Participants | 83.3 score on a scale | Standard Deviation 18.5 |
| Metastatic Colorectal Cancer | Emotional Function of mCRC Participants | 78.1 score on a scale | Standard Deviation 18.4 |
| Increased | Emotional Function of mCRC Participants | 74.3 score on a scale | Standard Deviation 22.2 |
| mCRC: Non-responder | Emotional Function of mCRC Participants | 84.0 score on a scale | Standard Deviation 16.8 |
| Implant 2: Day 0 | Emotional Function of mCRC Participants | 75.8 score on a scale | Standard Deviation 21.3 |
| Implant 2: Day 14 | Emotional Function of mCRC Participants | 75.9 score on a scale | Standard Deviation 17.4 |
Other Pre-specified
Emotional Function of Pancreatic Cancer Participants
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including emotional function), three symptom scales, a global health status score, and six single items. Emotional Function is assessed from 4 of the 30 questions (Questions 21-24), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 4 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.
Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2
Population: Implant 1 (Day 0 to Day 60): Pancreatic cancer participants who had received at least 1 macrobead implantation; Implant 2 (Day 0 to Day 60): Pancreatic cancer participants who had received at least 2 macrobead implantations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Emotional Function of Pancreatic Cancer Participants | 82.3 score on a scale | Standard Deviation 20.3 |
| Metastatic Colorectal Cancer | Emotional Function of Pancreatic Cancer Participants | 70.4 score on a scale | Standard Deviation 30.9 |
| Increased | Emotional Function of Pancreatic Cancer Participants | 69.2 score on a scale | Standard Deviation 32.9 |
| mCRC: Non-responder | Emotional Function of Pancreatic Cancer Participants | 91.7 score on a scale | Standard Deviation 14.4 |
| Implant 2: Day 0 | Emotional Function of Pancreatic Cancer Participants | 83.3 score on a scale | Standard Deviation 11.8 |
Other Pre-specified
Erythrocyte Sedimentation Rate in mCRC Participants
Erythrocyte sedimentation rate (ESR) is one of three inflammatory markers assessed during this study. ESR was assessed as a marker of systemic inflammatory processes.
Time frame: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).
Population: Implant 1 (Days 0-60): Participants with mCRC who had received at least 1 RENCA macrobead implantation and were screened as indicated; Implant 2 (Days 0-60): Participants with mCRC who had received at least 2 RENCA macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Erythrocyte Sedimentation Rate in mCRC Participants | 44.9 mm/hr | Standard Deviation 30.9 |
| Metastatic Colorectal Cancer | Erythrocyte Sedimentation Rate in mCRC Participants | 92.7 mm/hr | Standard Deviation 31.4 |
| Increased | Erythrocyte Sedimentation Rate in mCRC Participants | 85.8 mm/hr | Standard Deviation 37.3 |
| mCRC: Non-responder | Erythrocyte Sedimentation Rate in mCRC Participants | 68.1 mm/hr | Standard Deviation 39.6 |
| Implant 2: Day 0 | Erythrocyte Sedimentation Rate in mCRC Participants | 53.5 mm/hr | Standard Deviation 16.1 |
| Implant 2: Day 14 | Erythrocyte Sedimentation Rate in mCRC Participants | 93.3 mm/hr | Standard Deviation 27.7 |
| Implant 2: Day 30 | Erythrocyte Sedimentation Rate in mCRC Participants | 92.7 mm/hr | Standard Deviation 23.1 |
| Implant 2: Day 60 | Erythrocyte Sedimentation Rate in mCRC Participants | 74.9 mm/hr | Standard Deviation 28.8 |
Other Pre-specified
Erythrocyte Sedimentation Rate in Pancreatic Cancer Participants
Erythrocyte sedimentation rate (ESR) is one of three inflammatory markers assessed during this study. ESR was assessed as a marker of systemic inflammatory processes.
Time frame: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).
Population: Implant 1 (Days 0-60): Pancreatic cancer participants who had received at least 1 implant and were screened as indicated; Implant 2 (Days 0-60): Pancreatic cancer participants who had received at least 2 RENCA macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Erythrocyte Sedimentation Rate in Pancreatic Cancer Participants | 33 mm/hr | Standard Deviation 24.6 |
| Metastatic Colorectal Cancer | Erythrocyte Sedimentation Rate in Pancreatic Cancer Participants | 51.9 mm/hr | Standard Deviation 31.3 |
| Increased | Erythrocyte Sedimentation Rate in Pancreatic Cancer Participants | 49.2 mm/hr | Standard Deviation 12.9 |
| mCRC: Non-responder | Erythrocyte Sedimentation Rate in Pancreatic Cancer Participants | 78.6 mm/hr | Standard Deviation 13.8 |
| Implant 2: Day 0 | Erythrocyte Sedimentation Rate in Pancreatic Cancer Participants | 83.3 mm/hr | Standard Deviation 5.8 |
| Implant 2: Day 14 | Erythrocyte Sedimentation Rate in Pancreatic Cancer Participants | 90.0 mm/hr | Standard Deviation 14.1 |
| Implant 2: Day 30 | Erythrocyte Sedimentation Rate in Pancreatic Cancer Participants | 80.0 mm/hr | — |
Other Pre-specified
Global Health Status of mCRC Participants
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales, three symptom scales, a global health status score, and six single items. The Global Health Status is assessed from 2 of the 30 questions (Question 29 and 30), whose response score ranges on a 7 point scale. The score for physical function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor) and the maximum value is 100 (best outcome, excellent). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.
Time frame: Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2
Population: Implant 1 (Days 0-60): Participants with mCRC who had received at least 1 RENCA macrobead implantation and were screened as indicated; Implant 2 (Days 0-60): Participants with mCRC who had received at least 2 RENCA macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Global Health Status of mCRC Participants | 94.0 score on a scale | Standard Deviation 8.4 |
| Metastatic Colorectal Cancer | Global Health Status of mCRC Participants | 78.8 score on a scale | Standard Deviation 15.9 |
| Increased | Global Health Status of mCRC Participants | 80.6 score on a scale | Standard Deviation 17.3 |
| mCRC: Non-responder | Global Health Status of mCRC Participants | 75.1 score on a scale | Standard Deviation 25.9 |
| Implant 2: Day 0 | Global Health Status of mCRC Participants | 86.0 score on a scale | Standard Deviation 11.4 |
| Implant 2: Day 14 | Global Health Status of mCRC Participants | 78.6 score on a scale | Standard Deviation 9.6 |
| Implant 2: Day 30 | Global Health Status of mCRC Participants | 86.7 score on a scale | Standard Deviation 9.5 |
| Implant 2: Day 60 | Global Health Status of mCRC Participants | 83.3 score on a scale | Standard Deviation 16.7 |
Other Pre-specified
Global Health Status of Pancreatic Cancer Participants
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales, three symptom scales, a global health status score, and six single items. The Global Health Status is assessed from 2 of the 30 questions (Question 29 and 30), whose response score ranges on a 7 point scale. The score for physical function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor) and the maximum value is 100 (best outcome, excellent). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.
Time frame: Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2
Population: Implant 1 (Days 0-60): Pancreatic cancer participants who had received at least 1 macrobead implantation and were screened as indicated; Implant 2 (Days 0-60): Pancreatic cancer participants who had received at least 2 macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Global Health Status of Pancreatic Cancer Participants | 90.1 score on a scale | Standard Deviation 10.8 |
| Metastatic Colorectal Cancer | Global Health Status of Pancreatic Cancer Participants | 75.2 score on a scale | Standard Deviation 18.8 |
| Increased | Global Health Status of Pancreatic Cancer Participants | 77.8 score on a scale | Standard Deviation 15.9 |
| mCRC: Non-responder | Global Health Status of Pancreatic Cancer Participants | 72.3 score on a scale | Standard Deviation 24.3 |
| Implant 2: Day 0 | Global Health Status of Pancreatic Cancer Participants | 84.2 score on a scale | Standard Deviation 4.6 |
| Implant 2: Day 14 | Global Health Status of Pancreatic Cancer Participants | 26.5 score on a scale | — |
| Implant 2: Day 30 | Global Health Status of Pancreatic Cancer Participants | 25.6 score on a scale | — |
Other Pre-specified
Necrosis Comparison of Tumors Using PET-CT Scan
Tumors were assessed by positron emission tomography (PET)-CT scan at baseline and day 90 following the first RENCA macrobead implantation. The use of \[13\]F-fluorodeoxyglucose (FDG) uptake for the detection of lesions \>1 cm in diameter allowed evaluation of metabolic activity. Decreases in FDG uptake were indicative of metabolic suppression of the tumor. The use of PET-CT scanning indicated anatomical localization, approximate size/volume of primary tumor and metastatic lesion(s), and assessment of metabolic activity of the tumor (as an indicator of metabolic health and necrosis). Disease state is reported as a function of Tumor measurement divided by SUVmax. Changes were assessed between day 90 post RENCA macrobead implant and baseline values. Patients with no change = stable; patients with decreased values = decreased/necrosis, and patients with increased values = increased.
Time frame: Baseline vs. Day 90 post-Implant 1
Population: mCRC participants who had received at least one macrobead implant and for whom baseline PET-CT scan and day 90 post-Implant 1 PET-CT scan data were available. n=26 subjects; 77 lesions evaluated. No formal analysis was performed on the pancreatic cancer cohort as a meaningful analysis was limited based on the small group size with baseline and day 90 scans.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Pancreatic Cancer | Necrosis Comparison of Tumors Using PET-CT Scan | 15 lesions |
| Metastatic Colorectal Cancer | Necrosis Comparison of Tumors Using PET-CT Scan | 42 lesions |
| Increased | Necrosis Comparison of Tumors Using PET-CT Scan | 30 lesions |
Other Pre-specified
Pain Assessment of mCRC Participants
Participants were asked to rate their pain on a discrete scale (from 0 = no pain to 10 worst pain imaginable, unbearable). The worst pain at each time point was used in the analysis.
Time frame: Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2
Population: Implant 1 (Day 0 to Day 60): Participants with mCRC who had received at least 1 RENCA macrobead implantation; Implant 2 (Day 0 to Day 60): Participants with mCRC who had received at least 2 RENCA macrobead implantations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Pain Assessment of mCRC Participants | 1.7 score on a scale | Standard Deviation 2.7 |
| Metastatic Colorectal Cancer | Pain Assessment of mCRC Participants | 3.3 score on a scale | Standard Deviation 3 |
| Increased | Pain Assessment of mCRC Participants | 2.5 score on a scale | Standard Deviation 2.4 |
| mCRC: Non-responder | Pain Assessment of mCRC Participants | 3.8 score on a scale | Standard Deviation 2.7 |
| Implant 2: Day 0 | Pain Assessment of mCRC Participants | 2.2 score on a scale | Standard Deviation 2.8 |
| Implant 2: Day 14 | Pain Assessment of mCRC Participants | 5.4 score on a scale | Standard Deviation 2.2 |
| Implant 2: Day 30 | Pain Assessment of mCRC Participants | 4.2 score on a scale | Standard Deviation 3 |
| Implant 2: Day 60 | Pain Assessment of mCRC Participants | 4.2 score on a scale | Standard Deviation 3.6 |
Other Pre-specified
Pain Assessment of Pancreatic Cancer Participants
Participants were asked to rate their pain on a discrete scale (from 0 = no pain to 10 worst pain imaginable, unbearable). The worst pain at each time point was used in the analysis.
Time frame: Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2
Population: Implant 1 (Day 0 to Day 60): Pancreatic cancer participants who had received at least 1 macrobead implantation; Implant 2 (Day 0 to Day 60): Pancreatic cancer participants who had received at least 2 macrobead implantations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Pain Assessment of Pancreatic Cancer Participants | 1.5 score on a scale | Standard Deviation 2.1 |
| Metastatic Colorectal Cancer | Pain Assessment of Pancreatic Cancer Participants | 2.3 score on a scale | Standard Deviation 3.2 |
| Increased | Pain Assessment of Pancreatic Cancer Participants | 2.9 score on a scale | Standard Deviation 2.5 |
| mCRC: Non-responder | Pain Assessment of Pancreatic Cancer Participants | 3.9 score on a scale | Standard Deviation 2.4 |
| Implant 2: Day 0 | Pain Assessment of Pancreatic Cancer Participants | 5.5 score on a scale | Standard Deviation 3 |
| Implant 2: Day 14 | Pain Assessment of Pancreatic Cancer Participants | 4.0 score on a scale | — |
| Implant 2: Day 30 | Pain Assessment of Pancreatic Cancer Participants | 3.7 score on a scale | Standard Deviation 1.8 |
Other Pre-specified
Performance Status (ECOG Score) of mCRC Participants
The Eastern Cooperative Oncology Group (ECOG) performance scale is a 5-point scale, where 0 denotes perfect health and 5 is death. It is used by clinicians to assess disease progression and how the disease is affecting the daily living abilities of the patient. The ECOG Performance Status scores are defined as follows: 0: Fully active, able to carry on all pre-disease activities without restriction. 1. Restricted in physical strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g. light house work, office work). 2. Ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair 50% or more of waking hours. 4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair. 5. Death
Time frame: Baseline; Day 14, 30, 60 post-Implant; Day 14, 30, 60 post-Implant 2
Population: Implant (day 0 to day 60): Participants with mCRC who received at least one RENCA macrobead implantation; Implant 2 (day 0 to day 60): Participants who received at least two RENCA macrobead implantations.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pancreatic Cancer | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 5 | 0 Participants |
| Pancreatic Cancer | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 0 | 13 Participants |
| Pancreatic Cancer | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 1 | 15 Participants |
| Pancreatic Cancer | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 2 | 0 Participants |
| Pancreatic Cancer | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 4 | 0 Participants |
| Pancreatic Cancer | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 3 | 0 Participants |
| Metastatic Colorectal Cancer | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 2 | 5 Participants |
| Metastatic Colorectal Cancer | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 0 | 4 Participants |
| Metastatic Colorectal Cancer | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 3 | 1 Participants |
| Metastatic Colorectal Cancer | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 5 | 0 Participants |
| Metastatic Colorectal Cancer | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 1 | 15 Participants |
| Metastatic Colorectal Cancer | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 4 | 0 Participants |
| Increased | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 4 | 0 Participants |
| Increased | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 2 | 3 Participants |
| Increased | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 1 | 16 Participants |
| Increased | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 3 | 2 Participants |
| Increased | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 5 | 0 Participants |
| Increased | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 0 | 3 Participants |
| mCRC: Non-responder | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 4 | 0 Participants |
| mCRC: Non-responder | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 0 | 4 Participants |
| mCRC: Non-responder | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 1 | 10 Participants |
| mCRC: Non-responder | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 2 | 6 Participants |
| mCRC: Non-responder | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 3 | 4 Participants |
| mCRC: Non-responder | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 5 | 0 Participants |
| Implant 2: Day 0 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 4 | 0 Participants |
| Implant 2: Day 0 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 1 | 5 Participants |
| Implant 2: Day 0 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 5 | 0 Participants |
| Implant 2: Day 0 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 0 | 5 Participants |
| Implant 2: Day 0 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 3 | 0 Participants |
| Implant 2: Day 0 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 2 | 2 Participants |
| Implant 2: Day 14 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 2 | 3 Participants |
| Implant 2: Day 14 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 3 | 0 Participants |
| Implant 2: Day 14 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 1 | 3 Participants |
| Implant 2: Day 14 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 4 | 0 Participants |
| Implant 2: Day 14 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 0 | 0 Participants |
| Implant 2: Day 14 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 5 | 0 Participants |
| Implant 2: Day 30 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 3 | 0 Participants |
| Implant 2: Day 30 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 4 | 0 Participants |
| Implant 2: Day 30 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 0 | 2 Participants |
| Implant 2: Day 30 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 2 | 3 Participants |
| Implant 2: Day 30 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 5 | 0 Participants |
| Implant 2: Day 30 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 1 | 4 Participants |
| Implant 2: Day 60 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 3 | 1 Participants |
| Implant 2: Day 60 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 2 | 2 Participants |
| Implant 2: Day 60 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 5 | 0 Participants |
| Implant 2: Day 60 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 4 | 0 Participants |
| Implant 2: Day 60 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 0 | 1 Participants |
| Implant 2: Day 60 | Performance Status (ECOG Score) of mCRC Participants | ECOG Score 1 | 5 Participants |
Other Pre-specified
Performance Status (ECOG Score) of Pancreatic Cancer Participants
The Eastern Cooperative Oncology Group (ECOG) performance scale is a 5-point scale, where 0 denotes perfect health and 5 is death. It is used by clinicians to assess disease progression and how the disease is affecting the daily living abilities of the patient. The ECOG Performance Status scores are defined as follows: 0: Fully active, able to carry on all pre-disease activities without restriction. 1. Restricted in physical strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g. light house work, office work). 2. Ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair 50% or more of waking hours. 4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair. 5. Death
Time frame: Baseline; Day 14, 30, 60 post-Implant; Day 14, 30, 60 post-Implant 2
Population: Implant 1 (Days 0-60): Pancreatic cancer participants who had received at least 1 macrobead implantation and were screened as indicated; Implant 2 (Days 0-60): Pancreatic cancer participants who had received at least 2 macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pancreatic Cancer | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 5 | 0 Participants |
| Pancreatic Cancer | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 1 | 7 Participants |
| Pancreatic Cancer | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 3 | 0 Participants |
| Pancreatic Cancer | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 0 | 11 Participants |
| Pancreatic Cancer | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 2 | 5 Participants |
| Pancreatic Cancer | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 4 | 0 Participants |
| Metastatic Colorectal Cancer | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 0 | 1 Participants |
| Metastatic Colorectal Cancer | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 3 | 1 Participants |
| Metastatic Colorectal Cancer | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 5 | 0 Participants |
| Metastatic Colorectal Cancer | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 1 | 11 Participants |
| Metastatic Colorectal Cancer | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 4 | 0 Participants |
| Metastatic Colorectal Cancer | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 2 | 7 Participants |
| Increased | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 4 | 0 Participants |
| Increased | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 2 | 5 Participants |
| Increased | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 5 | 0 Participants |
| Increased | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 3 | 0 Participants |
| Increased | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 0 | 3 Participants |
| Increased | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 1 | 8 Participants |
| mCRC: Non-responder | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 4 | 0 Participants |
| mCRC: Non-responder | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 0 | 4 Participants |
| mCRC: Non-responder | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 1 | 4 Participants |
| mCRC: Non-responder | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 2 | 2 Participants |
| mCRC: Non-responder | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 3 | 2 Participants |
| mCRC: Non-responder | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 5 | 0 Participants |
| Implant 2: Day 0 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 3 | 0 Participants |
| Implant 2: Day 0 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 1 | 1 Participants |
| Implant 2: Day 0 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 4 | 0 Participants |
| Implant 2: Day 0 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 5 | 0 Participants |
| Implant 2: Day 0 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 2 | 1 Participants |
| Implant 2: Day 0 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 0 | 1 Participants |
| Implant 2: Day 14 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 2 | 0 Participants |
| Implant 2: Day 14 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 3 | 0 Participants |
| Implant 2: Day 14 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 1 | 1 Participants |
| Implant 2: Day 14 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 4 | 0 Participants |
| Implant 2: Day 14 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 0 | 1 Participants |
| Implant 2: Day 14 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 5 | 0 Participants |
| Implant 2: Day 30 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 2 | 0 Participants |
| Implant 2: Day 30 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 1 | 2 Participants |
| Implant 2: Day 30 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 5 | 0 Participants |
| Implant 2: Day 30 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 3 | 0 Participants |
| Implant 2: Day 30 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 4 | 0 Participants |
| Implant 2: Day 30 | Performance Status (ECOG Score) of Pancreatic Cancer Participants | ECOG Score 0 | 0 Participants |
Other Pre-specified
Physical Function of mCRC Participants
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including physical function), three symptom scales, a global health status score, and six single items. Physical Function is assessed from 5 of the 30 questions (Questions 1-5), whose response score ranges on a 4 point scale. The score for physical function is calculated based on the average score from these 5 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.
Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2
Population: Implant 1 (Day 0 to Day 60): Participants with mCRC who had received at least 1 RENCA macrobead implantation; Implant 2 (Day 0 to Day 60): Participants with mCRC who had received at least 2 RENCA macrobead implantations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Physical Function of mCRC Participants | 86.9 score on a scale | Standard Deviation 16.2 |
| Metastatic Colorectal Cancer | Physical Function of mCRC Participants | 69.8 score on a scale | Standard Deviation 26.9 |
| Increased | Physical Function of mCRC Participants | 66.9 score on a scale | Standard Deviation 28.4 |
| mCRC: Non-responder | Physical Function of mCRC Participants | 78.5 score on a scale | Standard Deviation 16.8 |
| Implant 2: Day 0 | Physical Function of mCRC Participants | 66.7 score on a scale | Standard Deviation 25.5 |
| Implant 2: Day 14 | Physical Function of mCRC Participants | 63.7 score on a scale | Standard Deviation 35 |
Other Pre-specified
Physical Function of Pancreatic Cancer Participants
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including physical function), three symptom scales, a global health status score, and six single items. Physical Function is assessed from 5 of the 30 questions (Questions 1-5), whose response score ranges on a 4 point scale. The score for physical function is calculated based on the average score from these 5 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.
Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2
Population: Implant 1 (Day 0 to Day 60): Pancreatic cancer participants who had received at least 1 macrobead implantation; Implant 2 (Day 0 to Day 60): Pancreatic cancer participants who had received at least 2 macrobead implantations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Physical Function of Pancreatic Cancer Participants | 81.1 score on a scale | Standard Deviation 20.6 |
| Metastatic Colorectal Cancer | Physical Function of Pancreatic Cancer Participants | 62.5 score on a scale | Standard Deviation 28.5 |
| Increased | Physical Function of Pancreatic Cancer Participants | 64.1 score on a scale | Standard Deviation 33.7 |
| mCRC: Non-responder | Physical Function of Pancreatic Cancer Participants | 91.1 score on a scale | Standard Deviation 10.2 |
| Implant 2: Day 0 | Physical Function of Pancreatic Cancer Participants | 76.7 score on a scale | Standard Deviation 23.6 |
Other Pre-specified
Role Function of mCRC Participants
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including role function), three symptom scales, a global health status score, and six single items. Role Function is assessed from 2 of the 30 questions (Questions 6 and 7), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.
Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2
Population: Implant 1 (Day 0 to Day 60): Participants with mCRC who had received at least 1 RENCA macrobead implantation; Implant 2 (Day 0 to Day 60): Participants with mCRC who had received at least 2 RENCA macrobead implantations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Role Function of mCRC Participants | 85.9 score on a scale | Standard Deviation 17.5 |
| Metastatic Colorectal Cancer | Role Function of mCRC Participants | 58.3 score on a scale | Standard Deviation 29.3 |
| Increased | Role Function of mCRC Participants | 56.0 score on a scale | Standard Deviation 36.9 |
| mCRC: Non-responder | Role Function of mCRC Participants | 75.6 score on a scale | Standard Deviation 32.4 |
| Implant 2: Day 0 | Role Function of mCRC Participants | 55.0 score on a scale | Standard Deviation 36.9 |
| Implant 2: Day 14 | Role Function of mCRC Participants | 51.9 score on a scale | Standard Deviation 32.8 |
Other Pre-specified
Role Function of Pancreatic Cancer Participants
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including role function), three symptom scales, a global health status score, and six single items. Role Function is assessed from 2 of the 30 questions (Questions 6 and 7), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.
Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2
Population: Implant 1 (Day 0 to Day 60): Participants with pancreatic cancer who had received at least 1 RENCA macrobead implantation; Implant 2 (Day 0 to Day 60): Participants with pancreatic cancer who had received at least 2 RENCA macrobead implantations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Role Function of Pancreatic Cancer Participants | 80.6 score on a scale | Standard Deviation 27.2 |
| Metastatic Colorectal Cancer | Role Function of Pancreatic Cancer Participants | 58.5 score on a scale | Standard Deviation 32.3 |
| Increased | Role Function of Pancreatic Cancer Participants | 52.6 score on a scale | Standard Deviation 36.5 |
| mCRC: Non-responder | Role Function of Pancreatic Cancer Participants | 83.3 score on a scale | Standard Deviation 16.7 |
| Implant 2: Day 0 | Role Function of Pancreatic Cancer Participants | 50.0 score on a scale | Standard Deviation 23.6 |
Other Pre-specified
Social Function of mCRC Participants
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including social function), three symptom scales, a global health status score, and six single items. Social Function is assessed from 2 of the 30 questions (Question 26 and 27), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.
Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2
Population: Implant 1 (Day 0 to Day 60): Participants with mCRC who had received at least 1 RENCA macrobead implantation; Implant 2 (Day 0 to Day 60): Participants with mCRC who had received at least 2 RENCA macrobead implantations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Social Function of mCRC Participants | 82.8 score on a scale | Standard Deviation 21.8 |
| Metastatic Colorectal Cancer | Social Function of mCRC Participants | 67.2 score on a scale | Standard Deviation 30.5 |
| Increased | Social Function of mCRC Participants | 59.9 score on a scale | Standard Deviation 36.5 |
| mCRC: Non-responder | Social Function of mCRC Participants | 70.5 score on a scale | Standard Deviation 27.3 |
| Implant 2: Day 0 | Social Function of mCRC Participants | 60.0 score on a scale | Standard Deviation 27.4 |
| Implant 2: Day 14 | Social Function of mCRC Participants | 53.7 score on a scale | Standard Deviation 35.1 |
Other Pre-specified
Social Function of Pancreatic Cancer Participants
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including social function), three symptom scales, a global health status score, and six single items. Social Function is assessed from 2 of the 30 questions (Question 26 and 27), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.
Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2
Population: Implant 1 (Day 0 to Day 60): Pancreatic cancer participants who had received at least 1 macrobead implantation; Implant 2 (Day 0 to Day 60): Pancreatic cancer participants who had received at least 2 macrobead implantations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pancreatic Cancer | Social Function of Pancreatic Cancer Participants | 76.4 score on a scale | Standard Deviation 31.1 |
| Metastatic Colorectal Cancer | Social Function of Pancreatic Cancer Participants | 58.8 score on a scale | Standard Deviation 30.1 |
| Increased | Social Function of Pancreatic Cancer Participants | 61.5 score on a scale | Standard Deviation 33.6 |
| mCRC: Non-responder | Social Function of Pancreatic Cancer Participants | 77.8 score on a scale | Standard Deviation 19.2 |
| Implant 2: Day 0 | Social Function of Pancreatic Cancer Participants | 50.0 score on a scale | Standard Deviation 0 |
Other Pre-specified
Tumor Marker Response of mCRC Participants
Tumor markers included serum carcinoembryonic antigen (CEA) and cancer antigen 19-9 (CA 19-9), and were assessed on all participants with mCRC at baseline and at subsequent evaluation points to further assess tumor response to RENCA macrobead implantation. A tumor marker response was defined as a greater than or equal to 20% decrease in one or both of CEA or CA 19-9.
Time frame: Change from baseline up to and including day 30 post-Implant 1
Population: Participants with mCRC receiving at least one RENCA macrobead implantation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pancreatic Cancer | Tumor Marker Response of mCRC Participants | 7 Participants |
| Metastatic Colorectal Cancer | Tumor Marker Response of mCRC Participants | 3 Participants |
| Increased | Tumor Marker Response of mCRC Participants | 15 Participants |
| mCRC: Non-responder | Tumor Marker Response of mCRC Participants | 9 Participants |
Other Pre-specified
Tumor Marker Response of Pancreatic Cancer Participants
Tumor markers included serum carcinoembryonic antigen (CEA) and cancer antigen 19-9 (CA 19-9), and were assessed on all participants with pancreatic cancer at baseline and at subsequent evaluation points to further assess tumor response to RENCA macrobead implantation. A tumor marker response was defined as a greater than or equal to 20% decrease in one or both of CEA or CA 19-9.
Time frame: Change from baseline up to and including day 30 post-Implant 1.
Population: Participants with pancreatic cancer receiving at least one RENCA macrobead implantation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pancreatic Cancer | Tumor Marker Response of Pancreatic Cancer Participants | 3 Participants |
| Metastatic Colorectal Cancer | Tumor Marker Response of Pancreatic Cancer Participants | 1 Participants |
| Increased | Tumor Marker Response of Pancreatic Cancer Participants | 6 Participants |
| mCRC: Non-responder | Tumor Marker Response of Pancreatic Cancer Participants | 14 Participants |