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| Name | Class |
|---|---|
| Vital Systems Inc. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macrobead Implantation | Experimental | patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at an amount of 8 RENCA macrobeads per kilogram of body weight |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RENCA macrobeads | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of the most recent scan (disease progression) prior to the first macrobead implantation; assessed up to 32 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of the first RENCA macrobead implant; assessed up to 32 months. |
| Overall Survival - Based on Stage IV Disease Diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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:
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:
Adequate hepatic function, defined as follows:
Adequate renal function, defined as serum creatinine ≤ 2.0 mg/dL.
Adequate coagulation function, defined as follows:
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:
Inadequate hepatic function, defined as follows:
Inadequate renal function, defined as serum creatinine > 2.0 mg/dL.
Inadequate coagulation function, defined as follows:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Fahey, III., MD | Weill Cornell Medical Center / New York-Presbyterian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical Center / The Rogosin Institute | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21266363 | Background | Smith BH, Gazda LS, Conn BL, Jain K, Asina S, Levine DM, Parker TS, Laramore MA, Martis PC, Vinerean HV, David EM, Qiu S, Cordon-Cardo C, Hall RD, Gordon BR, Diehl CH, Stenzel KH, Rubin AL. Three-dimensional culture of mouse renal carcinoma cells in agarose macrobeads selects for a subpopulation of cells with cancer stem cell or cancer progenitor properties. Cancer Res. 2011 Feb 1;71(3):716-24. doi: 10.1158/0008-5472.CAN-10-2254. Epub 2011 Jan 24. | |
| 21266362 |
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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 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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Metastatic Colorectal Cancer |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 12, 2014 | Dec 29, 2020 |
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The secondary efficacy objective was to evaluate overall survival calculated using the time from Stage IV disease diagnosis to death from any cause. |
| From date of Stage IV disease diagnosis up to 126 months; up to 32 months from first RENCA macrobead implant. |
| Baseline vs. Day 90 post-Implant 1 |
| 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. | Change from baseline up to and including day 30 post-Implant 1 |
| 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. | Change from baseline up to and including day 30 post-Implant 1. |
| 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. | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). |
| 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. | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). |
| 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. | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). |
| 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. | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). |
| 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. | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). |
| 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. | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). |
| 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.
| Baseline; Day 14, 30, 60 post-Implant; Day 14, 30, 60 post-Implant 2 |
| 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.
| Baseline; Day 14, 30, 60 post-Implant; Day 14, 30, 60 post-Implant 2 |
| 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 | Baseline; Day 14, 30, 60 Post-Implant 1; Day 14, 30, 60 post-Implant 2 |
| 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 | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 |
| 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. | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 |
| 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. | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 |
| 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. | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
| 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. | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
| 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. | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
| 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. | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
| 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. | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
| 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. | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
| 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. | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
| 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. | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
| 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. | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
| 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. | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
| 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. | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 |
| 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. | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 |
| Background |
| Smith BH, Gazda LS, Conn BL, Jain K, Asina S, Levine DM, Parker TS, Laramore MA, Martis PC, Vinerean HV, David EM, Qiu S, North AJ, Couto CG, Post GS, Waters DJ, Cordon-Cardo C, Hall RD, Gordon BR, Diehl CH, Stenzel KH, Rubin AL. Hydrophilic agarose macrobead cultures select for outgrowth of carcinoma cell populations that can restrict tumor growth. Cancer Res. 2011 Feb 1;71(3):725-35. doi: 10.1158/0008-5472.CAN-10-2258. Epub 2011 Jan 24. |
| 29545721 | Background | Smith BH, Gazda LS, Fahey TJ, Nazarian A, Laramore MA, Martis P, Andrada ZP, Thomas J, Parikh T, Sureshbabu S, Berman N, Ocean AJ, Hall RD, Wolf DJ. Clinical laboratory and imaging evidence for effectiveness of agarose-agarose macrobeads containing stem-like cells derived from a mouse renal adenocarcinoma cell population (RMBs) in treatment-resistant, advanced metastatic colorectal cancer: Evaluation of a biological-systems approach to cancer therapy (U.S. FDA IND-BB 10091; NCT 02046174, NCT 01053013). Chin J Cancer Res. 2018 Feb;30(1):72-83. doi: 10.21147/j.issn.1000-9604.2018.01.08. |
| 24025409 | Background | Gazda LS, Martis PC, Laramore MA, Bautista MA, Dudley A, Vinerean HV, Smith BH. Treatment of agarose-agarose RENCA macrobeads with docetaxel selects for OCT4(+) cells with tumor-initiating capability. Cancer Biol Ther. 2013 Dec;14(12):1147-57. doi: 10.4161/cbt.26455. Epub 2013 Sep 12. |
| 30514247 | Background | Martis PC, Dudley AT, Bemrose MA, Gazda HL, Smith BH, Gazda LS. MEF2 plays a significant role in the tumor inhibitory mechanism of encapsulated RENCA cells via EGF receptor signaling in target tumor cells. BMC Cancer. 2018 Dec 4;18(1):1217. doi: 10.1186/s12885-018-5128-5. |
| 27499645 | Background | Smith BH, Parikh T, Andrada ZP, Fahey TJ, Berman N, Wiles M, Nazarian A, Thomas J, Arreglado A, Akahoho E, Wolf DJ, Levine DM, Parker TS, Gazda LS, Ocean AJ. First-in-Human Phase 1 Trial of Agarose Beads Containing Murine RENCA Cells in Advanced Solid Tumors. Cancer Growth Metastasis. 2016 Aug 2;9:9-20. doi: 10.4137/CGM.S39442. eCollection 2016. |
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 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| 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. | Participants who received at least one RENCA macrobead implant. | Posted | Median | 95% Confidence Interval | months | From date of the most recent scan (disease progression) prior to the first macrobead implantation; assessed up to 32 months. |
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| 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. | Participants who received at least one RENCA macrobead implant. | Posted | Median | 95% Confidence Interval | months | From date of the first RENCA macrobead implant; assessed up to 32 months. |
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| 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. | 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. | Posted | Count of Units | lesions | Baseline vs. Day 90 post-Implant 1 | lesions | lesions |
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| 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. | Participants with mCRC receiving at least one RENCA macrobead implantation. | Posted | Count of Participants | Participants | Change from baseline up to and including day 30 post-Implant 1 |
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| 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. | Participants with pancreatic cancer receiving at least one RENCA macrobead implantation. | Posted | Count of Participants | Participants | Change from baseline up to and including day 30 post-Implant 1. |
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| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). |
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| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). |
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| 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. | 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. | Posted | Mean | Standard Deviation | mm/hr | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). |
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| 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. | 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. | Posted | Mean | Standard Deviation | mm/hr | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). |
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| 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. | 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. | Posted | Mean | Standard Deviation | U/mL | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). |
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| 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. | 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. | Posted | Mean | Standard Deviation | U/mL | Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable). |
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| 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.
| 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. | Posted | Count of Participants | Participants | Baseline; Day 14, 30, 60 post-Implant; Day 14, 30, 60 post-Implant 2 |
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| 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.
| 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. | Posted | Count of Participants | Participants | Baseline; Day 14, 30, 60 post-Implant; Day 14, 30, 60 post-Implant 2 |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 14, 30, 60 Post-Implant 1; Day 14, 30, 60 post-Implant 2 |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2 |
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| 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. | Participants who received at least one RENCA macrobead implant. | Posted | Median | 95% Confidence Interval | months | From date of Stage IV disease diagnosis up to 126 months; up to 32 months from first RENCA macrobead implant. |
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From date of first macrobead implantation; assessed up to 32 months.
The NCI CTCAE was used to standardize the terminology and grade the severity of reported adverse events. The Principal and Sub-Investigators, and Attending Physicians, were responsible for monitoring adverse events and the safety of all participants. The Data Safety Monitoring Board, independently and in collaboration with the PIs, monitored and reviewed all safety findings, including study status, serious adverse events, AEs > Grade 2, laboratory values of special interest and subject deaths.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metastatic Colorectal Cancer (mCRC) Participants | Metastatic colorectal cancer (mCRC) patients who underwent at least 1 (and 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. | 34 | 34 | 31 | 34 | 34 | 34 |
| EG001 | Pancreatic Cancer Participants | Pancreatic cancer patients who underwent at least 1 (and up to 3) implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. | 24 | 24 | 20 | 24 | 24 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Adominal pain | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal ascites | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Peritoneal abscess | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Cardiac enzymes increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| Malignant neoplasm of paraurethral glands | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Urethral obstruction | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Inferior vena caval occlusion | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Diarroea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Flatulance | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal pain discomfort | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal rigidity | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Incision site complication | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Aspratate aminotransferase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypoaethesia | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
|
Limitations of this study include the lack of non-macrobead implanted comparator groups for pancreatic and mCRC subjects, the small sample sizes of both groups, the limited number of subjects with >1 implant and the potential for various biases due to the non-randomized study design.
Sponsor retains the first right for scientific disclosure of study results. PI may draft a study results disclosure for scientific publication following the earlier of sponsor's disclosure or 12 months after study completion at all sites. Sponsor has 60 days to review PI's draft for patentable subject matter or confidential information. PI will delete any confidential information and delay any disclosure for another 60 days for sponsor to secure proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Betty-Jane Sloan, Clinical Research Manager | The Rogosin Institute | 646-317-0701 | bjsloan@nyp.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2014 | Dec 29, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2015 | Dec 29, 2020 | ICF_002.pdf |
| Male |
|
| Black |
|
| Hispanic |
|
| Asian |
|
| Native American |
|
| Other |
|
|
mCRC participants with decreased/necrosis observed based on imaging results [Tumor measurements/SUV max]. |
| OG002 | Increased | mCRC participants with increased SUVmax, tumor measurement based on imaging results. |
|
|
| OG003 | mCRC: Non-responder | Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value. |
|
|
| OG003 | Pancreatic Cancer: Non-responder | Participants with pancreatic cancer whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value. |
|
|
| Implant 1: Day 60 |
CRP levels at day 60 after first implantation. |
| OG004 | Implant 2: Day 0 | CRP levels at day 0 of second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | CRP levels at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | CRP levels at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | CRP levels at day 60 after second implantation. |
|
|
| OG003 |
| Implant 1: Day 60 |
CRP levels at day 60 after first implantation. |
| OG004 | Implant 2: Day 0 | CRP levels at day 0 of second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | CRP levels at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | CRP levels at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | CRP levels at day 60 after second implantation. |
|
|
| Implant 1: Day 60 |
ESR at day 60 after first implantation. |
| OG004 | Implant 2: Day 0 | ESR at day 0 of second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | ESR at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | ESR at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | ESR at day 60 after second implantation. |
|
|
| Implant 1: Day 60 |
ESR at day 60 after first implantation. |
| OG004 | Implant 2: Day 0 | ESR at day 0 of second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | ESR at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | ESR at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | ESR at day 60 after second implantation. |
|
|
| OG003 | Implant 1: Day 60 | CA 125 levels at day 60 after first implantation. |
| OG004 | Implant 2: Day 0 | CA 125 levels at day 0 of second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | CA 125 levels at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | CA 125 levels at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | CA 125 levels at day 60 after second implantation. |
|
|
| OG003 | Implant 1: Day 60 | CA 125 levels at day 60 after first implantation. |
| OG004 | Implant 2: Day 0 | CA 125 levels at day 0 of second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | CA 125 levels at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | CA 125 levels at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | CA 125 levels at day 60 after second implantation. |
|
|
| OG002 | Implant 1: Day 30 | ECOG score at day 30 after first implantation. |
| OG003 | Implant 1: Day 60 | ECOG score at day 60 after first implantation. |
| OG004 | Implant 2: Day 0 | ECOG score at pre-screening for second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | ECOG score at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | ECOG score at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | ECOG score at day 60 after second implantation. |
|
|
| OG001 | Implant 1: Day 14 | ECOG score at day 14 after first implantation. |
| OG002 | Implant 1: Day 30 | ECOG score at day 30 after first implantation. |
| OG003 | Implant 1: Day 60 | ECOG score at day 60 after first implantation. |
| OG004 | Implant 2: Day 0 | ECOG score at pre-screening for second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | ECOG score at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | ECOG score at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | ECOG score at day 60 after second implantation. |
|
|
| OG001 | Implant 1: Day 14 | KPS score at day 14 after first implantation. |
| OG002 | Implant 1: Day 30 | KPS score at day 30 after first implantation. |
| OG003 | Implant 1: Day 60 | KPS score at day 60 after first implantation. |
| OG004 | Implant 2: Day 0 | KPS score at pre-screening for second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | KPS score at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | ECOG score at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | ECOG score at day 60 after second implantation. |
|
|
| OG001 | Implant 1: Day 14 | KPS score at day 14 after first implantation. |
| OG002 | Implant 1: Day 30 | KPS score at day 30 after first implantation. |
| OG003 | Implant 1: Day 60 | KPS score at day 60 after first implantation. |
| OG004 | Implant 2: Day 0 | KPS score at pre-screening for second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | KPS score at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | KPS score at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | KPS score at day 60 after second implantation. |
|
|
| Implant 1: Day 14 |
Global health status score at day 14 after first implantation. |
| OG002 | Implant 1: Day 30 | Global health status score at day 30 after first implantation. |
| OG003 | Implant 1: Day 60 | Global health status score at day 60 after first implantation. |
| OG004 | Implant 2: Day 0 | Global health status score at pre-screening for second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | Global health status score at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | Global health status score at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | Global health status score at day 60 after second implantation. |
|
|
| Implant 1: Day 14 |
Global health status score at day 14 after first implantation. |
| OG002 | Implant 1: Day 30 | Global health status score at day 30 after first implantation. |
| OG003 | Implant 1: Day 60 | Global health status score at day 60 after first implantation. |
| OG004 | Implant 2: Day 0 | Global health status score at pre-screening for second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | Global health status score at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | Global health status score at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | Global health status score at day 60 after second implantation. |
|
|
| OG002 | Implant 1: Day 60 | EORTC/Physical functioning score at day 60 after first implantation. |
| OG003 | Implant 2: Day 0 | EORTC/Physical functioning score at pre-screening for second implantation (day 90 following first implantation). |
| OG004 | Implant 2: Day 30 | EORTC/Physical functioning score at day 30 after second implantation. |
| OG005 | Implant 2: Day 60 | EORTC/Physical functioning score at day 60 after second implantation. |
|
|
| OG002 | Implant 1: Day 60 | EORTC/Physical functioning score at day 60 after first implantation. |
| OG003 | Implant 2: Day 0 | EORTC/Physical functioning score at pre-screening for second implantation (day 90 following first implantation). |
| OG004 | Implant 2: Day 30 | EORTC/Physical functioning score at day 30 after second implantation. |
| OG005 | Implant 2: Day 60 | EORTC/Physical functioning score at day 60 after second implantation. |
|
|
| OG002 | Implant 1: Day 60 | EORTC/Role functioning score at day 60 after first implantation. |
| OG003 | Implant 2: Day 0 | EORTC/Role functioning score at pre-screening for second implantation (day 90 following first implantation). |
| OG004 | Implant 2: Day 30 | EORTC/Role functioning score at day 30 after second implantation. |
| OG005 | Implant 2: Day 60 | EORTC/Role functioning score at day 60 after second implantation. |
|
|
| OG002 | Implant 1: Day 60 | EORTC/Role functioning score at day 60 after first implantation. |
| OG003 | Implant 2: Day 0 | EORTC/Role functioning score at pre-screening for second implantation (day 90 following first implantation). |
| OG004 | Implant 2: Day 30 | EORTC/Role functioning score at day 30 after second implantation. |
| OG005 | Implant 2: Day 60 | EORTC/Role functioning score at day 60 after second implantation. |
|
|
| OG002 | Implant 1: Day 60 | EORTC/Role functioning score at day 60 after first implantation. |
| OG003 | Implant 2: Day 0 | EORTC/Emotional functioning score at pre-screening for second implantation (day 90 following first implantation). |
| OG004 | Implant 2: Day 30 | EORTC/Emotional functioning score at day 30 after second implantation. |
| OG005 | Implant 2: Day 60 | EORTC/Emotional functioning score at day 60 after second implantation. |
|
|
| OG002 | Implant 1: Day 60 | EORTC/Role functioning score at day 60 after first implantation. |
| OG003 | Implant 2: Day 0 | EORTC/Emotional functioning score at pre-screening for second implantation (day 90 following first implantation). |
| OG004 | Implant 2: Day 30 | EORTC/Emotional functioning score at day 30 after second implantation. |
| OG005 | Implant 2: Day 60 | EORTC/Emotional functioning score at day 60 after second implantation. |
|
|
| OG002 | Implant 1: Day 60 | EORTC/Cognitive functioning score at day 60 after first implantation. |
| OG003 | Implant 2: Day 0 | EORTC/Cognitive functioning score at pre-screening for second implantation (day 90 following first implantation). |
| OG004 | Implant 2: Day 30 | EORTC/Cognitive functioning score at day 30 after second implantation. |
| OG005 | Implant 2: Day 60 | EORTC/Cognitive functioning score at day 60 after second implantation. |
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| OG002 | Implant 1: Day 60 | EORTC/Cognitive functioning score at day 60 after first implantation. |
| OG003 | Implant 2: Day 0 | EORTC/Cognitive functioning score at pre-screening for second implantation (day 90 following first implantation). |
| OG004 | Implant 2: Day 30 | EORTC/Cognitive functioning score at day 30 after second implantation. |
| OG005 | Implant 2: Day 60 | EORTC/Cognitive functioning score at day 60 after second implantation. |
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| OG002 | Implant 1: Day 60 | EORTC/Social functioning score at day 60 after first implantation. |
| OG003 | Implant 2: Day 0 | EORTC/Social functioning score at pre-screening for second implantation (day 90 following first implantation). |
| OG004 | Implant 2: Day 30 | EORTC/Social functioning score at day 30 after second implantation. |
| OG005 | Implant 2: Day 60 | EORTC/Social functioning score at day 60 after second implantation. |
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| OG002 | Implant 1: Day 60 | EORTC/Social functioning score at day 60 after first implantation. |
| OG003 | Implant 2: Day 0 | EORTC/Social functioning score at pre-screening for second implantation (day 90 following first implantation). |
| OG004 | Implant 2: Day 30 | EORTC/Social functioning score at day 30 after second implantation. |
| OG005 | Implant 2: Day 60 | EORTC/Social functioning score at day 60 after second implantation. |
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| OG004 | Implant 2: Day 0 | Pain assessment score at pre-screening for second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | Pain assessment score at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | EORTC/Pain assessment score at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | Pain assessment score at day 60 after second implantation. |
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| OG004 | Implant 2: Day 0 | Pain assessment score at pre-screening for second implantation (day 90 following first implantation). |
| OG005 | Implant 2: Day 14 | Pain assessment score at day 14 after second implantation. |
| OG006 | Implant 2: Day 30 | EORTC/Pain assessment score at day 30 after second implantation. |
| OG007 | Implant 2: Day 60 | Pain assessment score at day 60 after second implantation. |
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