Last reviewed · How we verify
Open-Label Phase IIb Efficacy Trial of Cancer Macrobeads Compared to Best Supportive Care in Colorectal Cancer Patients
Phase 2 trial testing RENCA macrobeads in Colorectal Cancers in 70 participants. Completed in 22 October 2018.
| Lead sponsor | The Rogosin Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 3 April 2014 |
| Primary completion | 22 October 2018 |
| Estimated completion | 22 October 2018 |
| Sites | 4 locations across United States |
The Rogosin Institute
18 and older, any sex, with Colorectal Cancers. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary objective of this study was to evaluate the efficacy of RENCA macrobead implantation as assessed by overall survival in subjects with treatment-resistant mCRC.
| Group | Value | 95% CI |
|---|---|---|
| Macrobead Implantation Arm | 9.25 | 6.03 – 11.44 |
The Eastern Cooperative Oncology Group (ECOG) performance scale is a 5-point scale, where 0 denotes perfect health and 5 is death. It is used by clinicians to assess disease progression and how the disease is affecting the daily living abilities of the patient. The ECOG Performance Status scores are defined as follows: * 0: Fully active, able to carry on all pre-disease activities without restriction. * 1: Restricted in physical strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g. light house work, office work). * 2: Ambulatory and capable of all
| Group | Value | 95% CI |
|---|---|---|
| Implant 1: Day 0 | 16 | |
| Implant 1: Day 14 | 5 | |
| Implant 1: Day 30 | 5 | |
| Implant 1: Day 60 | 11 | |
| Implant 2: Day 0 | 5 | |
| Implant 2: Day 14 | 4 | |
| Implant 2: Day 30 | 4 | |
| Implant 2: Day 60 | 4 | |
| Implant 1: Day 0 | 21 | |
| Implant 1: Day 14 | 23 | |
| Implant 1: Day 30 | 23 | |
| Implant 1: Day 60 | 8 | |
| Implant 2: Day 0 | 2 | |
| Implant 2: Day 14 | 3 | |
| Implant 2: Day 30 | 2 | |
| Implant 2: Day 60 | 2 | |
| Implant 1: Day 0 | 4 | |
| Implant 1: Day 14 | 7 | |
| Implant 1: Day 30 | 7 | |
| Implant 1: Day 60 | 7 | |
| Implant 2: Day 0 | 1 | |
| Implant 2: Day 14 | 1 | |
| Implant 2: Day 30 | 1 | |
| Implant 2: Day 60 | 1 | |
| Implant 1: Day 0 | 0 | |
| Implant 1: Day 14 | 2 | |
| Implant 1: Day 30 | 1 | |
| Implant 1: Day 60 | 1 | |
| Implant 2: Day 0 | 0 | |
| Implant 2: Day 14 | 0 | |
| Implant 2: Day 30 | 0 | |
| Implant 2: Day 60 | 0 |
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 per
| Group | Value | 95% CI |
|---|---|---|
| Implant 1: Day 0 | 88.3 | ± 9.6 |
| Implant 1: Day 14 | 82.1 | ± 13.6 |
| Implant 1: Day 30 | 74.3 | ± 23.7 |
| Implant 1: Day 60 | 81.8 | ± 19.1 |
| Implant 2: Day 0 | 94.3 | ± 5.4 |
| Implant 2: Day 14 | 83.3 | ± 16.7 |
| Implant 2: Day 30 | 93.3 | ± 7.7 |
| Implant 2: Day 60 | 91.4 | ± 9.9 |
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 m
| Group | Value | 95% CI |
|---|---|---|
| Implant 1: Day 0 | 68.70 | ± 22.03 |
| Implant 1: Day 14 | 50.21 | ± 24.37 |
| Implant 1: Day 30 | 56.13 | ± 29.61 |
| Implant 1: Day 60 | 69.87 | ± 28.48 |
| Implant 2: Day 0 | 84.38 | ± 17.50 |
| Implant 2: Day 14 | 75.00 | ± 14.77 |
| Implant 2: Day 30 | 83.33 | ± 11.79 |
| Implant 2: Day 60 | 83.33 | ± 26.79 |
TThe 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 tr
| Group | Value | 95% CI |
|---|---|---|
| Implant 1: Day 0 | 80.65 | ± 17.94 |
| Implant 1: Day 14 | 69.57 | ± 24.79 |
| Implant 1: Day 30 | 82.50 | ± 12.96 |
| Implant 1: Day 60 | 83.50 | ± 14.13 |
| Implant 2: Day 0 | 91.67 | ± 9.26 |
| Implant 2: Day 14 | 90.00 | ± 9.26 |
| Implant 2: Day 30 | 92.90 | ± 4.88 |
| Implant 2: Day 60 | 90.00 | ± 6.32 |
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 transformat
| Group | Value | 95% CI |
|---|---|---|
| Implant 1: Day 0 | 81.71 | ± 20.00 |
| Implant 1: Day 14 | 55.56 | ± 32.07 |
| Implant 1: Day 30 | 61.27 | ± 32.75 |
| Implant 1: Day 60 | 74.36 | ± 30.99 |
| Implant 2: Day 0 | 89.58 | ± 15.27 |
| Implant 2: Day 14 | 60.42 | ± 43.59 |
| Implant 2: Day 30 | 85.71 | ± 20.25 |
| Implant 2: Day 60 | 95.24 | ± 12.59 |
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 tra
| Group | Value | 95% CI |
|---|---|---|
| Implant 1: Day 0 | 79.07 | ± 22.06 |
| Implant 1: Day 14 | 72.65 | ± 28.74 |
| Implant 1: Day 30 | 76.23 | ± 27.91 |
| Implant 1: Day 60 | 80.56 | ± 20.79 |
| Implant 2: Day 0 | 86.46 | ± 11.73 |
| Implant 2: Day 14 | 78.13 | ± 19.89 |
| Implant 2: Day 30 | 83.33 | ± 19.84 |
| Implant 2: Day 60 | 88.10 | ± 15.11 |
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
| Group | Value | 95% CI |
|---|---|---|
| Implant 1: Day 0 | 83.74 | ± 16.02 |
| Implant 1: Day 14 | 83.76 | ± 21.46 |
| Implant 1: Day 30 | 85.78 | ± 15.43 |
| Implant 1: Day 60 | 86.54 | ± 16.34 |
| Implant 2: Day 0 | 93.75 | ± 12.40 |
| Implant 2: Day 14 | 90.15 | ± 13.27 |
| Implant 2: Day 30 | 97.62 | ± 6.29 |
| Implant 2: Day 60 | 95.24 | ± 8.13 |
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 transf
| Group | Value | 95% CI |
|---|---|---|
| Implant 1: Day 0 | 76.83 | ± 22.63 |
| Implant 1: Day 14 | 67.52 | ± 33.21 |
| Implant 1: Day 30 | 69.61 | ± 26.74 |
| Implant 1: Day 60 | 78.85 | ± 26.89 |
| Implant 2: Day 0 | 93.75 | ± 8.63 |
| Implant 2: Day 14 | 93.75 | ± 12.40 |
| Implant 2: Day 30 | 88.10 | ± 20.89 |
| Implant 2: Day 60 | 90.48 | ± 13.11 |
Participants were asked to rate their pain on a discrete scale (from 0 = "no pain" to 100 "worst pain imaginable, unbearable"). The worst pain at each time point was used in the analysis.
| Group | Value | 95% CI |
|---|---|---|
| Implant 1: Day 0 | 26.83 | ± 26.58 |
| Implant 1: Day 14 | 52.56 | ± 30.24 |
| Implant 1: Day 30 | 41.18 | ± 30.22 |
| Implant 1: Day 60 | 33.33 | ± 33.67 |
| Implant 2: Day 0 | 16.67 | ± 19.92 |
| Implant 2: Day 14 | 22.92 | ± 19.79 |
| Implant 2: Day 30 | 14.29 | ± 20.25 |
| Implant 2: Day 60 | 14.29 | ± 24.39 |
Tumor markers included serum carcinoembryonic antigen (CEA) and cancer antigen 19-9 (CA 19-9), and were assessed on all participants in the RENCA macrobead implantation arm 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.
| Group | Value | 95% CI |
|---|---|---|
| CEA Only | 6 | |
| CA 19-9 Only | 5 | |
| Both CEA and CA 19-9 | 12 | |
| Non-responder | 18 |
Overall survival (OS) of participants by tumor marker response. A responder is a participant having a decrease from baseline of 20% or more in CEA or CA 19-9 within 90 days of Implant. OS is the time interval between the date of radiographically documented disease progression and the date of death due to any cause. Participants still alive at the end of the study are censored at 22OCT2018.
| Group | Value | 95% CI |
|---|---|---|
| Responder | 10.33 | 7.05 – 11.51 |
| Non-Responder | 6.82 | 3.54 – 14.98 |
Time frame: From date of first macrobead implantation; assessed up to 32 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Macrobead Implantation Arm |
|---|---|---|
| Abdominal pain | Gastrointestinal disorders | — |
| Disease progression | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Pyrexia | General disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Abdominal distension | Gastrointestinal disorders | — |
| Peritonitis | Infections and infestations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Leukocytosis | Blood and lymphatic system disorders | — |
| Tachycardia | Cardiac disorders | — |
| Ascites | Gastrointestinal disorders | — |
| Large intestinal obstruction | Gastrointestinal disorders | — |
| Small intestinal obstruction | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Malaise | General disorders | — |
| Pain | General disorders | — |
| Abdominal abscess | Infections and infestations | — |
| Abdominal infection | Infections and infestations | — |
| Empyema | Infections and infestations | — |
| Influenza | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Spinal column injury | Injury, poisoning and procedural complications | — |
| Activated partial thromboplastin time prolonged | Investigations | — |
| Blood biliriubin increased | Investigations | — |
| Reaction | System | Macrobead Implantation Arm |
|---|---|---|
| Fatigue | General disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Abdominal distension | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Pyrexia | General disorders | — |
| Incision site pain | Injury, poisoning and procedural complications | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Oedema peripheral | General disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Weight decreased | Investigations | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Asthenia | General disorders | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — |
| Headache | Nervous system disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | — |
| Flatulence | Gastrointestinal disorders | — |
| Activated partial thromboplastin time prolonged | Investigations | — |
| Dizziness | Nervous system disorders | — |
| Insomnia | Psychiatric disorders | — |
| Night sweats | Skin and subcutaneous tissue disorders | — |
| Abdominal pain, upper | Gastrointestinal disorders | — |
| Proctalgia | Gastrointestinal disorders | — |
| Chills | General disorders | — |
| Gait disturbance | General disorders | — |
| Urinary tract infection | Infections and infestations | — |
| International normalised ratio increased | Investigations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Muscular weakness | Musculoskeletal and connective tissue disorders | — |
| Lethargy | Nervous system disorders | — |
| Agitation | Psychiatric disorders | — |
| Confusional state | Psychiatric disorders | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Abdominal pain, Disease progression, Nausea, Vomiting, Pyrexia, Anaemia, Abdominal distension, Peritonitis.
Data from ClinicalTrials.gov NCT02046174 adverse events section.
This is a clinical research study of an investigational (FDA IND-BB 10091) treatment for patients with 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
3 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02046174.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing