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NCT01053013 · ClinicalTrials.gov registry record · Phase 2
Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic/Colorectal Cancer
A Phase 2 study of Colorectal Cancer Metastatic and Pancreatic Adenocarcinoma Metastatic, sponsored by The Rogosin Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT01053013: Completed Phase 2 study of Colorectal Cancer Metastatic and Pancreatic Adenocarcinoma Metastatic, sponsored by The Rogosin Institute.
NCT01053013 is a Phase 2 study of Colorectal Cancer Metastatic and Pancreatic Adenocarcinoma Metastatic that has completed, run by The Rogosin Institute. The registered enrollment target is 58 participants, below the 202-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01053013, a Phase 2 study of Colorectal Cancer Metastatic and Pancreatic Adenocarcinoma Metastatic, has completed, sponsored by The Rogosin Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a clinical research study of an investigational (FDA BB-IND 10091) treatment for patients with pancreatic cancer (all stages) and advanced colorectal cancer that no longer responds to standard therapies. The treatment is being evaluated for its effect on tumor growth. It consists of the placement (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA macrobeads). The cells in the macrobeads produce substances that have been shown to slow or stop the growth of tumors in experimental animals and veterinary patients. It has been tested in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II studies in patients with colorectal, pancreatic or prostate cancers are in progress.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL RENCA macrobeads
Study Locations (1)
New York
- Weill Cornell Medical Center / The Rogosin Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2010-04-15 |
| Est. Completion | 2016-04-16 |
| Phase | Phase 2 |
What the finished NCT01053013 record still lists
NCT01053013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 202-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target (71% lower).
The record links to 3 conditions, with Colorectal Cancer Metastatic appearing as the primary indexed condition, and to 1 intervention - of which RENCA macrobeads is the first listed.
NCT01053013 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01053013 about?
NCT01053013 is a clinical study titled "Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic/Colorectal Cancer". 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 pla...
What is the current status of trial NCT01053013?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2010-04-15. Estimated completion is 2016-04-16.
What conditions does trial NCT01053013 study?
This clinical trial studies the following conditions: Colorectal Cancer Metastatic, Pancreatic Adenocarcinoma Metastatic, Pancreatic Adenocarcinoma Non-resectable.
What interventions are being tested in trial NCT01053013?
The interventions under investigation include: RENCA macrobeads (BIOLOGICAL).
Who is sponsoring clinical trial NCT01053013?
This trial is sponsored by The Rogosin Institute, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01053013 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01053013's enrollment target sits among peer trials
58 8th of 18 higher than 11 of 18 other Colorectal Cancer Metastatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer Metastatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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