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NCT02046174 · ClinicalTrials.gov registry record · Phase 2

Open-Label Phase IIb Efficacy Trial of Cancer Macrobeads Compared to Best Supportive Care in Colorectal Cancer Patients

A Phase 2 study, sponsored by The Rogosin Institute.

Completed
Registry status
Phase 2
Development phase
70
Enrollment target

NCT02046174: Completed Phase 2 study, sponsored by The Rogosin Institute.

NCT02046174 is a Phase 2 study that has completed, run by The Rogosin Institute. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02046174, a Phase 2 study, has completed, sponsored by The Rogosin Institute.

COMPLETED
Registry status
Phase 2
Development phase
70 participants
Enrollment target

Study Summary

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

Primary Outcome

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.

Interventions

  • BIOLOGICAL RENCA macrobeads

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2014-04-03
Est. Completion 2018-10-22
Phase Phase 2
The Rogosin Institute

21 total trials

What the finished NCT02046174 record still lists

NCT02046174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 1 intervention - of which RENCA macrobeads is the first listed.

NCT02046174 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02046174 about?

NCT02046174 is a clinical study titled "Open-Label Phase IIb Efficacy Trial of Cancer Macrobeads Compared to Best Supportive Care in Colorectal Cancer Patients". 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 bead...

What is the current status of trial NCT02046174?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2014-04-03. Estimated completion is 2018-10-22.

What interventions are being tested in trial NCT02046174?

The interventions under investigation include: RENCA macrobeads (BIOLOGICAL).

Who is sponsoring clinical trial NCT02046174?

This trial is sponsored by The Rogosin Institute, which has 21 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02046174's enrollment target sits among peer trials

70 937th of 2000 higher than 1,036 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02046174, the US trial registry maintained by the National Library of Medicine. NCT02046174 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.