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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 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.

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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.

Conditions Studied

Colorectal Cancer Metastatic Pancreatic Adenocarcinoma Metastatic Pancreatic Adenocarcinoma Non-resectable

Interventions

  • BIOLOGICAL RENCA macrobeads

Study Locations (1)

New York

  • Weill Cornell Medical Center / The Rogosin Institute - New York

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2010-04-15
Est. Completion 2016-04-16
Phase Phase 2

Sponsor

The Rogosin Institute

21 total trials

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What the Registry Record Tells You About NCT01053013

The ClinicalTrials.gov registry entry for NCT01053013 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 202-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target (71% lower). The listed sponsor is The Rogosin Institute, which has 21 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.