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NCT02232152 · ClinicalTrials.gov registry record · Phase 1

CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

A Phase 1 study of Recurrent Colon Cancer and Recurrent Rectal Cancer, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target
1
Study location

NCT02232152 is a Phase 1 study of Recurrent Colon Cancer and Recurrent Rectal Cancer that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 19 participants, below the 29-participant average among 10 other Recurrent Colon Cancer trials with a reported enrollment target (34% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02232152, a Phase 1 study of Recurrent Colon Cancer and Recurrent Rectal Cancer, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target
1
Study location

Study Summary

This pilot phase I trial studies the side effects and best dose of CPI-613 when given together with fluorouracil in treating patients with colorectal cancer that has spread to other parts of the body and cannot be removed by surgery. CPI-613 may kill tumor cells by turning off their mitochondria. Mitochondria are used by tumor cells to produce energy and are the building blocks needed to make more tumor cells. By shutting off these mitochondria, CPI-613 deprives the tumor cells of energy and other supplies that they need to survive and grow in the body. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CPI-613 with fluorouracil may kill more tumor cells.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG fluorouracil
  • OTHER pharmacological study
  • DRUG 6,8-bis(benzylthio)octanoic acid

Study Locations (1)

North Carolina

  • Comprehensive Cancer Center of Wake Forest University - Winston-Salem

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2015-01-06
Est. Completion 2023-01-11
Phase Phase 1

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT02232152

The ClinicalTrials.gov registry entry for NCT02232152 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 29-participant average among 10 other Recurrent Colon Cancer trials with a reported enrollment target (34% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Recurrent Colon Cancer appearing as the primary indexed condition, and to 4 interventions - of which laboratory biomarker analysis is the first listed.

NCT02232152 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT02232152 about?

NCT02232152 is a clinical study titled "CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery". This pilot phase I trial studies the side effects and best dose of CPI-613 when given together with fluorouracil in treating patients with colorectal cancer that has spread to other parts of the body and cannot be removed by surgery. CPI-613 may kill tumor cells by turning off their mitochondria. Mi...

What is the current status of trial NCT02232152?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2015-01-06. Estimated completion is 2023-01-11.

What conditions does trial NCT02232152 study?

This clinical trial studies the following conditions: Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IIIA Colon Cancer, Mucinous Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Colon.

What interventions are being tested in trial NCT02232152?

The interventions under investigation include: laboratory biomarker analysis (OTHER), fluorouracil (DRUG), pharmacological study (OTHER), 6,8-bis(benzylthio)octanoic acid (DRUG).

Who is sponsoring clinical trial NCT02232152?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02232152 being conducted?

This trial has 1 study location across North Carolina. 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

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