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NCT01639131 · ClinicalTrials.gov registry record · Phase 2

Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Metastatic Colorectal Adenocarcinoma

A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Terminated
Registry status
Phase 2
Development phase
6
Enrollment target

NCT01639131: Clinical Trial Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT01639131 is a Phase 2 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01639131, a Phase 2 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

TERMINATED
Registry status
Phase 2
Development phase
6 participants
Enrollment target

Study Summary

The primary goal of the trail was to determine the efficacy of combining Gemcitabine and Docetaxel in treatment of metastatic colorectal cancer with CHFR and/or Microsatellite Instability (MSI) phenotype.

Primary Outcome

The Response Rate is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

Interventions

  • DRUG Docetaxel
  • DRUG Gemcitabine
  • DRUG Filgrastim or Pegfilgrastim

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2012-09-10
Est. Completion 2019-03-11
Phase Phase 2

Why NCT01639131 stopped before completion

NCT01639131 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.

NCT01639131 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01639131 about?

NCT01639131 is a clinical study titled "Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Metastatic Colorectal Adenocarcinoma". The primary goal of the trail was to determine the efficacy of combining Gemcitabine and Docetaxel in treatment of metastatic colorectal cancer with CHFR and/or Microsatellite Instability (MSI) phenotype.

What is the current status of trial NCT01639131?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2012-09-10. Estimated completion is 2019-03-11.

What interventions are being tested in trial NCT01639131?

The interventions under investigation include: Docetaxel (DRUG), Gemcitabine (DRUG), Filgrastim or Pegfilgrastim (DRUG).

Who is sponsoring clinical trial NCT01639131?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01639131's enrollment target sits among peer trials

6 1996th of 2000 higher than 1 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 NCT01639131, the US trial registry maintained by the National Library of Medicine. NCT01639131 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.