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NCT00270907 · ClinicalTrials.gov registry record · Phase 1

CT-2103 in Combination With Gemcitabine in Metastatic Breast Cancer

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT00270907: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT00270907 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00270907, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

The goal of this phase I clinical study is to find the highest safe dose of gemcitabine and CT-2103 that can be given in combination for the treatment of metastatic breast cancer. The safety and effectiveness of this combination will also be studied. This clinical trial will be offered to patients who are being considered for treatment with gemcitabine. Research lab samples and research biopsies will not be requested as part of this study.

Primary Outcome

MTD defined as the level of CT-2103 at which 2 out of 6 patients had dose limiting toxicity (DLT) where the primary DLT events of CT-2103 are uncomplicated neutropenia, febrile neutropenia, and/or grade 3 neuropathy. Assessments during the first cycle of therapy, where cycle is 21 days.

Interventions

  • DRUG Gemcitabine
  • DRUG CT-2103

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2005-12
Est. Completion 2012-10
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00270907 record still lists

NCT00270907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.

NCT00270907 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00270907 about?

NCT00270907 is a clinical study titled "CT-2103 in Combination With Gemcitabine in Metastatic Breast Cancer". The goal of this phase I clinical study is to find the highest safe dose of gemcitabine and CT-2103 that can be given in combination for the treatment of metastatic breast cancer. The safety and effectiveness of this combination will also be studied. This clinical trial will be offered to patients w...

What is the current status of trial NCT00270907?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2005-12. Estimated completion is 2012-10.

What interventions are being tested in trial NCT00270907?

The interventions under investigation include: Gemcitabine (DRUG), CT-2103 (DRUG).

Who is sponsoring clinical trial NCT00270907?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00270907's enrollment target sits among peer trials

13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00270907, the US trial registry maintained by the National Library of Medicine. NCT00270907 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.