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NCT00452673 · ClinicalTrials.gov registry record · Phase 1

Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer

A Phase 1 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 1
Development phase
52
Enrollment target

NCT00452673: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.

NCT00452673 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00452673, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 1
Development phase
52 participants
Enrollment target

Study Summary

The purpose of this study is to learn about the safety and efficacy of Dasatinib in combination with Capecitabine for patients with advanced breast cancer, and who have received treatment with a taxane and an anthracycline

Primary Outcome

Safety was assessed from first dose of study drug through at least 30 days after the last dose, until resolution of drug-related toxicity or when toxicity was deemed irreversible, whichever was longer. An adverse event (AE) was considered a dose limiting toxicity (DLT) if it occurred in the first 21 days and was at least possibly related to study drugs and were: Clinically-evident toxicity of Grade \>= 3, or of Grade 2 which required interruption of treatment for \>= 7 days (consecutive or non-c

Interventions

  • DRUG Capecitabine
  • DRUG Dasatinib

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2007-06
Est. Completion 2012-10
Phase Phase 1
Bristol-Myers Squibb

1,025 total trials

What the finished NCT00452673 record still lists

NCT00452673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).

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

NCT00452673 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00452673 about?

NCT00452673 is a clinical study titled "Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer". The purpose of this study is to learn about the safety and efficacy of Dasatinib in combination with Capecitabine for patients with advanced breast cancer, and who have received treatment with a taxane and an anthracycline

What is the current status of trial NCT00452673?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2007-06. Estimated completion is 2012-10.

What interventions are being tested in trial NCT00452673?

The interventions under investigation include: Capecitabine (DRUG), Dasatinib (DRUG).

Who is sponsoring clinical trial NCT00452673?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00452673's enrollment target sits among peer trials

52 956th of 2000 higher than 1,032 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 NCT00452673, the US trial registry maintained by the National Library of Medicine. NCT00452673 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.