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NCT00319254 · ClinicalTrials.gov registry record · Phase 2

Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer

A Phase 2 study, sponsored by Pfizer.

Completed
Registry status
Phase 2
Development phase
75
Enrollment target

NCT00319254: Completed Phase 2 study, sponsored by Pfizer.

NCT00319254 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00319254, a Phase 2 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 2
Development phase
75 participants
Enrollment target

Study Summary

The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.

Primary Outcome

PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from death case report forms (CRFs). Percentage of participants who had no

Interventions

  • DRUG SKI-606 (Bosutinib)

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2006-05
Est. Completion 2009-02
Phase Phase 2
Pfizer

1,845 total trials

What the finished NCT00319254 record still lists

NCT00319254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).

The record links to 0 conditions, and to 1 intervention - of which SKI-606 (Bosutinib) is the first listed.

NCT00319254 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00319254 about?

NCT00319254 is a clinical study titled "Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer". The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.

What is the current status of trial NCT00319254?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2006-05. Estimated completion is 2009-02.

What interventions are being tested in trial NCT00319254?

The interventions under investigation include: SKI-606 (Bosutinib) (DRUG).

Who is sponsoring clinical trial NCT00319254?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00319254's enrollment target sits among peer trials

75 900th of 2000 higher than 1,081 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 NCT00319254, the US trial registry maintained by the National Library of Medicine. NCT00319254 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.