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NCT00924352 · ClinicalTrials.gov registry record · Phase 1
Trial of Dasatinib Plus Ixabepilone in 2nd or 3rd Line Metastatic Breast Cancer
A Phase 1 study, sponsored by Accelerated Community Oncology Research Network.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT00924352: Completed Phase 1 study, sponsored by Accelerated Community Oncology Research Network.
NCT00924352 is a Phase 1 study that has completed, run by Accelerated Community Oncology Research Network. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00924352, a Phase 1 study, has completed, sponsored by Accelerated Community Oncology Research Network.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
The primary objective for the Phase I portion of the study is to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) and for the Phase II portion of the study is to evaluate progression free survival (PFS). Secondary objectives are response rate, clinical benefit rate, and overall toxicity.
Primary Outcome
The MTD of dasatinib (taken daily, continuously) when given in combination with ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT.
Interventions
- DRUG Dasatinib
- DRUG Ixabepilone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2009-06 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT00924352 record still lists
NCT00924352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Dasatinib is the first listed.
NCT00924352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00924352 about?
NCT00924352 is a clinical study titled "Trial of Dasatinib Plus Ixabepilone in 2nd or 3rd Line Metastatic Breast Cancer". The primary objective for the Phase I portion of the study is to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) and for the Phase II portion of the study is to evaluate progression free survival (PFS). Secondary objectives are response rate, clinical benefit rate, and...
What is the current status of trial NCT00924352?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2009-06. Estimated completion is 2013-10.
What interventions are being tested in trial NCT00924352?
The interventions under investigation include: Dasatinib (DRUG), Ixabepilone (DRUG).
Who is sponsoring clinical trial NCT00924352?
This trial is sponsored by Accelerated Community Oncology Research Network, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00924352's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 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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