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NCT00445458 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
A Phase 1 study, sponsored by Puma Biotechnology.
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
NCT00445458: Completed Phase 1 study, sponsored by Puma Biotechnology.
NCT00445458 is a Phase 1 study that has completed, run by Puma Biotechnology. The registered enrollment target is 110 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00445458, a Phase 1 study, has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
Study Summary
The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.
Primary Outcome
Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
Interventions
- DRUG Paclitaxel
- DRUG HKI-272
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2007-09-11 |
| Est. Completion | 2018-02-07 |
| Phase | Phase 1 |
What the finished NCT00445458 record still lists
NCT00445458 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% higher).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT00445458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00445458 about?
NCT00445458 is a clinical study titled "A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer". The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.
What is the current status of trial NCT00445458?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2007-09-11. Estimated completion is 2018-02-07.
What interventions are being tested in trial NCT00445458?
The interventions under investigation include: Paclitaxel (DRUG), HKI-272 (DRUG).
Who is sponsoring clinical trial NCT00445458?
This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00445458's enrollment target sits among peer trials
110 514th of 2000 higher than 1,479 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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