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NCT01091428 · ClinicalTrials.gov registry record · Phase 2
Alisertib (MLN8237) in Participants With Ovarian, Fallopian Tube or Peritoneal Cancer Preceded by Phase 1 Study of MLN8237 Plus Paclitaxel Treatment of Ovary or Breast Cancer
A Phase 2 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 191
- Enrollment target
NCT01091428: Completed Phase 2 study, sponsored by Millennium Pharmaceuticals.
NCT01091428 is a Phase 2 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 191 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01091428, a Phase 2 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 191 participants
- Enrollment target
Study Summary
This is an open-label, multicenter study with a nonrandomized Phase 1 portion and an open-label, randomized, Phase 2 portion evaluating MLN8237 in combination with weekly paclitaxel in adult female participants with advanced breast cancer (Phase 1 portion only) and recurrent ovarian cancer (both Phase 1 and Phase 2 portions).
Primary Outcome
The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT). DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.02 and was defined as any of the following events: 1. Grade 4 neutropenia and thrombocytopenia lasting ≥7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count \<10,000/mm\^3; 4. Grade 3 thrombocytopenia with bleeding
Interventions
- DRUG Paclitaxel
- DRUG Alisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2010-04-16 |
| Est. Completion | 2017-07-19 |
| Phase | Phase 2 |
What the finished NCT01091428 record still lists
NCT01091428 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT01091428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01091428 about?
NCT01091428 is a clinical study titled "Alisertib (MLN8237) in Participants With Ovarian, Fallopian Tube or Peritoneal Cancer Preceded by Phase 1 Study of MLN8237 Plus Paclitaxel Treatment of Ovary or Breast Cancer". This is an open-label, multicenter study with a nonrandomized Phase 1 portion and an open-label, randomized, Phase 2 portion evaluating MLN8237 in combination with weekly paclitaxel in adult female participants with advanced breast cancer (Phase 1 portion only) and recurrent ovarian cancer (both Pha...
What is the current status of trial NCT01091428?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 191 participants. The study started on 2010-04-16. Estimated completion is 2017-07-19.
What interventions are being tested in trial NCT01091428?
The interventions under investigation include: Paclitaxel (DRUG), Alisertib (DRUG).
Who is sponsoring clinical trial NCT01091428?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01091428's enrollment target sits among peer trials
191 353rd of 2000 higher than 1,648 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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