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NCT00500903 · ClinicalTrials.gov registry record · Phase 1
A Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 87
- Enrollment target
NCT00500903: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT00500903 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 87 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00500903, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 87 participants
- Enrollment target
Study Summary
To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of MLN8237 when given by mouth (PO) for a minimum of 7 and a maximum of 21 consecutive days, followed by a 14-day recovery period.
Primary Outcome
DLT was evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and was defined as any of the following events related to therapy with alisertib: 1. Grade 4 neutropenia lasting ≥7 consecutive days 2. Grade 4 neutropenia with fever and/or infection 3. Platelet count \<25,000/mm\^3 4. Grade 3 or greater nausea and/or emesis despite use of optimal antiemetic prophylaxis 5. Grade 3 or greater diarrhea despite maximal supportive t
Interventions
- DRUG Alisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2007-05-15 |
| Est. Completion | 2011-02-23 |
| Phase | Phase 1 |
What the finished NCT00500903 record still lists
NCT00500903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 1 intervention - of which Alisertib is the first listed.
NCT00500903 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00500903 about?
NCT00500903 is a clinical study titled "A Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Participants With Advanced Solid Tumors". To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of MLN8237 when given by mouth (PO) for a minimum of 7 and a maximum of 21 consecutive days, followed by a 14-day recovery period.
What is the current status of trial NCT00500903?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 87 participants. The study started on 2007-05-15. Estimated completion is 2011-02-23.
What interventions are being tested in trial NCT00500903?
The interventions under investigation include: Alisertib (DRUG).
Who is sponsoring clinical trial NCT00500903?
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 NCT00500903's enrollment target sits among peer trials
87 651st of 2000 higher than 1,349 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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