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NCT00962091 · ClinicalTrials.gov registry record · Phase 1
Study of MLN8237 in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
NCT00962091: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT00962091 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 53 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00962091, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
Study Summary
The purposes of this study were to estimate the relative (Rel) bioavailability (BA) of an oral solution (OS) formulation of alisertib in reference to a powder-in-capsule (PIC) formulation, to characterize the effect of food on the single-dose pharmacokinetics (PK) of alisertib OS and enteric-coated tablets (ECT), to characterize the multiple-dose safety, tolerability, and steady-state PK of alisertib administered as an OS, and to characterize the multiple-dose safety and tolerability of alisertib administered as an ECT.
Primary Outcome
Dose normalized Cmax was obtained using Cmax divided by alisertib dose in milligrams to provide values adjusted to a 1 mg alisertib dose.
Interventions
- DRUG Alisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2009-09-25 |
| Est. Completion | 2014-07-01 |
| Phase | Phase 1 |
What the finished NCT00962091 record still lists
NCT00962091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 1 intervention - of which Alisertib is the first listed.
NCT00962091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00962091 about?
NCT00962091 is a clinical study titled "Study of MLN8237 in Participants With Advanced Solid Tumors". The purposes of this study were to estimate the relative (Rel) bioavailability (BA) of an oral solution (OS) formulation of alisertib in reference to a powder-in-capsule (PIC) formulation, to characterize the effect of food on the single-dose pharmacokinetics (PK) of alisertib OS and enteric-coated ...
What is the current status of trial NCT00962091?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2009-09-25. Estimated completion is 2014-07-01.
What interventions are being tested in trial NCT00962091?
The interventions under investigation include: Alisertib (DRUG).
Who is sponsoring clinical trial NCT00962091?
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 NCT00962091's enrollment target sits among peer trials
53 948th of 2000 higher than 1,045 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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