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NCT00697346 · ClinicalTrials.gov registry record · Phase 1
Study of MLN8237 in Participants With Advanced Hematological Malignancies
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT00697346: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT00697346 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 58 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
NCT00697346, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, phase 1 study of MLN8237 in participants with advanced hematological malignancies for whom there are limited standard treatment options.
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 th
Interventions
- DRUG Alisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2008-07-11 |
| Est. Completion | 2016-10-19 |
| Phase | Phase 1 |
What the finished NCT00697346 record still lists
NCT00697346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 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 1 intervention - of which Alisertib is the first listed.
NCT00697346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00697346 about?
NCT00697346 is a clinical study titled "Study of MLN8237 in Participants With Advanced Hematological Malignancies". This is an open-label, multicenter, phase 1 study of MLN8237 in participants with advanced hematological malignancies for whom there are limited standard treatment options.
What is the current status of trial NCT00697346?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2008-07-11. Estimated completion is 2016-10-19.
What interventions are being tested in trial NCT00697346?
The interventions under investigation include: Alisertib (DRUG).
Who is sponsoring clinical trial NCT00697346?
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 NCT00697346's enrollment target sits among peer trials
58 895th of 2000 higher than 1,100 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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