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NCT01482962 · ClinicalTrials.gov registry record · Phase 3
Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma
A Phase 3 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 271
- Enrollment target
NCT01482962: Completed Phase 3 study, sponsored by Millennium Pharmaceuticals.
NCT01482962 is a Phase 3 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 271 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01482962, a Phase 3 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 271 participants
- Enrollment target
Study Summary
This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available.
Primary Outcome
ORR was defined as the percentage of participants who achieve Complete Response (CR) or Partial Response (PR) as assessed by the IRC using International Working Group (IWG) criteria. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites.
Interventions
- DRUG Gemcitabine
- DRUG Alisertib
- DRUG Pralatrexate
- DRUG Romidepsin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 271 participants |
| Start Date | 2012-06-11 |
| Est. Completion | 2017-12-18 |
| Phase | Phase 3 |
What the finished NCT01482962 record still lists
NCT01482962 is an interventional study that assigns participants to a tested intervention. The registered 271 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 4 interventions - of which Gemcitabine is the first listed.
NCT01482962 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01482962 about?
NCT01482962 is a clinical study titled "Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma". This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lympho...
What is the current status of trial NCT01482962?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 271 participants. The study started on 2012-06-11. Estimated completion is 2017-12-18.
What interventions are being tested in trial NCT01482962?
The interventions under investigation include: Gemcitabine (DRUG), Alisertib (DRUG), Pralatrexate (DRUG), Romidepsin (DRUG).
Who is sponsoring clinical trial NCT01482962?
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 NCT01482962's enrollment target sits among peer trials
271 1216th of 2000 higher than 784 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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