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NCT01637961 · ClinicalTrials.gov registry record · Phase 2
Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT01637961: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01637961 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01637961, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
This phase II trial studies how well alisertib works in treating patients with leiomyosarcoma of the uterus that has come back or persistent. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Whether or not the patient survived progression-free for at least 6 months. 90% confidence interval (Bonferroni Corrected). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Alisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2012-08 |
| Est. Completion | 2017-02-11 |
| Phase | Phase 2 |
What the finished NCT01637961 record still lists
NCT01637961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01637961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01637961 about?
NCT01637961 is a clinical study titled "Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus". This phase II trial studies how well alisertib works in treating patients with leiomyosarcoma of the uterus that has come back or persistent. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
What is the current status of trial NCT01637961?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2012-08. Estimated completion is 2017-02-11.
What interventions are being tested in trial NCT01637961?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Alisertib (DRUG).
Who is sponsoring clinical trial NCT01637961?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01637961's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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