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NCT01154816 · ClinicalTrials.gov registry record · Phase 2
Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia
A Phase 2 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
NCT01154816: Completed Phase 2 study, sponsored by Children's Oncology Group.
NCT01154816 is a Phase 2 study that has completed, run by Children's Oncology Group. The registered enrollment target is 118 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01154816, a Phase 2 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
Study Summary
This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
For patients with recurrent solid tumors a patient who experienced a complete or partial response according to RECIST version 1.1 criteria is considered a responder. For patients with recurrent acute lymphoblastic leukemia a patient who experiences a bone marrow evaluation with \< 5% blast cells on morphological evaluation of bone marrow will be considered a responder. For patients with recurrent acute myelogenous leukemia a patient who experiences a complete remission or complete remission with
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Alisertib
- OTHER Pharmacological Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2011-02 |
| Est. Completion | 2019-06-30 |
| Phase | Phase 2 |
What the finished NCT01154816 record still lists
NCT01154816 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01154816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01154816 about?
NCT01154816 is a clinical study titled "Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia". This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
What is the current status of trial NCT01154816?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2011-02. Estimated completion is 2019-06-30.
What interventions are being tested in trial NCT01154816?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Alisertib (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT01154816?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01154816's enrollment target sits among peer trials
118 618th of 2000 higher than 1,378 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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