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NCT02584647 · ClinicalTrials.gov registry record · Phase 1
PLX3397 Plus Sirolimus in Unresectable Sarcoma and Malignant Peripheral Nerve Sheath Tumors
A Phase 1 study, sponsored by Gulam Manji.
- Terminated
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT02584647: Clinical Trial Phase 1 study, sponsored by Gulam Manji.
NCT02584647 is a Phase 1 study that was terminated before completion, run by Gulam Manji. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02584647, a Phase 1 study, was terminated before completion, sponsored by Gulam Manji.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if treatment with PLX3397 and Sirolimus will be tolerated and result in shrinking of the cancer or stopping the cancer from growing. In the phase I portion, the maximum tolerate dose of the study drug will be determined. In the Phase II portion, progression free survival will be assessed at the dose level found in Phase I. Participants will continue to take the study drug until they experience an unacceptable side effect or their disease progresses. Funding Source - FDA OOPD
Primary Outcome
The highest dose of a drug or treatment that does not cause unacceptable side effects, which will be used in Phase 2.
Interventions
- DRUG sirolimus
- DRUG PLX3397
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2015-11-04 |
| Est. Completion | 2024-10-01 |
| Phase | Phase 1 |
Why NCT02584647 stopped before completion
NCT02584647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which sirolimus is the first listed.
NCT02584647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02584647 about?
NCT02584647 is a clinical study titled "PLX3397 Plus Sirolimus in Unresectable Sarcoma and Malignant Peripheral Nerve Sheath Tumors". The purpose of this study is to determine if treatment with PLX3397 and Sirolimus will be tolerated and result in shrinking of the cancer or stopping the cancer from growing. In the phase I portion, the maximum tolerate dose of the study drug will be determined. In the Phase II portion, progression ...
What is the current status of trial NCT02584647?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2015-11-04. Estimated completion is 2024-10-01.
What interventions are being tested in trial NCT02584647?
The interventions under investigation include: sirolimus (DRUG), PLX3397 (DRUG).
Who is sponsoring clinical trial NCT02584647?
This trial is sponsored by Gulam Manji, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02584647's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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