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NCT01991379 · ClinicalTrials.gov registry record · Phase 1
MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)
A Phase 1 study of Gastrointestinal Stromal Tumor (GIST), sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT01991379: Active Phase 1 study of Gastrointestinal Stromal Tumor (GIST), sponsored by Memorial Sloan Kettering Cancer Center.
NCT01991379 is a Phase 1 study of Gastrointestinal Stromal Tumor (GIST) that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 75 participants, below the 182-participant average among 6 other Gastrointestinal Stromal Tumor (GIST) trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01991379, a Phase 1 study of Gastrointestinal Stromal Tumor (GIST), is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the effects, good and/or bad, of MEK162 and imatinib on the patient and on Gastrointestinal Stromal Tumor (GIST). Funding Source - FDA OOPD, Array/Pfizer
Primary Outcome
The first three patients will be enrolled at Dose Level 1. If dose level 1 is not found to be tolerable, then the next cohort will be enrolled at dose level -1. If dose level -1 is not found to be tolerable, then the study may be terminated based on discussions with the sponsor and the combination may be deemed intolerable. If 0/3 patients or 1/6 patients experience a DLT on dose level 2, this will be the RP2D.
Conditions Studied
Interventions
- OTHER Blood draws
- PROCEDURE biopsy
- DRUG MEK162
- DRUG Imatinib Mesylate (Gleevec®; STI571; NSC #716051)
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2013-11 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
What the registry record for NCT01991379 still lists
NCT01991379 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 182-participant average among 6 other Gastrointestinal Stromal Tumor (GIST) trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Gastrointestinal Stromal Tumor (GIST) appearing as the primary indexed condition, and to 4 interventions - of which Blood draws is the first listed.
NCT01991379 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01991379 about?
NCT01991379 is a clinical study titled "MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)". The purpose of this study is to evaluate the effects, good and/or bad, of MEK162 and imatinib on the patient and on Gastrointestinal Stromal Tumor (GIST). Funding Source - FDA OOPD, Array/Pfizer
What is the current status of trial NCT01991379?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2013-11. Estimated completion is 2026-11.
What conditions does trial NCT01991379 study?
This clinical trial studies the following conditions: Gastrointestinal Stromal Tumor (GIST).
What interventions are being tested in trial NCT01991379?
The interventions under investigation include: Blood draws (OTHER), biopsy (PROCEDURE), MEK162 (DRUG), Imatinib Mesylate (Gleevec®; STI571; NSC #716051) (DRUG).
Who is sponsoring clinical trial NCT01991379?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01991379 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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