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NCT02303262 · ClinicalTrials.gov registry record · Phase 2
SARC018: A Study of Mocetinostat and Gemcitabine in Patients With Metastatic Leiomyosarcoma
A Phase 2 study of Metastatic Leiomyosarcoma, sponsored by Sarcoma Alliance for Research through Collaboration.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 5
- Study locations
NCT02303262: Completed Phase 2 study of Metastatic Leiomyosarcoma, sponsored by Sarcoma Alliance for Research through Collaboration.
NCT02303262 is a Phase 2 study of Metastatic Leiomyosarcoma that has completed, run by Sarcoma Alliance for Research through Collaboration. The registered enrollment target is 20 participants, below the 51-participant average among 4 other Metastatic Leiomyosarcoma trials with a reported enrollment target (61% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02303262, a Phase 2 study of Metastatic Leiomyosarcoma, has completed, sponsored by Sarcoma Alliance for Research through Collaboration.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is an open-label, multi-center, Phase II trial studying the combination of mocetinostat and gemcitabine in patients who have previously demonstrated disease progression either while, or within six months after, receiving chemotherapy with a gemcitabine-based regimen.
Primary Outcome
Response rate (CR or PR) will be calculated by the number of patients achieving a response divided by the number of patients having been evaluated for response. Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameters of all target lesions.
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Mocetinostat
Study Locations (5)
Massachusetts
- Massachusetts General Hospital/Dana Farber Cancer Institute - Boston
Michigan
- University of Michigan - Ann Arbor
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Ohio State University - Columbus
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-11-12 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT02303262 record still lists
NCT02303262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 51-participant average among 4 other Metastatic Leiomyosarcoma trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Metastatic Leiomyosarcoma appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.
NCT02303262 lists 5 locations in 5 states (Massachusetts, Michigan, New York).
Frequently Asked Questions
What is clinical trial NCT02303262 about?
NCT02303262 is a clinical study titled "SARC018: A Study of Mocetinostat and Gemcitabine in Patients With Metastatic Leiomyosarcoma". This is an open-label, multi-center, Phase II trial studying the combination of mocetinostat and gemcitabine in patients who have previously demonstrated disease progression either while, or within six months after, receiving chemotherapy with a gemcitabine-based regimen.
What is the current status of trial NCT02303262?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2015-11-12. Estimated completion is 2016-12.
What conditions does trial NCT02303262 study?
This clinical trial studies the following conditions: Metastatic Leiomyosarcoma.
What interventions are being tested in trial NCT02303262?
The interventions under investigation include: Gemcitabine (DRUG), Mocetinostat (DRUG).
Who is sponsoring clinical trial NCT02303262?
This trial is sponsored by Sarcoma Alliance for Research through Collaboration, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02303262 being conducted?
This trial has 5 study locations across Massachusetts, Michigan, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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