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NCT02437136 · ClinicalTrials.gov registry record · Phase 1
Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC)
A Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Syndax Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 191
- Enrollment target
- 11
- Study locations
NCT02437136: Completed Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Syndax Pharmaceuticals.
NCT02437136 is a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma that has completed, run by Syndax Pharmaceuticals. The registered enrollment target is 191 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (71% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02437136, a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, has completed, sponsored by Syndax Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 191 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in participants with NSCLC. Additionally, the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in participants with NSCLC, Melanoma, and Mismatch-Repair Proficient CRC.
Primary Outcome
The ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR). CR: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 millimeters (mm). PR: Sum of the diameters (longest for non-nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. For purposes of analysis, 1 month was considered to be 30.43
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG entinostat
Study Locations (11)
Maryland
- University of Maryland, Marlene and Stewart Greenbaum Cancer Center - Baltimore
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
New York
- Roswell Park Cancer Institute - Buffalo
- Memorial Sloan Kettering Cancer Center - New York
Tennessee
- Sarah Cannon Research Institute - Nashville
- Vanderbilt University Medical Center - Nashville
Connecticut
- Yale University - New Haven
Georgia
- Emory University - Atlanta
Massachusetts
- Dana Farber Cancer Institution - Boston
North Carolina
- The University of North Carolina at Chapel Hill - Chapel Hill
Pennsylvania
- St Luke's University Health Network - Easton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2015-08-26 |
| Est. Completion | 2022-09-29 |
| Phase | Phase 1 |
What the finished NCT02437136 record still lists
NCT02437136 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (71% lower).
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which pembrolizumab is the first listed.
NCT02437136 lists 11 locations in 8 states (Maryland, New York, Tennessee).
Frequently Asked Questions
What is clinical trial NCT02437136 about?
NCT02437136 is a clinical study titled "Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC)". The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in participants with NSCLC. Additionally, the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in participants with NSCLC, Melanom...
What is the current status of trial NCT02437136?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 191 participants. The study started on 2015-08-26. Estimated completion is 2022-09-29.
What conditions does trial NCT02437136 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Melanoma, Mismatch Repair-Proficient Colorectal Cancer.
What interventions are being tested in trial NCT02437136?
The interventions under investigation include: pembrolizumab (DRUG), entinostat (DRUG).
Who is sponsoring clinical trial NCT02437136?
This trial is sponsored by Syndax Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02437136 being conducted?
This trial has 11 study locations across Connecticut, Georgia, Maryland, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02437136's enrollment target sits among peer trials
191 170th of 454 higher than 284 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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