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NCT02638090 · ClinicalTrials.gov registry record · Phase 1
Pembro and Vorinostat for Patients With Stage IV Non-small Cell Lung Cancer (NSCLC)
A Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT02638090: Active Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02638090 is a Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 120 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02638090, a Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this study is to see whether the combination of two drugs called pembrolizumab and vorinostat can help people with advanced lung cancer. Researchers also want to find out if the combination of pembrolizumab and vorinostat is safe and tolerable. This study will compare the effects of the combination of two drugs called pembrolizumab and vorinostat with the effects of pembrolizumab alone. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and lung cancer and vorinostat to treat some forms of blood and lymph node cancers.
Primary Outcome
The maximum tolerated dose (MTD) corresponding to a risk of dose limiting toxicity (DLT) occurring in 30% of patients. DLTs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03). A DLT will be defined as any Grade 3 or higher toxicity that occurs during the DLT evaluation period. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Vorinostat
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2016-03-22 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
What the registry record for NCT02638090 still lists
NCT02638090 is an interventional study that assigns participants to a tested intervention. The registered 120 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 (82% lower).
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02638090 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02638090 about?
NCT02638090 is a clinical study titled "Pembro and Vorinostat for Patients With Stage IV Non-small Cell Lung Cancer (NSCLC)". The main purpose of this study is to see whether the combination of two drugs called pembrolizumab and vorinostat can help people with advanced lung cancer. Researchers also want to find out if the combination of pembrolizumab and vorinostat is safe and tolerable. This study will compare the effects...
What is the current status of trial NCT02638090?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2016-03-22. Estimated completion is 2026-07.
What conditions does trial NCT02638090 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Lung Cancer.
What interventions are being tested in trial NCT02638090?
The interventions under investigation include: Pembrolizumab (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT02638090?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02638090 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02638090's enrollment target sits among peer trials
120 219th of 454 higher than 234 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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