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NCT04631029 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of an Anti-cancer Drug, Entinostat, to the Usual Chemotherapy and Immunotherapy Treatment (Atezolizumab, Carboplatin and Etoposide) for Previously Untreated Aggressive Lung Cancer That Has Spread
A Phase 1 study of Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
- 5
- Study locations
NCT04631029: Completed Phase 1 study of Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, sponsored by National Cancer Institute (NCI).
NCT04631029 is a Phase 1 study of Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (100% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04631029, a Phase 1 study of Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
- 5
- Study locations
Study Summary
This phase I trial seeks to find out the best dose, possible benefits and/or side effects of entinostat in combination with atezolizumab, carboplatin and etoposide for the treatment of previously untreated aggressive lung cancer that has spread (extensive-stage small cell lung cancer). Entinostat and etoposide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Carboplatin is a chemotherapy drug that attaches to deoxyribonucleic acid (DNA) and may kill tumor cells. Giving entinostat in combination with atezolizumab, carboplatin and etoposide may work better than atezolizumab, carboplatin and etoposide alone.
Primary Outcome
The Bayesian optimal interval (BOIN) design will be used to find the MTD based on safety as determined by dose limiting toxicities.
Conditions Studied
Interventions
- DRUG Carboplatin
- BIOLOGICAL Atezolizumab
- DRUG Etoposide
- DRUG Entinostat
Study Locations (5)
New York
- Memorial Sloan Kettering Cancer Center - New York
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Utah
- Huntsman Cancer Institute/University of Utah - Salt Lake City
Virginia
- University of Virginia Cancer Center - Charlottesville
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-04-27 |
| Est. Completion | 2023-07-11 |
| Phase | Phase 1 |
What the finished NCT04631029 record still lists
NCT04631029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT04631029 lists 5 locations in 5 states (New York, Pennsylvania, Utah).
Frequently Asked Questions
What is clinical trial NCT04631029 about?
NCT04631029 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, Entinostat, to the Usual Chemotherapy and Immunotherapy Treatment (Atezolizumab, Carboplatin and Etoposide) for Previously Untreated Aggressive Lung Cancer That Has Spread". This phase I trial seeks to find out the best dose, possible benefits and/or side effects of entinostat in combination with atezolizumab, carboplatin and etoposide for the treatment of previously untreated aggressive lung cancer that has spread (extensive-stage small cell lung cancer). Entinostat an...
What is the current status of trial NCT04631029?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2021-04-27. Estimated completion is 2023-07-11.
What conditions does trial NCT04631029 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Brain, Extensive Stage Lung Small Cell Carcinoma.
What interventions are being tested in trial NCT04631029?
The interventions under investigation include: Carboplatin (DRUG), Atezolizumab (BIOLOGICAL), Etoposide (DRUG), Entinostat (DRUG).
Who is sponsoring clinical trial NCT04631029?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04631029 being conducted?
This trial has 5 study locations across New York, Pennsylvania, Utah, Virginia, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04631029's enrollment target sits among peer trials
3 176th of 176 higher than 1 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm 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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