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NCT03501381 · ClinicalTrials.gov registry record · Phase 2
High Dose IL 2 and Entinostat in RCC
A Phase 2 study of Renal Cell Carcinoma, sponsored by Roberto Pili.
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 5
- Study locations
NCT03501381 is a Phase 2 study of Renal Cell Carcinoma that is active but no longer recruiting, run by Roberto Pili. The registered enrollment target is 46 participants, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (81% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT03501381, a Phase 2 study of Renal Cell Carcinoma, is active but no longer recruiting, sponsored by Roberto Pili.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a multicenter, randomized, open label study of high dose interleukin 2 vs high dose interleukin 2 plus entinostat in clear cell RCC patients who are candidate for high dose interleukin 2. Patients will be randomized to ARM 1 (high dose interleukin 2 plus entinostat) or ARM 2 (high dose interleukin 2). Subjects will receive up to 3 courses of high dose interleukin 600,000 units/kg administered IV every 8 hrs on Days 1-5 and Days 15-19 (maximum 28 doses) +/- entinostat 5 mg orally given every 2 weeks starting on Day-14, continuously. Tumor response assessment will be performed between HD IL-2 courses.
Conditions Studied
Interventions
- DRUG Interleukin-2
- DRUG Entinostat
Study Locations (5)
California
- Univeristy of Southern California - Los Angeles
Illinois
- Rush University Medical Center - Chicago
Indiana
- Indiana Univeristy Melvin and Bren Simon Cancer Center - Indianapolis
Louisiana
- Hematology Oncology Clinic, LLC - Baton Rouge
Nebraska
- Nebraska Methodist Hospital - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-05-24 |
| Est. Completion | 2024-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03501381
The ClinicalTrials.gov registry entry for NCT03501381 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (81% lower). The listed sponsor is Roberto Pili, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Interleukin-2 is the first listed.
NCT03501381 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Illinois, Indiana.
Frequently Asked Questions
What is clinical trial NCT03501381 about?
NCT03501381 is a clinical study titled "High Dose IL 2 and Entinostat in RCC". This is a multicenter, randomized, open label study of high dose interleukin 2 vs high dose interleukin 2 plus entinostat in clear cell RCC patients who are candidate for high dose interleukin 2. Patients will be randomized to ARM 1 (high dose interleukin 2 plus entinostat) or ARM 2 (high dose inter...
What is the current status of trial NCT03501381?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2018-05-24. Estimated completion is 2024-04.
What conditions does trial NCT03501381 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma.
What interventions are being tested in trial NCT03501381?
The interventions under investigation include: Interleukin-2 (DRUG), Entinostat (DRUG).
Who is sponsoring clinical trial NCT03501381?
This trial is sponsored by Roberto Pili, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03501381 being conducted?
This trial has 5 study locations across California, Illinois, Indiana, Louisiana, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.