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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.

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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

FieldValue
Enrollment Target 46 participants
Start Date 2018-05-24
Est. Completion 2024-04
Phase Phase 2

Sponsor

Roberto Pili

3 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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