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NCT01524991 · ClinicalTrials.gov registry record · Phase 2

First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma

A Phase 2 study of Urothelial Carcinoma, sponsored by Hoosier Cancer Research Network.

Completed
Registry status
Phase 2
Development phase
36
Enrollment target
8
Study locations

NCT01524991 is a Phase 2 study of Urothelial Carcinoma that has completed, run by Hoosier Cancer Research Network. The registered enrollment target is 36 participants, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (85% lower). The trial reports 8 study locations across 6 states.

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The verdict

NCT01524991, a Phase 2 study of Urothelial Carcinoma, has completed, sponsored by Hoosier Cancer Research Network.

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target
8
Study locations

Study Summary

Gemcitabine plus cisplatin is standard treatment for advanced urothelial cancer. Ipilimumab has shown intriguing activity as neoadjuvant therapy in patients with clinically localized bladder cancer undergoing radical cystectomy. The combination of gemcitabine, cisplatin, plus ipilimumab may build on the chemosensitivity of urothelial carcinoma to produce more durable responses and improved outcomes.

Conditions Studied

Interventions

  • DRUG Cisplatin
  • DRUG Ipilimumab
  • DRUG Gemcitabine

Study Locations (8)

Indiana

  • IU Health Goshen Hospital - Goshen
  • Indiana University Melvin & Bren Simon Cancer Center - Indianapolis
  • IU Health Central Indiana Cancer Centers - Indianapolis

California

  • City of Hope: Duarte - Duarte

Nebraska

  • Nebraska Cancer Specialists - Omaha

New York

  • Tisch Cancer Institute at Mount Sinai Medical Center - New York

Texas

  • Texas Oncology, PA - Dallas

Virginia

  • Virginia Oncology Associates - Norfolk

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2012-01
Est. Completion 2018-12-31
Phase Phase 2

Sponsor

Hoosier Cancer Research Network

26 total trials

What the Registry Record Tells You About NCT01524991

The ClinicalTrials.gov registry entry for NCT01524991 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (85% lower). The listed sponsor is Hoosier Cancer Research Network, which has 26 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.

NCT01524991 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Indiana, California, Nebraska.

Frequently Asked Questions

What is clinical trial NCT01524991 about?

NCT01524991 is a clinical study titled "First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma". Gemcitabine plus cisplatin is standard treatment for advanced urothelial cancer. Ipilimumab has shown intriguing activity as neoadjuvant therapy in patients with clinically localized bladder cancer undergoing radical cystectomy. The combination of gemcitabine, cisplatin, plus ipilimumab may build on...

What is the current status of trial NCT01524991?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2012-01. Estimated completion is 2018-12-31.

What conditions does trial NCT01524991 study?

This clinical trial studies the following conditions: Urothelial Carcinoma.

What interventions are being tested in trial NCT01524991?

The interventions under investigation include: Cisplatin (DRUG), Ipilimumab (DRUG), Gemcitabine (DRUG).

Who is sponsoring clinical trial NCT01524991?

This trial is sponsored by Hoosier Cancer Research Network, which has 26 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01524991 being conducted?

This trial has 8 study locations across California, Indiana, Nebraska, New York, Texas. 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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