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NCT01846611 · ClinicalTrials.gov registry record · Phase 3

A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 3 study of Ovarian Neoplasms and Peritoneal Neoplasms, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 3
Development phase
581
Enrollment target
20
Study locations

NCT01846611 is a Phase 3 study of Ovarian Neoplasms and Peritoneal Neoplasms that has completed, run by Janssen Research & Development. The registered enrollment target is 581 participants, above the 353-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (65% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT01846611, a Phase 3 study of Ovarian Neoplasms and Peritoneal Neoplasms, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 3
Development phase
581 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy.

Conditions Studied

Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms

Interventions

  • DRUG Dexamethasone
  • DRUG Trabectedin
  • DRUG DOXIL

Study Locations (20)

California

  • - Greenbrae
  • - La Jolla
  • - Los Angeles
  • - Orange
  • - Sacramento

Florida

  • - Fort Myers
  • - Jacksonville
  • - Miami
  • - Sarasota
  • - St. Petersburg

Arizona

  • - Phoenix
  • - Scottsdale
  • - Sedona
  • - Tucson

Connecticut

  • - New Britain
  • - New Haven
  • - Stamford

Alabama

  • - Birmingham

Arkansas

  • - Hot Springs

Colorado

  • - Englewood

Trial Details

FieldValue
Enrollment Target 581 participants
Start Date 2013-10-16
Est. Completion 2018-11-16
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01846611

The ClinicalTrials.gov registry entry for NCT01846611 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 581 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 353-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (65% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Ovarian Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone is the first listed.

NCT01846611 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT01846611 about?

NCT01846611 is a clinical study titled "A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer". The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based ...

What is the current status of trial NCT01846611?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 581 participants. The study started on 2013-10-16. Estimated completion is 2018-11-16.

What conditions does trial NCT01846611 study?

This clinical trial studies the following conditions: Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms.

What interventions are being tested in trial NCT01846611?

The interventions under investigation include: Dexamethasone (DRUG), Trabectedin (DRUG), DOXIL (DRUG).

Who is sponsoring clinical trial NCT01846611?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01846611 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.