MedTrace Logo

A Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin (PLD) in Participants With Platinum-Resistant Ovarian Cancer (PROC)

NCT01991210 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2017-08-21

No results posted yet for this study

Summary

This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A (RO5541081) in comparison with PLD in participants with PROC, primary peritoneal cancer or fallopian tube cancer. Participants will be randomized to receive either DNIB0600A 2.4 milligrams per kilogram (mg/kg) intravenously (IV) every 3 weeks or PLD 40 milligrams per meter-squared (mg/m\^2) IV every 4 weeks.

Conditions

Interventions

DRUG

DNIB0600A

DNIB0600A will be administered at a dose of 2.4 mg/kg IV every 3 weeks.

DRUG

PLD

PLD will be administered at a dose of 40 mg/m\^2 IV every 4 weeks.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-06
Primary Completion
2016-08-17
Completion
2016-08-17

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01991210 on ClinicalTrials.gov