Trials / Terminated
TerminatedNCT01991210
A Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin (PLD) in Participants With Platinum-Resistant Ovarian Cancer (PROC)
A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of DNIB0600A Compared to Pegylated Liposomal Doxorubicin Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2014-02-06
- Primary completion
- 2016-08-17
- Completion
- 2016-08-17
- First posted
- 2013-11-25
- Last updated
- 2017-08-21
Locations
36 sites across 7 countries: United States, Belgium, Canada, France, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01991210. Inclusion in this directory is not an endorsement.