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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
95
Progression-free Survival According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: From baseline up to disease progression or death within 30 days of last study drug administration (overall up to approximately 2.5 years)
Percentage of Participants With Objective Response According to RECIST v1.1
Time frame: From baseline up to 30 days of last study drug administration (overall up to approximately 2.5 years)
Duration of Objective Response
Time frame: From occurrence of a documented objective response until relapse or death from any cause (overall up to approximately 2.5 years)
Overall Survival (OS)
Time frame: From baseline up to death from any cause (overall up to approximately 2.5 years)
Percentage of Participants With Adverse Events (AEs)
Time frame: From baseline up to 30 days of last study drug administration (overall up to approximately 2.5 years)
Area Under the Concentration-time Curve (AUC) of DNIB0600A
Time frame: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Maximum Concentration (Cmax) of DNIB0600A
Time frame: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Clearance (CL) of DNIB0600A
Time frame: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
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St. Joseph'S Hospital & Medical Center
Phoenix, Arizona, United States
HonorHealth Research Institute - Pima Center
Scottsdale, Arizona, United States
University of California Irvine Medical Center
Orange, California, United States
Florida Cancer Specialists.
St. Petersburg, Florida, United States
Hematology & Oncology Associates
Covington, Louisiana, United States
Johns Hopkins Uni; Oncology Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Inst.
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States
...and 26 more locations
Elimination Half-life (t1/2) of DNIB0600A
Time frame: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Volume of Distribution at Steady State (Vss) of DNIB0600A
Time frame: Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4
Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against DNIB0600A
Time frame: Pre-DNIB0600A infusion on Day 1 of Cycles 1-4 (1cycle=21 days), at approximately 15-30 days after last infusion administration (overall up to approximately 2.5 years)