Overview

This trial is active, not recruiting.

Condition ovarian cancer, epithelial tumors, malignant, fallopian tube cancer, peritoneal neoplasms
Treatments dnib0600a, pegylated liposomal doxorubicin
Phase phase 2
Sponsor Genentech, Inc.
Start date February 2014
End date January 2016
Trial size 95 participants
Trial identifier NCT01991210, 2012-005776-34, GO28609

Summary

This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A in comparison with pegylated liposomal doxorubicin (PLD) in patients with platinum-resistant ovarian cancer, primary peritoneal cancer or fallopian tube cancer. Patients will be randomized to receive either DNIB0600A 2.4 mg/kg intravenously every three weeks or PLD 40 mg/m2 intravenously every four weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
dnib0600a
2.4 mg/kg IV every three weeks
(Active Comparator)
pegylated liposomal doxorubicin
40 mg/m2 IV every four weeks

Primary Outcomes

Measure
Progression-free survival
time frame: up to approximately 2.5 years

Secondary Outcomes

Measure
Objective response (complete response or partial response)
time frame: up to approximately 2.5 years
Duration of objective response
time frame: up to approximately 2.5 years
Overall survival
time frame: up to approximately 2.5 years
Safety: Incidence of adverse events
time frame: up to approximately 2.5 years
Pharmacokinetics: Area under the concentration-time curve (AUC)
time frame: Cycles 1-4, up to approximately 2.5 years
Incidence of anti-therapeutic antibodies (ATAs)
time frame: Day 1 every cycle, up to approximately 2.5 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer - Advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 6 months after the most recent treatment with a platinum-containing chemotherapy regimen and for whom PLD is appropriate therapy - No more than one prior chemotherapy regimens for the treatment of PROC (chemotherapy is defined as any cytotoxic, biologic, or targeted therapy [approved or investigational] with intent to treat the ovarian cancer) - Adequate hematologic, renal and liver function - Willing and able to perform a PRO survey (including the possibility of using an electronic PRO device) - For women of childbearing potential, agreement to use one highly effective form of contraception as defined by protocol through the course of study treatment and for 3 months after the last dose of study treatment Exclusion Criteria: - Primary platinum-refractory disease defined as disease progression during or within 2 months of a first-line, platinum-containing chemotherapy regimen - Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, within 4 weeks prior to Day 1 - Palliative radiation within 2 weeks prior to Day 1 - Prior anthracycline therapy, including prior treatment with PLD (e.g., Doxil®, Caelyx®, or Lipodox®) in any setting (e.g., in combination with carboplatin or as a single agent) - Prior treatment with NaPi2b or SCL34A2 targeted therapy - Major surgical procedure within 4 weeks prior to Day 1 - Current Grade > 1 toxicity (except alopecia and anorexia) from prior therapy or Grade >1 neuropathy from any cause - Left ventricular ejection fraction defined by MUGA/echocardiogram below the institutional lower limit of normal - Evidence of significant, uncontrolled, concomitant disease that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or significant pulmonary disease - Known active infection, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (within 4 weeks prior to Cycle 1, Day 1 - Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis - Presence of positive test results for hepatitis B or hepatitis C as detailed in the protocol - Known history of HIV seropositive status - Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix, squamous carcinoma of the skin, adequately controlled limited basal cell skin cancer, or synchronous primary endometrial cancer or prior primary endometrial cancer if all of the following criteria are met: - Stage

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Genentech, Inc..