A Randomized Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin in Patients With Platinum-Resistant Ovarian Cancer

Status: Recruiting
Diagnosis: GYN: Ovarian, Fallopian, Peritoneal Cancer
NCT ID: NCT01991210 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-447


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.


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

Overall PI:
Joyce Liu, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Christina Herold, Beth Israel Deaconess Medical Center
Michael Birrer, MD, PhD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738, cwhalen@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

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 </= IB - Superficial myometrial invasion without vascular or lymphatic invasion - No poorly differentiated subtypes (i.e., papillary serous, clear cell, or other Federation of Gynecology and Obstetrics [FIGO] Grade 3 lesions) - Untreated or active central nervous system metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) - Pregnancy or breastfeeding - Known history of NaPi2b deficiency (e.g., congenital alveolar microlithiasis or testicular microlithiasis) - History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) - Metabolic dysfunction, physical examination finding, or clinical laboratory find gving reasonable suspicion of a disease or condition that contraindicated use of an investigational drug or may render the patient at high risk from treatment complications
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