A Study to Evaluate the Safety and Pharmacology of DNIB0600A in Patients With Ovarian Cancer

Status: Recruiting
Phase:
Diagnosis: GYN: Ovarian, Fallopian, Peritoneal Cancer
NCT ID: NCT01995188 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-483

 

This open-label, multicenter, phase 1b study will evaluate the safety and pharmacokinetics of DNIB0600A in patients with platinum-sensitive ovarian cancer. The maximum tolerated dose of intravenously infused DNIB0600A in combination with carboplatin will be determined in escalating dose cohorts. The combination of DNIB0600A and carboplatin will then be evaluated with and without bevacizumab [Avastin] in two dose expansion cohorts.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

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

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Christin Whalen, cwhalen@partners.org

Eligibility Criteria

Inclusion Criteria: - Age >/= 18 years. - Eastern Cooperative Oncology Group (ECOG) status of 0 or 1. - Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is platinum sensitive. - Platinum-sensitive ovarian cancer with documented radiographic progression or relapse within 6 to 18 months of most recent platinum-based chemotherapy. - Available tumor specimen. - Measurable disease. - Female patients of childbearing potential must use effective contraception as defined by study protocol and cannot be pregnant or breastfeeding. Exclusion Criteria: - Anti-tumor therapy of any kind or major surgery within 4 weeks prior to Day 1. - Platinum-based chemotherapy within 6 months prior to Day 1. - Palliative radiation within 2 weeks prior to Day 1. - Toxicity (except alopecia and anorexia) from prior therapy or neuropathy of grades > 1. - Evidence of any significant disease or condition that could affect compliance with the protocol or interpretation of results. - Known active infection (except fungal nail infections). - History of liver disease or HIV. - Other malignancy within the last 5 years, except for adequately treated or controlled carcinoma in situ of the cervix or skin cancer or primary endometrial cancer of stage </= 1B. - Untreated or active CNS metastases. - Prior treatment with NaPi2b- targeted therapy. Bevacizumab [Avastin]-Specific Exclusion Criteria: - Inadequately controlled hypertension or history of hypertensive crisis or encephalopathy. - History of heart problems or thrombosis within 6 months prior to study start. - History of stroke within 6 months prior to study enrollment. - History of significant vascular disease. - History of expectoration of blood within 1 month prior to study start or blood clotting problems. - Core biopsy or other minor surgical procedure within 7 days prior to study start - Serious and non-healing wound, active ulcer, or untreated bone fracture.
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