A randomized study of the safety and efficacy of a novel drug, DNIB0600A, compared to chemotherapy when given intravenously to patients with ovarian cancer.
- Conditions
- Platinum Resistant Ovarian CancerMedDRA version: 17.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-005776-34-BE
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 92
• Signed informed consent form
• Age = 18 years
• Life expectancy of at least 12 weeks
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Histological documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding carcinosarcoma histology)
• Availability and willingness to provide an adequate archival sample of tumor (paraffin tissue block or at least 15 unstained slides); if an archival tissue specimen is not available and a new tissue specimen is collected for diagnostic purposes for patient care, then fresh tissue may be submitted
• 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 pegylated liposomal doxorubicin (PLD) is appropriate
• Measurable disease with at least one lesion that can be accurately measured in at least one dimension (longest dimension recorded = 2.0 cm using conventional techniques or = 1.0 cm on spiral computed tomography [CT] scan) per RECIST v1.1 criteria
• No more than one prior cytotoxic chemotherapy regimen for the treatment of PROC and no more than two total regimens (defined as any therapy [approved or investigational] with intent to treat the ovarian cancer)
• Absolute neutrophil count = 1500/µL, hemoglobin = 9 g/dL, and platelet count = 100,000/µL
• Total bilirubin = 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 ×ULN
• Serum creatinine = 2.0 mg/dL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 92
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 pegylated liposomal doxorubicin (PLD) (e.g., Doxil, Caelyx,• 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 (LVEF) defined by MUGA/ECHO below the institutional lower limit of normal (LLN)
• Evidence of significant, uncontrolled, concomitant disease which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease, history of bronchospasm, or any ongoing requirement for supplemental oxygen)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method