OVARIAN CANCER (SECOND OR THIRD COMPLETE REMISSION) MedDRA version: 9.1 Level: LLT Classification code 10066697 Term: Ovarian cancer recurrent
Conditions
Interventions
Product Name: GDC-0449
Product Code: GDC-0449
Pharmaceutical Form: Capsule*
Current Sponsor code: GDC-0449
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Phar
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following inclusion criteria to be eligible for study entry: • Age = 18 years • Histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma • Must be in second or third complete remission, have received chemotherapy (platinum-based and/or non-platinum-based) for recurrent disease, and have achieved a complete remission after their most recent chemotherapy regimen Complete remission is defined as no symptoms suggestive of persistent cancer, CT scan of the chest/abdomen/pelvis without evidence of ovarian cancer within 4 weeks of randomization, and normal CA-125 (measured within 2 weeks of randomization) following completion of prior chemotherapy. • Patients must have completed their most recent cytotoxic chemotherapy regimen (platinum-based or non-platinum based) no less than 3 weeks and no more than 12 weeks prior to screening. • Archival tissue must be available and requested. The tissue must consist of representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, obtained at any time prior to entry of study. • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (see Appendix D) • Adequate hematopoietic capacity, as defined by the following: Hemoglobin > 8.5 g/dL, not transfusion-dependent Granulocyte count = 1200/µL Platelets = 75,000/µL • Adequate hepatic function, as defined by the following: AST and ALT = 3 × the upper limit of normal (ULN) Total bilirubin = 1.5 × ULN or within 3 × ULN for patients with Gilbert’s disease • Adequate renal function, as defined by the following: Serum creatinine = 2.0 mg/dL or measured creatinine clearance > 50 mL/minute • Negative pregnancy test on Day 1 • For women of childbearing potential: Use of two effective methods of barrier contraception, including one barrier method (See Appendix C for unacceptable methods of contraception.) • Signed informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: • Pregnancy or lactation For women of childbearing potential: use of two effective methods of barrier contraception, including one barrier method, during the study and for 12 months after discontinuing study drug (see Appendix C for unacceptable methods of contraception). • Patients whose ovarian cancer is in first remission • Patients must not have experienced more than two prior recurrences of disease • Concurrent non-protocol-specified anti-tumor therapy, either approved or unapproved (e.g., chemotherapy, hormonal therapy, other targeted therapy, radiation therapy, surgery, herbal therapy) • Current, recent (within 4 weeks of Day 1), or planned participation in an experimental drug study while enrolled in this study • History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated BCC or squamous-cell carcinoma of the skin; ductal carcinoma in situ of the breast; or carcinoma in situ of the cervix • Uncontrolled medical illnesses such as infection requiring IV antibiotics • Life expectancy < 12 weeks • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for this study is as follows: • To estimate the clinical benefit of the addition of GDC-0449 as maintenance therapy for patients with ovarian cancer in a second or third complete remission, as measured by investigator-determined PFS by radiographic assessment;Secondary Objective: Secondary objectives for this study are as follows: • To make a preliminary assessment of the safety and tolerability of GDC-0449 in this population • To evaluate the relationship between detectable Hh expression in archival tumor tissue and clinical benefit of GDC-0449 in patients as measured by PFS • To make a preliminary assessment of the efficacy of GDC-0449 as measured by overall survival Exploratory objectives for this study are as follows: • To explore the effect of Hh expression in archival tumor tissue on secondary endpoints • To explore the effect of Hh pathway signaling on primary and secondary endpoints • To explore the effect of GDC-0449 on PFS as assessed by a combination of CA-125 and radiographic criteria;Primary end point(s): The primary efficacy endpoint in this study is the hazard ratio (HR) of PFS using the stratified Cox model. PFS will be defined as the time from randomization until the first occurrence of radiographic progression or death from any cause, determined by the investigator (see Primary Efficacy Outcome Measures, Section 3.3.1, for a definition of radiographic progression). Patients who do not meet the criteria for disease progression, but who die, will be treated as having progressed for the PFS analysis. Patients who do not meet the criteria for disease progression and who do not die will be censored at the time of last tumor assessment. | — |
Countries
Belgium, Spain, United Kingdom
Outcome results
None listed