A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL EVALUATING THE EFFICACY AND SAFETY OF GDC-0449 AS MAINTENANCE THERAPY IN PATIENTS WITH OVARIAN CANCER IN A SECOND OR THIRD COMPLETE REMISSION.

• Conditions: OVARIAN CANCER (SECOND OR THIRD COMPLETE REMISSION); MedDRA version: 9.1Level: LLTClassification code 10066697Term: Ovarian cancer recurrent

• Registration Number: EUCTR2008-003789-24-BE
• Lead Sponsor: Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 100

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.
The study investigator should confirm the status of disease remission by CT scan
before patient enrollment.
If patient has lymphadenopathy by CT scan and the investigator thinks that it is
unlikely due to ovarian cancer, this patient is considered eligible. If indicated,
a confirmatory biopsy should be performed.
• Patients must have completed their most recent dose of cytotoxic
chemotherapy regimen (platinum-based or non-platinum based) no less than
3 weeks and no more than 14 weeks prior to randomization.
• 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. Archival
tissues are to be sent as soon as possible.
• 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 calculated creatinine clearance > 50 mL/minute
• Negative serum or urine 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 acceptable
and 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

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 acceptable
and 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). Hormonal replacement therapies for
treatment of postmenopausal symptoms do not exclude patients from this study.
• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified