A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Vismodegib 150 mg; Placebo to vismodegib
Intervention description: Vismodegib 150 mg was provided in hard gelatin capsules.; Placebo to vismodegib consisted of the excipients for vismodegib without the active molecule in hard gelatin capsules matching the active drug product in color and size.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 104.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Systemic Hedgehog; Hedgehog Pathway Inhibitor

Summary:

      The study was a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical
      trial of vismodegib (GDC-0449) in patients with ovarian cancer in a second or third complete
      remission. Patients were randomized in a 1:1 ratio to either vismodegib or placebo.
      Randomization was stratified based on whether their cancer was in a second or third complete
      remission.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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, computed tomography (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 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.

          -  Negative pregnancy test on Day 1 (first day the patient receives vismodegib or
             placebo).

          -  For women of childbearing potential: Use of two effective methods of contraception,
             including one barrier method.

        Exclusion Criteria:

          -  Pregnancy or lactation.

          -  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
             (eg, 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 basal cell
             carcinoma (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 intravenous (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.