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A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission

Phase 2
18 Years
Not Enrolling
Ovarian Cancer

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Trial Information

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission

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

- 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)

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Since patients were in remission at the start of the study, they had no evidence of the presence of tumors. Disease progression was defined as radiographic evidence of a tumor. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.

Outcome Time Frame:

From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks

Safety Issue:


Principal Investigator

Josina Reddy, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

November 2010

Related Keywords:

  • Ovarian Cancer
  • Systemic Hedgehog
  • Hedgehog Pathway Inhibitor
  • Ovarian Neoplasms