None listed
Conditions
Interventions
Group 1 Type of group
Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Group name:Group 2 Type of group
Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
Sponsors
GENENTECH, INC.,
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age> 18 years • Histological diagnoses of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma • They must be in second or third complete remission, have received chemotherapy (platinum-based and / or non-platinum-based) for recurrent disease, and have achieved full remission after the most recent chemotherapy regimen • Patients must have completed their most recent cytotoxic chemotherapy regimens (platinum-based and / or non-platinum-based) no less than 3 weeks and no more than 12 weeks before screening. • Preserved tissue should be available and requested. • Performance status O or 1 by the Eastern Cooperative Oncology Group (ECOG) • Adequate hematopoietic capacity, defined as follows: Hemoglobin> 8.5 g / dL, non-transfusion dependent, Granulocyte count> 1200 / uL, Platelets> 75,000 / uL • Adequate liver function, defined as follows: AST and ALT 50 mL / minute • Negative pregnancy test on Day 1 • For women with pregnancy potential: Use of two effective barrier contraception methods, including a barrier method • Signed informed consent
Exclusion criteria
Exclusion criteria: • Pregnancy or breastfeeding. For women with pregnancy potential: Use of two effective methods of barrier contraception, including a barrier method, during the study and for 12 months after discontinuation of the drug under study (see Annex 0 for unacceptable contraception methods). • Patients whose ovarian cancer is in first remission • Patients should not have experienced more than two previous disease recurrences • Anti-tumor therapy not specified by concurrent protocol, whether approved or not approved (for example, chemotherapy, hormonal therapy, other specified therapy, radiotherapy, 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 an insignificant risk for metastases or death, such as properly treated BBC or squamous cell carcinoma of the skin; ductal carcinoma in situ of the breast; or carcinoma in situ of the cervix • Uncontrolled drug disease such as infections that require IV antibiotics • Life expectancy <12 weeks • History of another disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that indicates reasonable suspicion of a disease or condition that contraindicates the use of a drug under investigation or that may affect the interpretation of study results or put to the patient at high risk of treatment complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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. Measure:Progression-free Survival (PFS) Timepoints:From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Hedgehog antigen expression was measured with immunohistochemical methods in tumor tissue taken from each patient prior to enrollment in the study. The percentage of cells with (> 0%) and without (0%) Hedgehog antigen expression was measured microscopically. PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study. Measure:Progression-free Survival (PFS) in Patients With Versus Without Hedgehog Antigen Tumor Expression Timepoints:From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks ; Outcome name:Overall survival was defined as the time from randomization until death by any cause. Measure:Overall Survival Timepoints:From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks | — |
Countries
Belgium, Brazil, Israel, Peru, Poland, Russian Federation, Spain, United Kindgdom, United States
Contacts
Public ContactLUIS MIGUEL MELENDEZ
PPD Peru S.A.C.
Outcome results
None listed