A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remissio

Not Applicable

• Conditions: -C56 Malignant neoplasm of ovary; Malignant neoplasm of ovary; C56

• Registration Number: PER-133-08
• Lead Sponsor: GENENTECH, INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-13
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 0

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 <3x the upper limit of normal (ULN), Total bilirubin <1.5x ULN or within 3x ULN for patients with Gilbert´s disease
• Adequate renal function, 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 with pregnancy potential: Use of two effective barrier contraception methods, including a barrier method
• Signed informed consent

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified