A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study
Phase 2
Completed
- Conditions
- Basal Cell CarcinomaMetastatic Colorectal CancerOvarian Cancer
- Interventions
- Registration Number
- NCT00959647
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This was a multicenter, open-label extension study. Patients who received vismodegib (GDC-0449) in a Genentech-sponsored study and who had completed the parent study or who continued to receive vismodegib at the time the parent study closed were eligible for continued treatment in this protocol.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- Completed vismodegib treatment within 2-4 weeks in a Genentech-sponsored parent study or continued to receive vismodegib at the time the Genentech-sponsored parent study closed.
- Expectation by the investigator that the participant may continue to benefit from additional vismodegib treatment.
Exclusion Criteria
- Intervening anti-tumor therapy not specified in the parent study (ie, non-protocol-specified chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vismodegib 150 mg FOLFOX Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator. Vismodegib 150 mg FOLFIRI Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator. Vismodegib 150 mg Bevacizumab Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator. Vismodegib 150 mg Vismodegib Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Experienced at Least 1 Adverse Event Baseline until 30 days following the last administration of study treatment Percentage of Participants Who Discontinued Treatment Due to an Adverse Event Baseline until 30 days following the last administration of study treatment
- Secondary Outcome Measures
Name Time Method Incidence and Severity of All Adverse Events and Serious Adverse Events 30 days following the last administration of study treatment Incidence of Adverse Events Leading to GDC-0449 Discontinuation 30 days following the last administration of study treatment