A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Multicenter Extension Study of GDC-0449 (Hedgehog Pathway Inhibitor) in Patients Treated With GDC-0449 in a Previous Genentech-sponsored Phase I or Phase II Cancer Study

Conditions
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Ovarian Cancer, Basal Cell Carcinoma, Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Vismodegib
* Drug: FOLFOX
* Drug: FOLFIRI
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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This study only enrolled participants who took part in previous studies of vismodegib conducted by Genentech. 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vismodegib 150 mg<br>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. | Drug: Vismodegib<br>* Vismodegib was supplied in capsules.<br>* Other names: RO5450815;Drug: FOLFOX<br>* FOLFOX (folinic acid [FOL, leucovorin], fluorouracil [F, 5-FU], and oxaliplatin [OX]) was supplied as solutions for intravenous administration.<br>Drug: FOLFIRI<br>* FOLFIRI (folinic acid [FOL, leucovorin], fluorouracil [F, 5-FU], and irinotecan [IRI]) was supplied as solutions for intravenous administration.<br>Drug: Bevacizumab<br>* Bevacizumab was supplied as a solution for intravenous administration.<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hedgehog pathway inhibitor