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

Genentech

Status and phase: Completed; Phase 2

Conditions: Metastatic Colorectal Cancer; Ovarian Cancer; Basal Cell Carcinoma

Treatments: Drug: Bevacizumab; Drug: FOLFIRI; Drug: FOLFOX; Drug: Vismodegib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00959647

SHH4437g

GO01352 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Vismodegib 150 mg

Experimental group

Description:

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.

Treatment:

Drug: Vismodegib

Drug: Bevacizumab

Drug: FOLFOX

Drug: FOLFIRI