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

NCT ID: NCT00959647

Last Updated: 2015-01-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-01-31

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.

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Detailed Description

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Conditions

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Ovarian Cancer Basal Cell Carcinoma Metastatic Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vismodegib 150 mg

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.

Group Type EXPERIMENTAL

Vismodegib

Intervention Type DRUG

Vismodegib was supplied in capsules.

FOLFOX

Intervention Type DRUG

FOLFOX (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and oxaliplatin \[OX\]) was supplied as solutions for intravenous administration.

FOLFIRI

Intervention Type DRUG

FOLFIRI (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and irinotecan \[IRI\]) was supplied as solutions for intravenous administration.

Bevacizumab

Intervention Type DRUG

Bevacizumab was supplied as a solution for intravenous administration.

Interventions

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Vismodegib

Vismodegib was supplied in capsules.

Intervention Type DRUG

FOLFOX

FOLFOX (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and oxaliplatin \[OX\]) was supplied as solutions for intravenous administration.

Intervention Type DRUG

FOLFIRI

FOLFIRI (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and irinotecan \[IRI\]) was supplied as solutions for intravenous administration.

Intervention Type DRUG

Bevacizumab

Bevacizumab was supplied as a solution for intravenous administration.

Intervention Type DRUG

Other Intervention Names

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Erivedge GDC-0449 RO5450815 Avastin

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josina Reddy, MD, PhD

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Scottsdale, Arizona, United States

Site Status

Oakland, California, United States

Site Status

Palm Springs, California, United States

Site Status

Stanford, California, United States

Site Status

Baltimore, Maryland, United States

Site Status

Ann Arbor, Michigan, United States

Site Status

Detroit, Michigan, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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GO01352

Identifier Type: OTHER

Identifier Source: secondary_id

SHH4437g

Identifier Type: -

Identifier Source: org_study_id

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