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

• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer; Basal Cell Carcinoma; Metastatic Colorectal Cancer	Drug: Vismodegib; Drug: FOLFOX; Drug: FOLFIRI; Drug: Bevacizumab	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 19 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: September 2009
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

Drug: Vismodegib; Vismodegib was supplied in capsules.; Other Names: Erivedge; GDC-0449; RO5450815; Drug: FOLFOX; FOLFOX (folinic acid [FOL, leucovorin], fluorouracil [F, 5-FU], and oxaliplatin [OX]) was supplied as solutions for intravenous administration.; Drug: FOLFIRI; FOLFIRI (folinic acid [FOL, leucovorin], fluorouracil [F, 5-FU], and irinotecan [IRI]) was supplied as solutions for intravenous administration.; Drug: Bevacizumab; Bevacizumab was supplied as a solution for intravenous administration.; Other Name: Avastin

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Who Experienced at Least 1 Adverse Event [ Time Frame: Baseline until 30 days following the last administration of study treatment ]
2. Percentage of Participants Who Discontinued Treatment Due to an Adverse Event [ Time Frame: Baseline until 30 days following the last administration of study treatment ]

Secondary Outcome Measures :

1. Incidence and Severity of All Adverse Events and Serious Adverse Events [ Time Frame: 30 days following the last administration of study treatment ]
2. Incidence of Adverse Events Leading to GDC-0449 Discontinuation [ Time Frame: 30 days following the last administration of study treatment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

United States, Arizona

Scottsdale, Arizona, United States, 85258

United States, California

Oakland, California, United States, 94609

Palm Springs, California, United States, 92262

Stanford, California, United States, 94305

United States, Maryland

Baltimore, Maryland, United States, 21231

United States, Michigan

Ann Arbor, Michigan, United States, 48109-0934

Detroit, Michigan, United States, 48201

United States, Nevada

Las Vegas, Nevada, United States, 89106

United States, Ohio

Cincinnati, Ohio, United States, 45242

United States, Texas

Houston, Texas, United States, 77030

Sponsors and Collaborators

Genentech, Inc.

Investigators

• Study Director: Josina Reddy, MD, PhD; Genentech, Inc.

More Information

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT00959647 History of Changes
• Other Study ID Numbers: SHH4437g; GO01352 ( Other Identifier: Hoffmann-La Roche )
• First Posted: August 14, 2009
• Results First Posted: January 7, 2015
• Last Update Posted: January 7, 2015
• Last Verified: December 2014

Keywords provided by Genentech, Inc.:

Hedgehog pathway inhibitor

Additional relevant MeSH terms:

Colorectal Neoplasms; Carcinoma, Basal Cell; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Bevacizumab; Antineoplastic Agents, Immunological; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors