Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00959647
Recruitment Status : Completed
First Posted : August 14, 2009
Results First Posted : January 7, 2015
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vismodegib

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959647


Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Josina Reddy, MD, PhD Genentech, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00959647    
Other Study ID Numbers: SHH4437g
GO01352 ( Other Identifier: Hoffmann-La Roche )
First Posted: August 14, 2009    Key Record Dates
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:
Layout table for MeSH terms
Carcinoma, Basal Cell
Neoplasms
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