A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study
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
2 other identifiers
interventional
19
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 ovarian-cancer
Started Sep 2009
Typical duration for phase_2 ovarian-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2009
CompletedFirst Posted
Study publicly available on registry
August 14, 2009
CompletedStudy Start
First participant enrolled
September 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2014
CompletedResults Posted
Study results publicly available
January 7, 2015
CompletedMay 8, 2026
April 1, 2026
4.4 years
August 10, 2009
December 23, 2014
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Participants Who Experienced at Least One Adverse Event
From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days)
Incidence of Participants Who Discontinued Treatment Due to an Adverse Event
From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days)
Secondary Outcomes (1)
Incidence of All Adverse Events and Serious Adverse Events by Highest Severity Grade According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days)
Study Arms (1)
Vismodegib 150 mg
EXPERIMENTALParticipants 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.
Interventions
Vismodegib was supplied in capsules.
FOLFOX (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and oxaliplatin \[OX\]) was supplied as solutions for intravenous administration.
FOLFIRI (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and irinotecan \[IRI\]) was supplied as solutions for intravenous administration.
Bevacizumab was supplied as a solution for intravenous administration.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Intervening anti-tumor therapy not specified in the parent study (ie, non-protocol-specified chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (10)
TGen Clinical Research Srvs
Scottsdale, Arizona, 85258, United States
Children's Hospital
Oakland, California, 94609, United States
Comprehensive Cancer Care
Palm Springs, California, 92262, United States
Stanford Univ Medical Center
Stanford, California, 94305, United States
Johns Hopkins Univ Med Center
Baltimore, Maryland, 21231, United States
University Of Michigan
Ann Arbor, Michigan, 48109-0934, United States
Karmanos Cancer Institute..
Detroit, Michigan, 48201, United States
Nevada Cancer Research Foundation
Las Vegas, Nevada, 89169, United States
Irfan Firdaus, D.O.
Cincinnati, Ohio, 45242, United States
DermSurgery Associates, PA
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Genentech, Inc.
Study Officials
- STUDY DIRECTOR
Josina Reddy, MD, PhD
Genentech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2009
First Posted
August 14, 2009
Study Start
September 3, 2009
Primary Completion
January 9, 2014
Study Completion
January 9, 2014
Last Updated
May 8, 2026
Results First Posted
January 7, 2015
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing