Back to resultsA Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study
Primary Purpose
Ovarian Cancer, Basal Cell Carcinoma, Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vismodegib
FOLFOX
FOLFIRI
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Hedgehog pathway inhibitor
Eligibility 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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vismodegib 150 mg
Arm 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.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Experienced at Least 1 Adverse Event
Percentage of Participants Who Discontinued Treatment Due to an Adverse Event
Secondary Outcome Measures
Incidence and Severity of All Adverse Events and Serious Adverse Events
Incidence of Adverse Events Leading to GDC-0449 Discontinuation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00959647
Brief Title
A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study
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 Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Basal Cell Carcinoma, Metastatic Colorectal Cancer
Keywords
Hedgehog pathway inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vismodegib 150 mg
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Vismodegib
Other Intervention Name(s)
Erivedge, GDC-0449, RO5450815
Intervention Description
Vismodegib was supplied in capsules.
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Intervention Description
FOLFOX (folinic acid [FOL, leucovorin], fluorouracil [F, 5-FU], and oxaliplatin [OX]) was supplied as solutions for intravenous administration.
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
FOLFIRI (folinic acid [FOL, leucovorin], fluorouracil [F, 5-FU], and irinotecan [IRI]) was supplied as solutions for intravenous administration.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab was supplied as a solution for intravenous administration.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced at Least 1 Adverse Event
Time Frame
Baseline until 30 days following the last administration of study treatment
Title
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 Measure Information:
Title
Incidence and Severity of All Adverse Events and Serious Adverse Events
Time Frame
30 days following the last administration of study treatment
Title
Incidence of Adverse Events Leading to GDC-0449 Discontinuation
Time Frame
30 days following the last administration of study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josina Reddy, MD, PhD
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0934
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study
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