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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|ClinicalTrials.gov Identifier: NCT00959647|
Recruitment Status : Completed
First Posted : August 14, 2009
Results First Posted : January 7, 2015
Last Update Posted : January 7, 2015
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
Other Name: Avastin
- Percentage of Participants Who Experienced at Least 1 Adverse Event [ Time Frame: Baseline until 30 days following the last administration of study treatment ]
- Percentage of Participants Who Discontinued Treatment Due to an Adverse Event [ Time Frame: Baseline until 30 days following the last administration of study treatment ]
- Incidence and Severity of All Adverse Events and Serious Adverse Events [ Time Frame: 30 days following the last administration of study treatment ]
- Incidence of Adverse Events Leading to GDC-0449 Discontinuation [ Time Frame: 30 days following the last administration of study treatment ]
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
|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|
|Study Director:||Josina Reddy, MD, PhD||Genentech, Inc.|