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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00959647
First received: August 10, 2009
Last updated: December 23, 2014
Last verified: December 2014
  Purpose

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 Intervention Phase
Ovarian Cancer
Basal Cell Carcinoma
Metastatic Colorectal Cancer
Drug: Vismodegib
Drug: FOLFOX
Drug: FOLFIRI
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants Who Experienced at Least 1 Adverse Event [ Time Frame: Baseline until 30 days following the last administration of study treatment ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Discontinued Treatment Due to an Adverse Event [ Time Frame: Baseline until 30 days following the last administration of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and Severity of All Adverse Events and Serious Adverse Events [ Time Frame: 30 days following the last administration of study treatment ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events Leading to GDC-0449 Discontinuation [ Time Frame: 30 days following the last administration of study treatment ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: September 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959647

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

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00959647     History of Changes
Other Study ID Numbers: SHH4437g, GO01352
Study First Received: August 10, 2009
Results First Received: December 23, 2014
Last Updated: December 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
Hedgehog pathway inhibitor

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015