Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 42 of 78 for:    vismodegib

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.

Tracking Information
First Submitted Date  ICMJE August 10, 2009
First Posted Date  ICMJE August 14, 2009
Results First Submitted Date  ICMJE December 23, 2014
Results First Posted Date  ICMJE January 7, 2015
Last Update Posted Date January 7, 2015
Study Start Date  ICMJE September 2009
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2009)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Cancer
  • Basal Cell Carcinoma
  • Metastatic Colorectal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Vismodegib
  • Drug: FOLFOX
  • Drug: FOLFIRI
  • Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 29, 2012)
19
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2009)
250
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00959647
Other Study ID Numbers  ICMJE SHH4437g
GO01352 ( Other Identifier: Hoffmann-La Roche )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Josina Reddy, MD, PhD Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP