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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Genentech, Inc.
Study ID
NCT00959647
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vismodegib — DRUG
    Vismodegib was supplied in capsules.
  • FOLFOX — DRUG
    FOLFOX (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and oxaliplatin \[OX\]) was supplied as solutions for intravenous administration.
  • FOLFIRI — DRUG
    FOLFIRI (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and irinotecan \[IRI\]) was supplied as solutions for intravenous administration.
  • Bevacizumab — DRUG
    Bevacizumab was supplied as a solution for intravenous administration.

Study Details

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.

Key Dates

First listed
Aug 14, 2009
Start date
Sep 3, 2009
Status verified
Apr 2026
Primary completion
Jan 9, 2014
Completion
Jan 9, 2014

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Incidence of Participants Who Experienced at Least One Adverse Event [ Time Frame: 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) ]

Locations (10)

FacilityCityStateZIPSite coordinators
TGen Clinical Research SrvsScottsdaleArizona85258-
Children's HospitalOaklandCalifornia94609-
Comprehensive Cancer CarePalm SpringsCalifornia92262-
Stanford Univ Medical CenterStanfordCalifornia94305-
Johns Hopkins Univ Med CenterBaltimoreMaryland21231-
University Of MichiganAnn ArborMichigan48109-0934-
Karmanos Cancer Institute..DetroitMichigan48201-
Nevada Cancer Research FoundationLas VegasNevada89169-
Irfan Firdaus, D.O.CincinnatiOhio45242-
DermSurgery Associates, PAHoustonTexas77030-

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TGen Clinical Research Srvs· Scottsdale, AZChildren's Hospital· Oakland, CAComprehensive Cancer Care· Palm Springs, CAStanford Univ Medical Center· Stanford, CAJohns Hopkins Univ Med Center· Baltimore, MDUniversity Of Michigan· Ann Arbor, MI

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