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

Genentech, Inc.19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cancer Basal Cell Carcinoma Metastatic Colorectal Cancer

Interventions

VismodegibDRUG

Vismodegib was supplied in capsules.

FOLFOXDRUG

FOLFOX (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and oxaliplatin \[OX\]) was supplied as solutions for intravenous administration.

FOLFIRIDRUG

FOLFIRI (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and irinotecan \[IRI\]) was supplied as solutions for intravenous administration.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (10)

TGen Clinical Research Srvs

Scottsdale, Arizona, United States

Children's Hospital

Oakland, California, United States

Comprehensive Cancer Care

Palm Springs, California, United States

Outcomes

Primary Outcomes

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)

Incidence of Participants Who Discontinued Treatment Due to an 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)

Secondary Outcomes

Incidence of All Adverse Events and Serious Adverse Events by Highest Severity Grade According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0

The investigator used the adverse event (AE) grading (severity) scale found in the NCI CTCAE v3.0 to assess AE severity, with grades ranging from 1 to 5 having the following descriptions: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is very severe, life threatening or disabling, and Grade 5 is death related to AE.

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)

Data from ClinicalTrials.gov

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