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Completed

NCT Number: NCT00959647

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Metastatic Colorectal Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Rectal Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

TGen Clinical Research Srvs, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

vismodegib

Drug

Vismodegib was supplied in capsules.

Other names: Erivedge, GDC-0449, RO5450815

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.

Other names: Avastin

Primary outcomes

  1. 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)

  2. 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

  1. 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

    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)

    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.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Aug 14, 2009
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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