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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959647
• Other study ID #: SHH4437g
• Secondary ID: GO01352
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2009
• Last updated: December 23, 2014
• Start date: September 2009
• Est. completion date: January 2014

Study information

• Verified date: December 2014
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma, Basal Cell
• Metastatic Colorectal Cancer
• Ovarian Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Experienced at Least 1 Adverse Event		Baseline until 30 days following the last administration of study treatment	No
Primary	Percentage of Participants Who Discontinued Treatment Due to an Adverse Event		Baseline until 30 days following the last administration of study treatment	No
Secondary	Incidence and Severity of All Adverse Events and Serious Adverse Events		30 days following the last administration of study treatment	No
Secondary	Incidence of Adverse Events Leading to GDC-0449 Discontinuation		30 days following the last administration of study treatment	No