Overview

This trial is active, not recruiting.

Condition basal cell carcinoma
Treatment vismodegib
Phase phase 2
Target PTCH1
Sponsor Hoffmann-La Roche
Start date July 2011
End date October 2017
Trial size 1227 participants
Trial identifier NCT01367665, 2011-000195-34, MO25616

Summary

This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
vismodegib
150 mg once daily until disease progression or unacceptable toxicity

Primary Outcomes

Measure
Safety: Incidence of adverse events
time frame: Until disease progression or unacceptable toxicity (approximately 2 years)

Secondary Outcomes

Measure
Quality of life: Skindex-16 questionnaire
time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
Symptoms in metastatic BCC patients: M.D. Anderson Symptom Inventory (MDASI)
time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
Tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
Time to response
time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
Duration of response
time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
Progression-free survival
time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
Overall survival
time frame: Until disease progression or unacceptable toxicity (approximately 2 years)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/=18 years of age - Metastatic or locally advanced basal cell carcinoma considered inoperable or that surgery is contraindicated and radiotherapy is contraindicated or inappropriate - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Exclusion Criteria: - Concurrent anti-tumor therapy - Completion of the most recent anti-tumor therapy less than 21 days prior to the initiation of treatment - Uncontrolled medical illness

Additional Information

Official title A Single Arm, Open-label, Phase II, Multicentre Study, to Assess the Safety of Vismodegib (GDC-0449) in Patient With Locally Advanced or Metastatic Basal Cell Carcinoma (BCC)
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.