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STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01367665
First received: May 30, 2011
Last updated: August 29, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention Phase
Basal Cell Carcinoma Drug: vismodegib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of participants who experienced any Adverse events (AEs), AEs Grade 3 or 4, AEs leading to drug interruptions or discontinuations and any Serious Adverse Events (SAEs) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 1226
Actual Study Start Date: July 1, 2011
Study Completion Date: June 14, 2017
Primary Completion Date: June 14, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: vismodegib
150 mg once daily until disease progression or unacceptable toxicity

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367665

  Show 182 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01367665     History of Changes
Other Study ID Numbers: MO25616
2011-000195-34 ( EudraCT Number )
Study First Received: May 30, 2011
Last Updated: August 29, 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on September 20, 2017