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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01367665
First received: May 30, 2011
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This single-arm, open-label, multi-center study will evaluate the safety and eff icacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic b asal 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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • Safety: Incidence of adverse events [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life: Skindex-16 questionnaire [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
  • Symptoms in metastatic BCC patients: M.D. Anderson Symptom Inventory (MDASI) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
  • Tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: July 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Reference Study ID Number: MO25616 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 185 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01367665     History of Changes
Other Study ID Numbers: MO25616, 2011-000195-34
Study First Received: May 30, 2011
Last Updated: November 24, 2014
Health Authority: France: Agence Francaise de securite sanitaire des produits de sante

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

ClinicalTrials.gov processed this record on November 25, 2014