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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01367665
First received: May 30, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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: 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:

MedlinePlus related topics: Cancer
Drug Information available for: Vismodegib
U.S. FDA Resources

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:
  • 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: June 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367665

Contacts
Contact: Please reference Study ID Number: MO25616 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 194 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: May 13, 2013
Health Authority: France: Agence Francaise de securite sanitaire des produits de sante

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 May 16, 2013