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

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ClinicalTrials.gov Identifier: NCT01367665
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Drug: vismodegib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1226 participants
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)
Actual Study Start Date : July 1, 2011
Actual Primary Completion Date : June 14, 2017
Actual Study Completion Date : June 14, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Vismodegib

Arm Intervention/treatment
Experimental: Single Arm Drug: vismodegib
150 mg once daily until disease progression or unacceptable toxicity




Primary Outcome Measures :
  1. 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 :
  1. Quality of life: Skindex-16 questionnaire [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  2. Symptoms in metastatic BCC patients: M.D. Anderson Symptom Inventory (MDASI) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  3. Tumor response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  4. Time to response [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  5. Duration of response [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  6. Progression-free survival [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  7. Overall survival [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367665


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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche