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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01367665
Recruitment Status : Completed
First Posted : June 7, 2011
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1232 participants
Allocation: Non-Randomized
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

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vismodegib - Locally Advanced
Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. vismodegib: 150 mg once daily until disease progression or unacceptable toxicity
 Drug: vismodegib
150 mg once daily until disease progression or unacceptable toxicity
Experimental: Vismodegib - Metastatic
Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. vismodegib: 150 mg once daily until disease progression or unacceptable toxicity
 Drug: vismodegib
150 mg once daily until disease progression or unacceptable toxicity


Outcome Measures
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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: Baseline to the data cut-off of 14 June 2017 (up to 6 years) ]
    Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival.

  2. Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons [ Time Frame: Baseline to the data cut-off of 14 June 2017 (up to 6 years) ]
    Reasons for "other" included "unknown," "natural causes," "cardiac decompensation," "general state alteration," "deterioration of general state," "clinical deterioration taking into consideration patient's age," "old age," and "disease progression of mediastinal squamous cell carcinoma (SCC)."

  3. Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters [ Time Frame: Baseline to the data cut-off of 14 June 2017 (up to 6 years) ]
  4. Exposure to Study Treatment: Duration on Treatment [ Time Frame: Baseline to the data cut-off of 14 June 2017 (up to 6 years) ]
    Duration on treatment was the number of days between first and last dose of study treatment.

  5. Exposure to Study Treatment - Dose Intensity [ Time Frame: Baseline to the data cut-off of 14 June 2017 (up to 6 years) ]
    Dose intensity was defined as the percentage of actual number of doses received versus planned.


Secondary Outcome Measures :
  1. Best Overall Response Rate (BORR) [ Time Frame: Baseline to the data cut-off of 14 June 2017 (up to 6 years) ]
    BORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) required a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  2. Duration of Response [ Time Frame: Baseline to the data cut-off of 14 June 2017 (up to 6 years) ]
    Duration of response was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of disease progression or death for any cause. Median duration of response was estimated using Kaplan-Meier estimates.

  3. Time to Response [ Time Frame: Baseline to the data cut-off of 14 June 2017 (up to 6 years) ]
    Time to response was defined as the interval between the date of first treatment and the date of first documentation of confirmed CR or PR (whichever occur first).

  4. Progression-Free Survival (PFS) [ Time Frame: Baseline to the data cut-off of 14 June 2017 (up to 6 years) ]
    PFS was defined as the time interval between the date of the first therapy and the date of progression or death for any causes, whichever occurs first. Disease progression was assessed by the investigator.

  5. Overall Survival (OS) [ Time Frame: Baseline to the data cut-off of 14 June 2017 (up to 6 years) ]
    OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.

  6. Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom [ Time Frame: Baseline to the data cut-off date of 14 June 2017 (up to 6 years). ]
    The Skindex-16 questionnaire includes three domains for the assessment of the effects of skin disease on participants' quality of life: symptoms, emotions and function. For each domain, responses from the questionnaire were transformed to a linear scale of 100 varying from 0 (never bothered, i.e., best) to 100 (always bothers, i.e., worst).

  7. Percentage of Participants With a ≥ 30% Reduction in Disease-Related Symptoms According to MDASI Scale [ Time Frame: 08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month). ]
    M.D. Anderson Symptom Inventory (MDASI) scale. The MDASI core instrument is a 19-item patient self-report questionnaire whose items comprise two scales, symptom severity and symptom interference. For 13 items (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness or tingling), participants were asked to rate how severe the symptoms were when "at their worst" in the last 24 hours. For the remaining 6 items, participants were asked to rate how much the symptoms have interfered with 6 areas of functioning (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours.

  8. Percentage of Participants With a ≥ 30% Reduction in Composite Symptom Severity Score According to MDASI Scale [ Time Frame: 08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month). ]
    M.D. Anderson Symptom Inventory (MDASI) scale. The MDASI core instrument is a 19-item patient self-report questionnaire whose items comprise two scales, symptom severity and symptom interference. For 13 items (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness or tingling), participants were asked to rate how severe the symptoms were when "at their worst" in the last 24 hours. For the remaining 6 items, participants were asked to rate how much the symptoms have interfered with 6 areas of functioning (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours.


Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:
Study Protocol  [PDF] April 4, 2016
Statistical Analysis Plan  [PDF] September 14, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01367665    
Other Study ID Numbers: MO25616
2011-000195-34 ( EudraCT Number )
First Posted: June 7, 2011    Key Record Dates
Results First Posted: June 6, 2019
Last Update Posted: June 6, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell