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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01367665
Registration number
NCT01367665
Ethics application status
Date submitted
30/05/2011
Date registered
7/06/2011
Date last updated
6/06/2019
Titles & IDs
Public title
STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
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Scientific 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)
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Secondary ID [1]
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0
2011-000195-34
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Secondary ID [2]
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MO25616
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Basal Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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0
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - vismodegib
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
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
Treatment: Drugs: vismodegib
150 mg once daily until disease progression or unacceptable toxicity
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to the data cut-off of 14 June 2017 (up to 6 years)
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Primary outcome [2]
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Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons
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Assessment method [2]
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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)."
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Timepoint [2]
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Baseline to the data cut-off of 14 June 2017 (up to 6 years)
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Primary outcome [3]
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Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters
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Assessment method [3]
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Timepoint [3]
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Baseline to the data cut-off of 14 June 2017 (up to 6 years)
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Primary outcome [4]
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Exposure to Study Treatment: Duration on Treatment
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Assessment method [4]
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Duration on treatment was the number of days between first and last dose of study treatment.
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Timepoint [4]
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Baseline to the data cut-off of 14 June 2017 (up to 6 years)
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Primary outcome [5]
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Exposure to Study Treatment - Dose Intensity
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Assessment method [5]
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Dose intensity was defined as the percentage of actual number of doses received versus planned.
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Timepoint [5]
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Baseline to the data cut-off of 14 June 2017 (up to 6 years)
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Secondary outcome [1]
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Best Overall Response Rate (BORR)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to the data cut-off of 14 June 2017 (up to 6 years)
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to the data cut-off of 14 June 2017 (up to 6 years)
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Secondary outcome [3]
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Time to Response
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Assessment method [3]
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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).
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Timepoint [3]
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Baseline to the data cut-off of 14 June 2017 (up to 6 years)
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Secondary outcome [4]
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Progression-Free Survival (PFS)
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline to the data cut-off of 14 June 2017 (up to 6 years)
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.
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Timepoint [5]
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Baseline to the data cut-off of 14 June 2017 (up to 6 years)
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Secondary outcome [6]
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Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom
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Assessment method [6]
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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).
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Timepoint [6]
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Baseline to the data cut-off date of 14 June 2017 (up to 6 years).
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Secondary outcome [7]
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Percentage of Participants With a = 30% Reduction in Disease-Related Symptoms According to MDASI Scale
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Assessment method [7]
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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.
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Timepoint [7]
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08-May-2013 (Protocol Version = 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).
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Secondary outcome [8]
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Percentage of Participants With a = 30% Reduction in Composite Symptom Severity Score According to MDASI Scale
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Assessment method [8]
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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.
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Timepoint [8]
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08-May-2013 (Protocol Version = 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/06/2017
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Sample size
Target
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Accrual to date
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Final
1232
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Premier Specialists - Kogarah
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Recruitment hospital [2]
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Skin and Cancer Foundation Australia - Westmead
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Recruitment hospital [3]
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CMAX A division of IDT Australia Limited - Adelaide
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Recruitment hospital [4]
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Skin & Cancer Foundation - Carlton
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3053 - Carlton
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Recruitment outside Australia
Country [1]
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Argentina
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Buenos Aires
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Austria
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Graz
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Austria
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Salzburg
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Austria
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St. Pölten
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Austria
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Wien
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Belgium
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Leuven
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Bosnia and Herzegovina
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Banja Luka
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Bosnia and Herzegovina
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Sarajevo
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Brazil
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RS
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Brazil
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SP
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Bulgaria
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Plovdiv
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Sofia
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Ontario
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Bogota
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Cali
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Medellin-Antioquia
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Medellin
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Toulouse
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Nürnberg
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Regensburg
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Tübingen
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Szeged
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Cork
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Halfa
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Italy
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Abruzzo
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Italy
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Piemonte
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Italy
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Sardegna
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Toscana
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Veneto
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Vilnius
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Mexico
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Groningen
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Funding & Sponsors
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Hoffmann-La Roche
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01367665
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01367665
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