Phase 2
N=1,215
STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Basal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01367665 ↗Enrolled (actual)
1,215
Serious AEs
24.9%
Results posted
Jun 2019
Primary outcome: Primary: 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) — 98.4; 99.0; 43.4; 52.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- vismodegib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
98.4; 99.0; 43.4; 52.1; 24.3; 32.3 | — |
| PRIMARY Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons |
6.1; 6.3; 1.9; 13.5; 1.3; 0 | — |
| PRIMARY Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters |
0.1; 0; 1.3; 2.1; 0.5; 0 | — |
| PRIMARY Exposure to Study Treatment: Duration on Treatment |
256.0; 337.0 | — |
| PRIMARY Exposure to Study Treatment - Dose Intensity |
97.62; 98.51 | — |
| SECONDARY Best Overall Response Rate (BORR) |
33.9; 4.8; 35.3; 32.5 | — |
| SECONDARY Duration of Response |
18.89; 13.93 | — |
| SECONDARY Time to Response |
3.65; NA | — |
| SECONDARY Progression-Free Survival (PFS) |
20.30; 12.85 | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom |
-18.02; -8.68; -26.04; -13.14; -24.66; 7.76 | — |
| SECONDARY Percentage of Participants With a ≥ 30% Reduction in Disease-Related Symptoms According to MDASI Scale |
60.0 | — |
| SECONDARY Percentage of Participants With a ≥ 30% Reduction in Composite Symptom Severity Score According to MDASI Scale |
33.3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01367665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.