Trial · NCT01367665
STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
NCT01367665, Phase 2, Completed, Hoffmann-La Roche; results first posted 2019-06-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma. Trials, record NCT01367665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01367665
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
- NCT number
- NCT01367665
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,232 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Basal Cell Carcinoma
- Interventions
- vismodegib
- First posted
- 2011-06-07
- Last updated
- 2019-06-06
- Other registries' IDs
- eudract:2011-000195-34
- Results first posted
- 2019-06-06
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | 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. |
| Primary | Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons | 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)." |
| Primary | Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | |
| Primary | Exposure to Study Treatment: Duration on Treatment | 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. |
| Primary | Exposure to Study Treatment - Dose Intensity | 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 | Best Overall Response Rate (BORR) | 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. |
| Secondary | Duration of Response | 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. |
| Secondary | Time to Response | 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). |
| Secondary | Progression-Free Survival (PFS) | 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. |
| Secondary | Overall Survival (OS) | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | percentage of participants | NUMBER | |
| PRIMARY | Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | percentage of participants | NUMBER | |
| PRIMARY | Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | percentage of participants | NUMBER | |
| PRIMARY | Exposure to Study Treatment: Duration on Treatment | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | days | MEDIAN | |
| PRIMARY | Exposure to Study Treatment - Dose Intensity | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | percentage of doses | MEDIAN | |
| SECONDARY | Best Overall Response Rate (BORR) | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | Only included participants that had histologically confirmed measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | Only included participants that had histologically confirmed disease, measureable disease status at baseline (measureable or non-measureable) and reported a response of CR or PR. | months | MEDIAN |
| SECONDARY | Time to Response | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | Only included participants that had histologically confirmed measurable disease at baseline. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | Only included participants that had histologically confirmed disease and measureable disease status at baseline (measureable or non-measureable). | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | Only included participants that had histologically confirmed disease and measureable disease status at baseline (measureable or non-measureable). | months | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Vismodegib - Locally Advanced | Any AEs | 98.4 | percentage of participants | |
| 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) | Vismodegib - Metastatic | Any AEs | 99.0 | percentage of participants | |
| 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) | Vismodegib - Locally Advanced | Any AEs with maximum severity of Grade 3 or 4 | 43.4 | percentage of participants | |
| 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) | Vismodegib - Metastatic | Any AEs with maximum severity of Grade 3 or 4 | 52.1 | percentage of participants | |
| 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) | Vismodegib - Locally Advanced | Any Serious AEs | 24.3 | percentage of participants | |
| 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) | Vismodegib - Metastatic | Any Serious AEs | 32.3 | percentage of participants | |
| 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) | Vismodegib - Locally Advanced | Any AEs leading to study drug interruption | 40.5 | percentage of participants | |
| 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) | Vismodegib - Metastatic | Any AEs leading to study drug interruption | 35.4 | percentage of participants | |
| 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) | Vismodegib - Locally Advanced | Any AEs leading to study drug discontinuation | 33.8 | percentage of participants | |
| 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) | Vismodegib - Metastatic | Any AEs leading to study drug discontinuation | 17.7 | percentage of participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vismodegib - Locally Advanced | 1,119 | |
| Overall Study | STARTED | Vismodegib - Metastatic | 96 | |
| Overall Study | COMPLETED | Vismodegib - Locally Advanced | 677 | |
| Overall Study | COMPLETED | Vismodegib - Metastatic | 41 | |
| Overall Study | NOT COMPLETED | Vismodegib - Locally Advanced | 442 | |
| Overall Study | NOT COMPLETED | Vismodegib - Metastatic | 55 |
Source ClinicalTrials.gov
Adverse events622
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Vismodegib - Locally Advanced | 78 | 1,119 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Vismodegib - Metastatic | 8 | 96 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Vismodegib - Locally Advanced | 64 | 1,119 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Vismodegib - Metastatic | 6 | 96 | |
| other | CONSTIPATION | Gastrointestinal disorders | Vismodegib - Locally Advanced | 107 | 1,119 | |
| other | CONSTIPATION | Gastrointestinal disorders | Vismodegib - Metastatic | 14 | 96 | |
| other | DIARRHOEA | Gastrointestinal disorders | Vismodegib - Locally Advanced | 183 | 1,119 | |
| other | DIARRHOEA | Gastrointestinal disorders | Vismodegib - Metastatic | 18 | 96 | |
| other | NAUSEA | Gastrointestinal disorders | Vismodegib - Locally Advanced | 197 | 1,119 | |
| other | NAUSEA | Gastrointestinal disorders | Vismodegib - Metastatic | 24 | 96 |
1 to 10 of 622Source ClinicalTrials.gov
See all 622 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vismodegib - Locally Advanced | 103 | 1,119 |
| Total, all-cause mortality | Vismodegib - Metastatic | 19 | 96 |
| Total, other adverse events | Vismodegib - Locally Advanced | 1,065 | 1,119 |
| Total, other adverse events | Vismodegib - Metastatic | 90 | 96 |
| Total, serious adverse events | Vismodegib - Locally Advanced | 272 | 1,119 |
| Total, serious adverse events | Vismodegib - Metastatic | 31 | 96 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vismodegib - Locally Advanced vs Vismodegib - Metastatic: deaths from any cause | Trial comparisons |
| Vismodegib - Locally Advanced vs Vismodegib - Metastatic: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01367665
GET https://conductscience.org/api/trials/v1/NCT01367665/results?page=2