Trial · NCT01815840
A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas
NCT01815840, Phase 2, Completed, Hoffmann-La Roche; results first posted 2016-08-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas. Trials, record NCT01815840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01815840
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas
- NCT number
- NCT01815840
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 229 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Basal Cell Carcinoma
- Interventions
- Vismodegib, Placebo
- First posted
- 2013-03-21
- Last updated
- 2017-09-28
- Other registries' IDs
- eudract:2012-003305-10
- Results first posted
- 2016-08-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment) | Baseline; Week 73 | The total number of clinically evident basal cell carcinomas = the total number of target and/or non-target lesions present in individual participants. |
| Secondary | Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues | Baseline to Week 73 | The percentage of participants who discontinued study treatment (due either to adverse event, refusal of treatment, or withdrawal of consent) was summarized by treatment group. |
| Secondary | Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at Week 73 | Baseline; Week 73 | The three target basal cell carcinoma lesions = the three largest visible lesions, at least 5 mm in the longest diameter, in individual participants. |
| Secondary | Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73 | Baseline; Week 73 | |
| Secondary | Percentage of Participants With New Basal Cell Carcinomas at Week 73 | Baseline; Week 73 | |
| Secondary | Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 85 (12 Weeks Following End of Treatment) (Recurrence Rate) | Baseline; Week 85 | |
| Secondary | Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate) | Baseline; Week 97 | |
| Secondary | Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate) | Baseline; Week 125 | |
| Secondary | Percentage of Participants Experiencing Any Adverse Event | Up to 125 weeks | |
| Secondary | Percent Change From Baseline in the Skindex-16 Symptom Domain Score at Week 73 | Baseline; Week 73 | The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their symptoms, and their answers were combined into a composite Symptom Domain Score. Scores range from 0 ("never bothered") to 100 ("always bothered"). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment) | Baseline; Week 73 | Participants in the Intent-to-Treat analysis population (defined as all randomized participants) with available data were included in the analysis. The last observation carried forward method was used. | percent change | MEAN |
| SECONDARY | Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues | Baseline to Week 73 | Intent-to-Treat Analysis Population, defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at Week 73 | Baseline; Week 73 | Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis. | percent change | MEAN |
| SECONDARY | Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73 | Baseline; Week 73 | Intent-to-Treat Analysis Population, defined as all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With New Basal Cell Carcinomas at Week 73 | Baseline; Week 73 | Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 85 (12 Weeks Following End of Treatment) (Recurrence Rate) | Baseline; Week 85 | Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis. | percent change | MEAN |
| SECONDARY | Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate) | Baseline; Week 97 | Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis. | percent change | MEAN |
| SECONDARY | Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate) | Baseline; Week 125 | Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis. | percent change | MEAN |
| SECONDARY | Percentage of Participants Experiencing Any Adverse Event | Up to 125 weeks | Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in the Skindex-16 Symptom Domain Score at Week 73 | Baseline; Week 73 | Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis. | percent change | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment) | Vismodegib Intermittent Schedule | 62.9 | Standard Deviation 52.01 | percent change | |
| Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment) | Vismodegib Induction Followed by Intermittent Schedule | 54.9 | Standard Deviation 54.85 | percent change | |
| Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues | Vismodegib Intermittent Schedule | Overall | 37.1 | 95% Confidence Interval 28.3 to 46.5 | percentage of participants |
| Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues | Vismodegib Induction Followed by Intermittent Schedule | Overall | 41.6 | 95% Confidence Interval 32.4 to 51.2 | percentage of participants |
| Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues | Vismodegib Intermittent Schedule | Adverse Events | 20.7 | 95% Confidence Interval 13.7 to 29.2 | percentage of participants |
| Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues | Vismodegib Induction Followed by Intermittent Schedule | Adverse Events | 27.4 | 95% Confidence Interval 19.5 to 36.6 | percentage of participants |
| Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues | Vismodegib Intermittent Schedule | Refused Treatment | 6.0 | 95% Confidence Interval 2.5 to 12.0 | percentage of participants |
| Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues | Vismodegib Induction Followed by Intermittent Schedule | Refused Treatment | 2.7 | 95% Confidence Interval 0.6 to 7.6 | percentage of participants |
| Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues | Vismodegib Intermittent Schedule | Withdrew Consent | 10.3 | 95% Confidence Interval 5.5 to 17.4 | percentage of participants |
| Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues | Vismodegib Induction Followed by Intermittent Schedule | Withdrew Consent | 11.5 | 95% Confidence Interval 6.3 to 18.9 | percentage of participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 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 Intermittent Schedule | 116 | |
| Overall Study | STARTED | Vismodegib Induction Followed by Intermittent Schedule | 113 | |
| Overall Study | COMPLETED | Vismodegib Intermittent Schedule | 57 | |
| Overall Study | COMPLETED | Vismodegib Induction Followed by Intermittent Schedule | 50 | |
| Overall Study | NOT COMPLETED | Vismodegib Intermittent Schedule | 59 | |
| Overall Study | NOT COMPLETED | Vismodegib Induction Followed by Intermittent Schedule | 63 |
Source ClinicalTrials.gov
Adverse events186
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 | Muscle spasms | Musculoskeletal and connective tissue disorders | Vismodegib Intermittent Schedule | 83 | 114 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Vismodegib Induction Followed by Intermittent Schedule | 94 | 113 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Vismodegib Intermittent Schedule | 18 | 114 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Vismodegib Induction Followed by Intermittent Schedule | 16 | 113 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Vismodegib Intermittent Schedule | 18 | 114 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Vismodegib Induction Followed by Intermittent Schedule | 12 | 113 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Vismodegib Intermittent Schedule | 7 | 114 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Vismodegib Induction Followed by Intermittent Schedule | 7 | 113 | |
| other | Dysgeusia | Nervous system disorders | Vismodegib Intermittent Schedule | 76 | 114 | |
| other | Dysgeusia | Nervous system disorders | Vismodegib Induction Followed by Intermittent Schedule | 75 | 113 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vismodegib Intermittent Schedule | ||
| Total, all-cause mortality | Vismodegib Induction Followed by Intermittent Schedule | ||
| Total, other adverse events | Vismodegib Intermittent Schedule | 107 | 114 |
| Total, other adverse events | Vismodegib Induction Followed by Intermittent Schedule | 108 | 113 |
| Total, serious adverse events | Vismodegib Intermittent Schedule | 24 | 114 |
| Total, serious adverse events | Vismodegib Induction Followed by Intermittent Schedule | 23 | 113 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vismodegib Intermittent Schedule vs Vismodegib Induction Followed by Intermittent Schedule: serious adverse events |
Source 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/NCT01815840
GET https://conductscience.org/api/trials/v1/NCT01815840/results?page=2