Trial · NCT01267955
Vismodegib in Treating Patients With Advanced Chondrosarcomas
NCT01267955, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2019-11-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vismodegib in Treating Patients With Advanced Chondrosarcomas. Trials, record NCT01267955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01267955
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vismodegib in Treating Patients With Advanced Chondrosarcomas
- NCT number
- NCT01267955
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Clear Cell Chondrosarcoma, Dedifferentiated Chondrosarcoma, Locally Advanced Chondrosarcoma, Mesenchymal Chondrosarcoma, Metastatic Chondrosarcoma, Primary Central Chondrosarcoma, Unresectable Primary Central Chondrosarcoma
- Interventions
- Laboratory Biomarker Analysis, Pharmacogenomic Study, Vismodegib
- First posted
- 2010-12-29
- Last updated
- 2026-08-13
- Results first posted
- 2019-11-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Benefit Rate (CBR) Based on Centralized Imaging Review as Per RECIST 1.1 | At 6 months after inclusion | CBR was defined as the percentage of participants with complete or partial responses (CR, PR) or stable disease (SD) per RECIST 1.1. CR was defined as disappearance of all non-nodal target lesions. PR was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Analysis of response was performed based on radiological centralized review. A 2-stage optimal Simon's design with 37 participants (first stage: 17 participants) was used. If 3 or less non-progressions (CR + PR + SD) at 6 months were observed during stage 1 (out of 17 participants), the trial would stopped early. Otherwise, 20 additional patients would be accrued for stage 2. If 11 or more non-progressions (out of 37 participants) were observed at the end of recruitment, further investigation of this therapy would be warranted. |
| Secondary | Progression-free Survival | Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years | Will be analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method. |
| Secondary | Overall Survival Per Response Evaluation Criteria in Solid Tumors Criteria 2009 | Time from start of treatment to the time of death, assessed up to 3 years | Overall survival will be analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method. |
| Secondary | Duration of Response | From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years | Will be described in responding subjects using descriptive statistics (median, extreme values, etc.). |
| Secondary | Mutational Status of Patched 1 and Smoothened | Baseline | The 6-months clinical benefit rate will be correlated with the mutational status of patched and smoothened in order to identify predictive factors of clinical benefit from vismodegib. |
| Secondary | Expression Pattern of Hedgehog Signaling Molecules by Using Quantitative Reverse Transcription-polymerase Chain Reaction and Immunohistochemistry | Baseline | The 6-months clinical benefit rate will be correlated with the expression score of hedgehog signaling molecules in order to identify predictive factors of clinical benefit from vismodegib. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Benefit Rate (CBR) Based on Centralized Imaging Review as Per RECIST 1.1 | At 6 months after inclusion | Eligible participants with at least one complete or two incomplete cycles of treatment and for whom at least one disease measurement has been recorded not less than 8 weeks after treatment onset. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival | Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years | |||
| SECONDARY | Overall Survival Per Response Evaluation Criteria in Solid Tumors Criteria 2009 | Time from start of treatment to the time of death, assessed up to 3 years | |||
| SECONDARY | Duration of Response | From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years | |||
| SECONDARY | Mutational Status of Patched 1 and Smoothened | Baseline | |||
| SECONDARY | Expression Pattern of Hedgehog Signaling Molecules by Using Quantitative Reverse Transcription-polymerase Chain Reaction and Immunohistochemistry | Baseline |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Benefit Rate (CBR) Based on Centralized Imaging Review as Per RECIST 1.1 | Treatment (Vismodegib) | First stage | 23.5 | 95% Confidence Interval 6.8 to 49.9 | percentage of participants |
| Clinical Benefit Rate (CBR) Based on Centralized Imaging Review as Per RECIST 1.1 | Treatment (Vismodegib) | Second stage (Overall) | 25.6 | 95% Confidence Interval 13.0 to 42.1 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Stage 1 (6 Months) | STARTED | Treatment (Vismodegib) | 20 | |
| Stage 1 (6 Months) | COMPLETED | Treatment (Vismodegib) | 17 | |
| Stage 1 (6 Months) | NOT COMPLETED | Treatment (Vismodegib) | 3 | |
| Stage 2 (6 Months) | STARTED | Treatment (Vismodegib) | 45 | |
| Stage 2 (6 Months) | COMPLETED | Treatment (Vismodegib) | 39 | |
| Stage 2 (6 Months) | NOT COMPLETED | Treatment (Vismodegib) | 6 |
Source ClinicalTrials.gov
Adverse events73
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 | ANEMIA | Blood and lymphatic system disorders | Treatment (Vismodegib) | 9 | 45 | 15 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Treatment (Vismodegib) | 3 | 45 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Vismodegib) | 9 | 45 | 9 |
| other | Constipation | Gastrointestinal disorders | Treatment (Vismodegib) | 8 | 45 | 10 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Vismodegib) | 13 | 45 | 19 |
| other | Dry mouth | Gastrointestinal disorders | Treatment (Vismodegib) | 3 | 45 | 3 |
| other | Gastroesophageal reflux disease | Gastrointestinal disorders | Treatment (Vismodegib) | 3 | 45 | 3 |
| other | Mucositis oral | Gastrointestinal disorders | Treatment (Vismodegib) | 3 | 45 | 3 |
| other | Nausea | Gastrointestinal disorders | Treatment (Vismodegib) | 17 | 45 | 20 |
| other | Stomach pain | Gastrointestinal disorders | Treatment (Vismodegib) | 3 | 45 | 5 |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Vismodegib) | 23 | 45 |
| Total, other adverse events | Treatment (Vismodegib) | 45 | 45 |
| Total, serious adverse events | Treatment (Vismodegib) | 22 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24170610 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01267955
GET https://conductscience.org/api/trials/v1/NCT01267955/events?page=2