Trial · NCT01207492
Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor
NCT01207492, Phase 2, Completed, Andrew J. Wagner, MD, PhD; results first posted 2015-06-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor. Trials, record NCT01207492. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01207492
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor
- NCT number
- NCT01207492
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Andrew J. Wagner, MD, PhD
- Conditions
- Pigmented Villonodular Synovitis, Diffuse-type Giant Cell Tumor, Tenosynovial Giant Cell Tumor
- Interventions
- nilotinib
- First posted
- 2010-09-23
- Last updated
- 2026-11-10
- Results first posted
- 2015-06-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Progression Free Survival | 6 months | To estimate progression free survival at 6 months in participants with recurrent PVNS treated with nilotinib. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Overall Tumor Response Rate (OR) | 2 years | To determine overall tumor response rate \[% complete response (CR) + % partial response (PR) by RECIST 1.1\]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR) is a disappearance of all target lesions. Partial Response (PR) is a \>=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR. |
| Secondary | Clinical Benefit Rate | 6 months | To determine the clinical benefit rate \[% CR + % PR + % stable disease by RECIST 1.1\] at 6 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR) is a disappearance of all target lesions. Partial Response (PR) is a \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Progression Free Survival | 6 months | percentage of participants with PFS | NUMBER | |
| SECONDARY | Overall Tumor Response Rate (OR) | 2 years | percentage of participants | NUMBER | |
| SECONDARY | Clinical Benefit Rate | 6 months | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Progression Free Survival | Nilotinib | 82 | 95% Confidence Interval 57 to 96 | percentage of participants with PFS | |
| Overall Tumor Response Rate (OR) | Nilotinib | 0 | 95% Confidence Interval 0 to 20 | percentage of participants | |
| Clinical Benefit Rate | Nilotinib | 47 | 95% Confidence Interval 23 to 72 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nilotinib | 17 | |
| Overall Study | COMPLETED | Nilotinib | 2 | |
| Overall Study | NOT COMPLETED | Nilotinib | 15 |
Source ClinicalTrials.gov
Adverse events57
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 | Gastroesophageal reflux disease | Gastrointestinal disorders | Nilotinib | 2 | 17 | |
| other | Lung infection | Infections and infestations | Nilotinib | 1 | 17 | |
| other | Restlessness | Psychiatric disorders | Nilotinib | 1 | 17 | |
| other | Hoarseness | Respiratory, thoracic and mediastinal disorders | Nilotinib | 1 | 17 | |
| other | Sore throat | Respiratory, thoracic and mediastinal disorders | Nilotinib | 1 | 17 | |
| other | Anemia | Blood and lymphatic system disorders | Nilotinib | 3 | 17 | |
| other | Chest pain - cardiac | Cardiac disorders | Nilotinib | 1 | 17 | |
| other | Scleral disorder | Eye disorders | Nilotinib | 1 | 17 | |
| other | Eye disorders - Other, specify | Eye disorders | Nilotinib | 3 | 17 | |
| other | Abdominal pain | Gastrointestinal disorders | Nilotinib | 2 | 17 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nilotinib | ||
| Total, other adverse events | Nilotinib | 17 | 17 |
| Total, serious adverse events | Nilotinib | 2 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01207492
GET https://conductscience.org/api/trials/v1/NCT01207492/events?page=2