Trials / Completed
CompletedNCT01207492
Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor
A Multi-Center Single Agent Phase II Study of the Efficacy of Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Andrew J. Wagner, MD, PhD · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Nilotinib is a drug that is used to treat a form of a blood cancer called leukemia. Nilotinib works by blocking the action of a protein that might be important for the growth of pigmented villonodular synovitis (PVNS). In this research study the investigators are testing whether nilotinib can stop the growth of PVNS or improve the symptoms experienced from PVNS.
Detailed description
* In this research study, each cycle of study drug dosing will last 4 weeks (28 days). During each cycle, participants will take nilotinib by mouth twice daily. During the first cycle, participants will come to the clinic on Days 1 and 8. For Cycles 2-4 and every 3 cycles thereafter, they will come to the clinic on Day 1. * The following tests and procedures will be performed at specific time points during study treatment: MRI or CT scans; physical examinations; vital signs; blood work; questionnaires and EKG. * Participants may continue in this research study for as long as they do not have serious side effects or their disease does not get worse.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nilotinib | Taken orally twice daily |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2014-04-01
- Completion
- 2015-08-01
- First posted
- 2010-09-23
- Last updated
- 2026-02-20
- Results posted
- 2015-06-25
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01207492. Inclusion in this directory is not an endorsement.