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NCT01207492 · ClinicalTrials.gov registry record · Phase 2

Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor

A Phase 2 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, sponsored by Andrew J. Wagner, MD, PhD.

Completed
Registry status
Phase 2
Development phase
17
Enrollment target
7
Study locations

NCT01207492: Completed Phase 2 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, sponsored by Andrew J. Wagner, MD, PhD.

NCT01207492 is a Phase 2 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis that has completed, run by Andrew J. Wagner, MD, PhD. The registered enrollment target is 17 participants, below the 116-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (85% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01207492, a Phase 2 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, has completed, sponsored by Andrew J. Wagner, MD, PhD.

COMPLETED
Registry status
Phase 2
Development phase
17 participants
Enrollment target
7
Study locations

Study 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.

Primary Outcome

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.

Interventions

  • DRUG nilotinib

Study Locations (7)

California

  • Sarcoma Oncology Center - Santa Monica
  • Stanford University Medical Center - Stanford

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana-Farber Cancer Institute - Boston

Florida

  • H. Lee Moffitt Cancer Center - Tampa

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia

Texas

  • UT MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2010-09
Est. Completion 2015-08
Phase Phase 2
Andrew J. Wagner, MD, PhD

1 total trials

What the finished NCT01207492 record still lists

NCT01207492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 116-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (85% lower).

The record links to 3 conditions, with Tenosynovial Giant Cell Tumor appearing as the primary indexed condition, and to 1 intervention - of which nilotinib is the first listed.

NCT01207492 lists 7 locations in 5 states (California, Massachusetts, Florida).

Frequently Asked Questions

What is clinical trial NCT01207492 about?

NCT01207492 is a clinical study titled "Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor". 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 t...

What is the current status of trial NCT01207492?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2010-09. Estimated completion is 2015-08.

What conditions does trial NCT01207492 study?

This clinical trial studies the following conditions: Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Diffuse-type Giant Cell Tumor.

What interventions are being tested in trial NCT01207492?

The interventions under investigation include: nilotinib (DRUG).

Who is sponsoring clinical trial NCT01207492?

This trial is sponsored by Andrew J. Wagner, MD, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01207492 being conducted?

This trial has 7 study locations across California, Florida, Massachusetts, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Tenosynovial Giant Cell Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01207492's enrollment target sits among peer trials

17 9th of 8 the lowest of 8 other Tenosynovial Giant Cell Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Tenosynovial Giant Cell Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01207492, the US trial registry maintained by the National Library of Medicine. NCT01207492 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.