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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pigmented Villonodular Synovitis, Diffuse-type Giant Cell Tumor, Tenosynovial Giant Cell Tumor

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Trial Information

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


- 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.


Inclusion Criteria:



- Histologically confirmed diagnosis of recurrent PVNS ( or diffuse-type giant cell
tumor or tenosynovial giant cell tumor) that is unresectable, metastatic, or for
which the patient refuses surgical intervention

- Progressive disease in the last 12 months, as demonstrated by imaging or clinical
appearance of new tumors, in the opinion of the treating investigator

- At least one site of measurable disease according to RECIST 1.1 on MRI (or CT scan
for metastatic disease)

- Any number or type of prior systemic therapies, with the exception of known or
suspected CSF1 receptor inhibitors as outlined in exclusion criteria below

- 18 years of age or older

- Life expectancy greater than 6 months

- ECOG Performance Status of 0, 1 or 2

- Normal organ and marrow function as defined in the protocol

- QTc less than or equal to 450 ms on 12-lead ECG

- Negative urine or serum pregnancy test within days of start of study drug
administration for women of childbearing potential.

- Women of childbearing potential and men must agree to use adequate contraception
prior to study entry, for the duration of study participation, and for 3 months
following study drug discontinuation

Exclusion Criteria:

- Prior treatment with known or suspected CSF1 receptor inhibitor, including nilotinib,
imatinib, sunitinib, or sorafenib, or other approved or investigational tyrosine
kinase inhibitors used for treatment of diffuse-type giant cell tumor

- Concurrent treatment with other investigational agents

- Inability to tolerate or contraindication to MRI scanning for participants with
localized disease

- Impaired cardiac function

- Current treatment with strong CYP3A4 inhibitors that cannot either be discontinued or
switched to a different medication prior to starting study drug

- Current treatment with any medications that have the potential to prolong the QT
interval and that cannot either be discontinued or switched to a different medication
prior to starting study drug

- Impaired gastrointestinal (GI) function or GI disease that may significantly alter
the absorption of study drug

- Acute or chronic pancreatic disease

- Acute or chronic liver disease

- Another primary malignant disease requiring systemic treatment or radiation

- History of significant congenital or acquired bleeding disorder unrelated to cancer

- Major surgery within 28 days prior to Day 1 of the study

- Treatment with other investigational agents within 28 days of day 1

- History of non-compliance to medical regimens or inability to grant consent

- Women who are pregnant or breastfeeding

- Other comorbidities that would interfere with study participation or safety in the
opinion of the investigator

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Description:

To estimate progression free survival at 6 months in participants with recurrent PVNS treated with nilotinib.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Andrew J. Wagner, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

10-179

NCT ID:

NCT01207492

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Pigmented Villonodular Synovitis
  • Diffuse-type Giant Cell Tumor
  • Tenosynovial Giant Cell Tumor
  • nilotinib
  • Giant Cell Tumors
  • Synovitis
  • Synovitis, Pigmented Villonodular

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
H. Lee Moffitt Cancer CenterTampa, Florida  33612
UT MD Anderson Cancer CenterHouston, Texas  77030
Sarcoma Oncology CenterSanta Monica, California  90403