Tenosynovial Giant Cell Tumor Clinical Trial
Are you living with Tenosynovial Giant Cell Tumors (TGCT) or Pigmented Villonodular Synovitis (PVNS)?
If so, you may be eligible for a clinical trial
Are you living with Tenosynovial Giant Cell Tumors (TGCT) or Pigmented Villonodular Synovitis (PVNS)? If so, you may be eligible for a clinical trial
Frequently Asked Questions
What is Tenosynovial Giant Cell Tumor?
Tenosynovial Giant Cell Tumors (TGCT) are a group of non-cancerous (benign) tumors that involve the synovium, bursae and/or tendon sheath. Although benign, these tumors can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint. Surgery is the main treatment option; however, these tumors tend to recur, particularly in Pigmented Villonodular Synovitis (PVNS), a diffuse-type of TGCT. If untreated or if the tumor continually recurs, damage and degeneration may occur in the affected joint and surrounding tissues, which may cause significant disability.
This study is seeking to enroll TGCT patients including localized and diffuse-type TGCT.
Where is this trial conducted?
This trial is being conducted at multiple research site locations. Currently, there are active research sites enrolling patients in:
■Portland, OR, USA
■Denver, CO, USA
■Palo Alto, CA, USA
In the coming months, additional sites will open for enrollment:
■New York City, NY, USA
■Jacksonville, FL, USA
■Boston, MA, USA
■Other locations to be announced
How will the study drug be administered?
The study drug, DCC-3014, is a capsule that is taken orally.
Is there a risk that I will receive a placebo?
This study does not have a placebo so everyone participating in the study will receive the study drug.
Are there any costs for me to participate?
There will be no charge to you for your participation in this study.
The study drug, study-related procedures, and study visits will be provided at no cost to you or your insurance company.
Will I receive compensation?
You will not receive any payment for taking part in the study.
You may receive:
■Study-related treatment at no cost
■Medical treatment related to TGCT
■Travel reimbursement for clinic visits
■Lodging & meal reimbursement for clinic visits
The study staff at the research site may provide specific details regarding reimbursements for their site.
Can my companion or caregiver join me for clinic visits?
Yes. We may also be able to provide travel, lodging, and/or meal reimbursements for your caregiver or companion on a case-by-case basis.
Do I need insurance?
You may not need insurance to participate in the study.
The study staff at the research site will provide specific details regarding any insurance requirements.
Details for the study
Study Drug and/or Procedures
- 1. Male or female patients ≥ 18 years of age.
- 2. A confirmed diagnosis of Diffuse Tenosynovial Giant Cell Tumor (DTGCT) for which surgical removal is not an option.
- 3. Symptomatic disease with at least moderate pain within the past month.
- 4. Must have 1 measurable lesion according to RECIST Version 1.1.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- 6. Adequate liver function, kidney function, and bone marrow reserve.
- 7. Female patients of childbearing potential must have a negative pregnancy test prior to enrollment.
- 8. Ability to take oral medication.
- 9. Ability to understand and comply with the protocol and has signed the informed consent form (ICF).
- 1. Alternate treatment for DTGCT, within 2 weeks prior to the administration of study drug.
- 2. Unresolved toxicity (>Grade 1 or baseline) from any previous TGCT therapy.
- 3. Advanced heart disease, uncontrolled angina, cardiac arrhythmia, or uncontrolled hypertension.
- 4. Systemic venous or arterial thrombotic events within the past 6 months.
- 5. Concurrent treatment with proton-pump inhibitors.
- 6. Major surgery within 2 weeks of the first dose of study drug.
- 7. Known active central nervous system (CNS) metastases.
- 8. If female, patient is pregnant or lactating.
- 9. Known allergy or hypersensitivity to any component of the study drug.