Can I participate?
To qualify for the TGCT trial, the patient must:
Have a confirmed diagnosis of Tenosynovial Giant Cell Tumor (TGCT) [also known as Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath]
Be ineligible for tumor removal surgery
Test negative for pregnancy (female participants of child-bearing potential)
Be 18 years of age or older
This is not a complete list of participation criteria and other inclusion/exclusion criteria may apply.
What 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
Why should I participate?
By enrolling in this Phase I trial:
You could potentially see effects of the study drug on your:
- • Range of motion and physical functioning
- • Daily living activities
- • Tumor size, pain, stiffness or swelling
You will help us understand:
- • The anti-tumor activity of the study drug on your disease
- • The effective and safe dose of the study drug, DCC-3014
- • If there are any side effects from taking DCC-3014
Your participation in this study will help researchers and doctors better understand DCC-3014 and its potential effects. This information may also benefit others with your condition in the future.
i'm interestedWhat’s the purpose of this clinical trial?
This study focuses on patients living with Tenosynovial Giant Cell Tumor (TGCT), also known as Pigmented Villonodular Synovitis (PVNS). This trial will study the effectiveness and safety of an investigational oral study drug (called “DCC-3014”) by assessing the drug's effects on your tumor response, range of motion (ROM), physical function and pain.
What’s involved?
1. Select “I’m Interested” and enter your information to express interest in the study.
2. A representative from our call center will then reach out to you and ask you a few questions about yourself and your condition and direct you to the nearest participating hospital.
3. The study staff will speak to you about the research study and Informed Consent Form (ICF). The ICF provides a description of the clinical trial, the procedures you will undergo during the study, and the known safety information of the study drug.
4. If you pre-qualify for the study, you will come to the clinic to sign the ICF and for your first screening visit.
5. You will receive the study drug (DCC-3014). The study team will evaluate the study medication’s potential effects on your tumor size, range of motion (ROM), and pain and physical functioning.
6. This is determined through clinic visits, MRI scans and patient questionnaires.
7. At all visits you will have a physical exam, be asked how you are feeling and if you are experiencing any symptoms, and your dosing diary will be reviewed.
The study doctor and study team will be available to answer any questions that you or your family might have.
Frequently Asked Questions (FAQs)
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.
This study is seeking to enroll TGCT patients including localized and diffuse-type TGCT.
The study drug, study-related procedures, and study visits will be provided at no cost to you or your insurance company.
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:
■ The United States
■ Canada
■ Australia
■ The United Kingdom
■ The United States
■ Canada
■ Australia
■ The United Kingdom
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.
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.
This study is seeking to enroll TGCT patients including localized and diffuse-type TGCT.
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.
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.
The study staff at the research site will provide specific details regarding any insurance requirements.