Tenosynovial Giant Cell Tumor Clinical Trial
Are you living with Tenosynovial Giant Cell Tumors (TGCT)?
If so, you may be eligible for a clinical trial
Are you living with Tenosynovial Giant Cell Tumors (TGCT)? If so, you may be eligible for a clinical trial
Research Site in Jacksonville, FL
Active not recruiting Jacksonville, FL, USA
Research Site in New York City, NY
Active not recruiting New York, NY, USA
Research Site in Toronto, ON
Active not recruiting Toronto, Ontario, CAN
Frequently Asked Questions
What is Tenosynovial Giant Cell Tumor?
Tenosynovial Giant Cell Tumors (TGCT) are a group of 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 tends to recur, particularly in pigmented villonodular synovitis, 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 diffuse TGCT patients.
Where is this trial conducted?
This trial is being conducted at multiple research site locations. Currently, there are research sites located in Portland, OR and Denver, CO. There are also sites that are currently in the process of opening in New York City, Palo Alto, CA, Jacksonville, FL, Toronto, Canada, and other locations in the coming months.
How will the study drug be administered?
The study drug, DCC-3014, is a capsule that is administered orally.
Is there a risk that I will receive a placebo?
This study doesn’t have a placebo so everyone participating in the study will receive the study drug.
Details for the study
Treatments and/or Procedures
Inclusion Criteria: 1. Patients ≥18 years of age 2. Patients must have advanced solid tumors or symptomatic DTGCT for which surgical resection is not an option 3. Able to provide a tumor tissue sample 4. Must have 1 measurable lesion according to RECIST Version 1.1 5. Must have ECOG performance status of 0-1 6. Adequate organ and bone marrow function 7. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment. 8. Must provide signed consent to participate in the study and is willing to comply with study-specific procedures. Exclusion Criteria: 1. Received anticancer therapy, therapy for DTGCT, including investigational therapy, within 2 weeks or 28 days for therapies with half-life longer than 3 days prior to the administration of study drug. 2. Unresolved toxicity (>Grade 1 or baseline) from previous anticancer therapy, excluding alopecia. 3. Known active CNS metastases. 4. History or presence of clinically relevant cardiovascular abnormalities. 5. Systemic arterial or venous thrombotic or embolic events. 6. QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome. 7. Left ventricular ejection fraction (LVEF) <50%. 8. Concurrent treatment with proton-pump inhibitor. 9. Major surgery within 2 weeks of the first dose of study drug. 10. Malabsorption syndrome or other illness that could affect oral absorption. 11. Known human immunodeficiency virus, active hepatitis B, active hepatitis C, or active mycobacterium tuberculosis infection. 12. If female, the patient is pregnant or lactating. 13. Known allergy or hypersensitivity to any component of the study drug. 14. Any other clinically significant comorbidities.