DCC-3014 for Giant Cell Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called vimseltinib (DCC-3014) for individuals with giant cell tumors (TGCT) and other malignant solid tumors. The goal is to determine the optimal dose and assess its effectiveness in treating these tumors. The trial consists of two parts: the first part identifies the right dose, while the second part evaluates its efficacy specifically for TGCT. Suitable candidates have advanced solid tumors or TGCT that cannot be surgically removed and are experiencing symptoms impacting daily life. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial requires that you stop taking any anticancer or TGCT therapy, including investigational therapy, at least 2 weeks before starting the study drug. If the therapy has a longer half-life, you may need to stop 28 days prior. Also, you cannot take proton-pump inhibitors during the trial.
Is there any evidence suggesting that DCC-3014 is likely to be safe for humans?
Research has shown that vimseltinib, the treatment under study, has been tested for safety in people. Studies have found that patients with tenosynovial giant cell tumor (TGCT) generally tolerate vimseltinib well. Some patients experienced side effects, but these were mostly mild to moderate.
In trials, vimseltinib demonstrated a good safety profile compared to a placebo. While some side effects were reported, they were not severe in most cases. Participants should discuss any concerns with their doctors, but evidence suggests that vimseltinib is a promising treatment option with manageable safety issues.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for giant cell tumor, which typically involve surgery or denosumab, DCC-3014 offers a unique approach by targeting the CSF1R pathway. Researchers are excited because this pathway is crucial in the formation and activity of the giant cells that drive the disease. DCC-3014's potential to directly inhibit these processes could lead to more effective control of the tumor's growth and symptoms, offering hope for patients seeking alternatives to invasive or less targeted options.
What evidence suggests that DCC-3014 might be an effective treatment for giant cell tumor?
Research has shown that vimseltinib, also known as DCC-3014, may help treat tenosynovial giant cell tumor (TGCT). Studies have found that this treatment can shrink tumors in patients who cannot undergo surgery. Specifically, a study comparing vimseltinib to a placebo demonstrated significant tumor reduction in those taking vimseltinib. The treatment blocks CSF1R, a receptor involved in tumor growth in TGCT. These findings suggest that vimseltinib could be a useful option for managing TGCT symptoms. Participants in this trial will receive vimseltinib in a dose escalation phase to determine the optimal dose, followed by an expansion phase to further evaluate its effectiveness.13467
Who Is on the Research Team?
Maitreyi Sharma, MD
Principal Investigator
Deciphera Pharmaceuticals, LLC
Are You a Good Fit for This Trial?
Adults with advanced tumors or tenosynovial giant cell tumor (TGCT) that can't be surgically removed may join this trial. They must have measurable lesions, good organ and bone marrow function, and agree to contraception if applicable. Those with certain heart conditions, recent major surgery, active infections like HIV or hepatitis, or who are pregnant/lactating cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive increasing doses of vimseltinib beginning at 10 mg once daily for 28-day cycles until disease progression or unacceptable toxicity
Expansion
Dosing of different patient cohorts at the dose level determined from the Dose Escalation Phase
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DCC-3014
Find a Clinic Near You
Who Is Running the Clinical Trial?
Deciphera Pharmaceuticals, LLC
Lead Sponsor
Deciphera Pharmaceuticals LLC
Lead Sponsor