DCC-3014 for Giant Cell Tumor

Recruiting in Palo Alto (17 mi)

+23 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Deciphera Pharmaceuticals, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a multicenter, open-label Phase 1/2 study of vimseltinib in patients with malignant solid tumors and tenosynovial giant cell tumor (TGCT). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2). Phase 1 will enroll both malignant solid tumor and TGCT patients. Phase 2 will comprise two cohorts (Cohort A and Cohort B) and will only enroll TGCT patients.

Research Team

Maitreyi Sharma, MD

Principal Investigator

Deciphera Pharmaceuticals, LLC

Eligibility Criteria

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

I am not pregnant and agree to use birth control during the study.

I have an advanced tumor or TGCT that cannot be removed by surgery.

I am 18 years old or older.

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Exclusion Criteria

I have received cancer treatment, including trials, within the specified time before starting the study drug.

I do not have HIV, hepatitis B, hepatitis C, or tuberculosis.

I have a condition that affects how my body absorbs medication taken by mouth.

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Treatment Details

Interventions

DCC-3014 (Kinase Inhibitor)

Trial OverviewThe study is testing DCC-3014 in two phases: Phase 1 (Dose Escalation) includes patients with malignant solid tumors and TGCT; Phase 2 (Expansion) has two cohorts of only TGCT patients. The goal is to find the right dose and see how well it works against these tumors.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Experimental TreatmentExperimental Treatment1 Intervention

Dose Escalation Phase: Increasing doses of vimseltinib beginning at 10 milligram (mg) once daily (QD) for 28 day cycles until disease progression or unacceptable toxicity. Expansion Phase: Dosing of different patient cohorts at the dose level determined from the Dose Escalation Phase of the study.