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Kinase Inhibitor

DCC-3014 for Giant Cell Tumor

Phase 1 & 2

Waitlist Available

Research Sponsored by Deciphera Pharmaceuticals, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Dose Escalation Phase: Patients must have advanced malignant solid tumors or symptomatic TGCT for which surgical resection is not an option (tumor biopsy required if no histology/pathology available)

Dose Escalation Phase: Malignant solid tumor patients must have ECOG performance status of 0-1

Must not have

Dose Escalation Phase: Known infections or conditions (HIV, hepatitis B, hepatitis C, tuberculosis)

Expansion Phase (Cohorts A and B): Malabsorption syndrome or other illness affecting oral absorption

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date from pr or cr to disease progression or death (estimated up to 24 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug, DCC-3014, in patients with solid tumors or a rare tumor of the tendon called tenosynovial giant cell tumor (TGCT). The trial has two parts: dose escalation (phase 1) and expansion (phase 2). In phase 1, both types of patients will be enrolled. In phase 2, only TGCT patients will be enrolled, in two different cohorts.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects for DCC-3014 aren't listed here, common ones for cancer treatments include fatigue, nausea, diarrhea, liver issues, skin reactions and increased risk of infection. Heart rhythm problems are a concern as those with QT prolongation were excluded.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have a solid tumor and can perform all my daily activities without help.

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I am 18 years old or older.

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I have symptomatic TGCT and cannot undergo surgery for it.

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I can provide a sample of my tumor for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I haven't had major surgery recently before starting the study drug.

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I have had blood clots in my arteries or veins.

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

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I am currently taking proton-pump inhibitors.

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I do not have active liver or biliary disease.

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I have metastatic TGCT or another cancer needing treatment now.

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I have active cancer spread to my brain.

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I do not have conditions affecting how my body absorbs medication.

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I am currently taking proton-pump inhibitors.

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My heart's electrical activity (QTcF) is within normal range and I don't have a history of long QT syndrome.

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I have significant heart problems.

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I have side effects from cancer treatment that haven't gone away, except for hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date from pr or cr to disease progression or death (estimated up to 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date from pr or cr to disease progression or death (estimated up to 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and date from pr or cr to disease progression or death (estimated up to 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the concentration-time curve (AUC) of Vimseltinib

Duration of response rate (DOR) (Expansion Phase only)

Half life of Vimseltinib

+6 more

Secondary study objectives

Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale (NRS) Score (Expansion Phase only)

Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score (Expansion Phase only)

Range of Motion (ROM) (Expansion Phase only)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 19Eligibility criteria met