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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
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

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-time curve (AUC) of Vimseltinib
Duration of response rate (DOR) (Expansion Phase only)
Half life of Vimseltinib
+6 more
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Deciphera Pharmaceuticals LLCLead Sponsor
16 Previous Clinical Trials
2,107 Total Patients Enrolled
Maitreyi Sharma, MDStudy DirectorDeciphera Pharmaceuticals LLC

Media Library

DCC-3014 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03069469 — Phase 1 & 2
Giant Cell Tumor Research Study Groups: Experimental Treatment
Giant Cell Tumor Clinical Trial 2023: DCC-3014 Highlights & Side Effects. Trial Name: NCT03069469 — Phase 1 & 2
DCC-3014 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03069469 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research endeavor still being accepted?

"The clinical trial's introduction and latest update can both be found on the website of clinicaltrials.gov. This research was published in February 2017, with an updated version issued December 2021. The project is currently seeking participants to join its ranks."

Answered by AI

At how many centers is this experiment taking place?

"This medical trial is currently enrolling patients at numerous research centers, such as Stanford Cancer Institute in Palo Alto, California; MSKCC in New york City; and Oregon Health & Science University situated in Portland, Oregon."

Answered by AI

What is the scope of enrollment for this clinical trial?

"This trial requires 120 volunteers who meet the eligibility criteria. Participatory locations include Stanford Cancer Institute in Palo Alto and MSKCC, located in New york City."

Answered by AI

What is the fundamental purpose behind this clinical experiment?

"According to Deciphera Pharmaceuticals LLC., the primary measure of efficacy over a 24-month period is Maximum tolerated dose. Additionally, Response rate (Expansion Phase only) assessed by central read using tumor volume score and modified RECIST (mRECIST) Version 1.1, Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score (Expansion Phase only), and Worst Stiffness Numeric Rating Scale (NRS) Score(Expansion Phase only) are being studied as secondary outcomes."

Answered by AI
~27 spots leftby Jul 2026