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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 cycle 1 through study completion (~ 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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 through study completion (~ 24 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 through study completion (~ 24 months)
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 of DCC-3014
Duration of response rate (DOR) (Expansion Phase only)
Half life of DCC-3014
+6 moreSecondary 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 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Experimental TreatmentExperimental Treatment1 Intervention
Dose Escalation Phase: Increasing doses of DCC-3014 beginning at 10 mg 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.
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Who is running the clinical trial?
Deciphera Pharmaceuticals LLCLead Sponsor
16 Previous Clinical Trials
2,124 Total Patients Enrolled
Maitreyi Sharma, MDStudy DirectorDeciphera Pharmaceuticals LLC
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 am not pregnant and agree to use birth control during the study.I have a condition that affects how my body absorbs medication taken by mouth.I haven't had major surgery recently before starting the study drug.I have an advanced tumor or TGCT that cannot be removed by surgery.I am 18 years old or older.I have had blood clots in my arteries or veins.I haven't had treatments targeting CSF1/CSF1R, drug-related liver issues, or recent TGCT therapy.I have a solid tumor and can perform all my daily activities without help.I do not have HIV, hepatitis B, hepatitis C, or tuberculosis.I have been treated with anti-CSF1 or anti-CSF1R therapy before, but not with imatinib or nilotinib.I am 18 years old or older.My organs and bone marrow are functioning well.My organs and bone marrow are functioning well.I am currently taking proton-pump inhibitors.I have not had major surgery within the specified timeframe before starting the study drug.I have symptomatic TGCT and cannot undergo surgery for it.I do not have active liver or biliary disease.I can provide a sample of my tumor for the study.I have metastatic TGCT or another cancer needing treatment now.I have active cancer spread to my brain.I do not have conditions affecting how my body absorbs medication.I am not pregnant and agree to use birth control during the study.I am currently taking proton-pump inhibitors.My heart's electrical activity (QTcF) is within normal range and I don't have a history of long QT syndrome.I have significant heart problems.I have side effects from cancer treatment that haven't gone away, except for hair loss.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 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
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