- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03069469
Study of DCC-3014 in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor
A Multicenter Phase 1/2, Open-Label Study of DCC-3014 to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Clinical Team
- Phone Number: 785-830-2100
- Email: Clinicaltrials@deciphera.com
Study Locations
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Melbourne, Australia
- Peter MacCallum Cancer Centre
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Toronto, Canada
- Princess Margaret Cancer Center
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Quebec
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Montréal, Quebec, Canada
- McGill University Health Centre
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Lyon, France
- Centre Leon Berard
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Paris, France
- Gustave Roussy Cancer Campus Grand Paris
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Bologna, Italy
- IRCCS istituto Ortopedico Rizzoli
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Milan, Italy
- Istituto Nazionale dei Tumori
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Milan, Italy
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Rome, Italy
- Regina Elena National Cancer Institute
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Leiden, Netherlands
- Leiden University Medical Center
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Warsaw, Poland
- M. Sklodowska-Curie Memorial Cancer Center
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Barcelona, Spain
- Hospital Universitario Vall d'Hebron
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Madrid, Spain
- Hospital Clinico San Carlos
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Sevilla, Spain
- Hospital Universitario Virgen del Rocío, Sevilla
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London, United Kingdom
- University College Hospital
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California
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Palo Alto, California, United States, 94304
- Stanford Cancer Institute
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Colorado
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Denver, Colorado, United States, 80204
- University of Colorado - Denver
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic
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Miami, Florida, United States, 33136
- University of Miami
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana Farber
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New York
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New York, New York, United States, 10065
- MSKCC
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Portland, Oregon, United States, 97239
- OHSU
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria
Dose Escalation Phase:
- Patients ≥18 years of age
Patients must have:
- advanced malignant solid tumors; or
- symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
- Malignant solid tumor patients only: Able to provide a tumor tissue sample
- Must have 1 measurable lesion according to RECIST Version 1.1
- Malignant solid tumor patients only: Must have ECOG performance status of 0-1
- Adequate organ and bone marrow function
- If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
- Must provide signed consent to participate in the study and is willing to comply with study-specific procedures.
Expansion Phase (Cohorts A and B)
- Patients ≥18 years of age
Patients must have symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
a) Expansion Cohort B: patients must have prior systemic treatment with anti-CSF1 or anti-CSF1R therapy, with the exception of imatinib or nilotinib
- Adequate organ and bone marrow function
- Must have at least 1 measurable lesion according to RECIST Version 1.1
- If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
- Must provide signed consent to participate in the study and is willing to comply with study-specific procedures.
Exclusion Criteria
Dose Escalation Phase:
- Received anticancer therapy or therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with half-life (t1/2) longer than 3 days prior to the administration of study drug.
- Unresolved toxicity (Grade >1 or baseline) from previous anticancer therapy or TGCT therapy, excluding alopecia.
- Known active CNS metastases.
- History or presence of clinically relevant cardiovascular abnormalities.
- Systemic arterial or venous thrombotic or embolic events.
- QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome.
- Left ventricular ejection fraction (LVEF) <50%.
- Concurrent treatment with proton-pump inhibitor(s).
- Major surgery within 2 weeks of the first dose of study drug.
- Malabsorption syndrome or other illness that could affect oral absorption.
- Known human immunodeficiency virus, active hepatitis B, active hepatitis C, or active mycobacterium tuberculosis infection.
- If female, the patient is pregnant or lactating.
- Known allergy or hypersensitivity to any component of the study drug.
- Any other clinically significant comorbidities.
Expansion Phase (Cohorts A and B)
- Expansion Cohort A: received systemic therapy targeting CSF1 or CSF1R; previous therapy with imatinib and nilotinib is allowed.
- Expansion Cohort B: discontinued systemic therapy targeting anti-CSF1 or anti-CSF1R due to drug-induced liver injury.
- Treatment with therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with a t1/2 longer than 3 days prior to the administration of the study drug.
- Known metastatic TGCT or other active cancer that requires concurrent treatment.
- QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome.
- Left ventricular ejection fraction (LVEF) <55%.
- Concurrent treatment with proton-pump inhibitor(s).
- Major surgery within 2 weeks of the first dose of study drug.
- Any clinically significant comorbidities
- Malabsorption syndrome or other illness that could affect oral absorption.
- Known human immunodeficiency virus (HIV), active or chronic hepatitis B, active or chronic hepatitis C, or active mycobacterium tuberculosis infection.
- If female, the patient is pregnant or lactating.
- Known allergy or hypersensitivity to any component of the study drug.
- Contraindication for MRI
- Active liver or biliary disease, including evidence of fatty liver, nonalcoholic steatohepatitis (NASH), or cirrhosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Experimental Treatment
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. |
CSF1R inhibitor
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Maximum tolerated dose
Time Frame: Day 1 - Day 28 of Cycle 1 for each dose level tested
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Identify the dose limiting toxicities for each dose level tested and determine the maximum tolerated dose and recommended Phase 2 dose
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Day 1 - Day 28 of Cycle 1 for each dose level tested
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Incidence of Adverse Events
Time Frame: Cycle 1 through study completion (~ 24 months)
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Identify the observed adverse events, serious adverse events associated with DCC-3014
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Cycle 1 through study completion (~ 24 months)
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Time to maximum observed concentration of DCC-3014
Time Frame: Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose)
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Measure the time to maximum plasma concentration of DCC-3014 in patients
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Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose)
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Maximum observed concentration of DCC-3014
Time Frame: Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose)
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Measure the maximum observed concentration of DCC-3014 in patients
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Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose)
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Trough observed concentration of DCC-3014
Time Frame: Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose)
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Measure the observed trough concentration of DCC-3014 in patients
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Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose)
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Area under the concentration-time curve of DCC-3014
Time Frame: Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose)
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Measure the AUC of DCC-3014
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Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose)
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Half life of DCC-3014
Time Frame: Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose)
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Measure half life of DCC-3014 in patients
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Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose)
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Objective response rate (ORR= complete response [CR]+partial response [PR]) (Expansion Phase only)
Time Frame: At Week 25 (Cycle 7, Day 1)
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Assessed by central read using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
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At Week 25 (Cycle 7, Day 1)
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Duration of response rate (DOR) (Expansion Phase only)
Time Frame: Baseline through 24 months
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Measure time from PR or CR to disease progression or death
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Baseline through 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate (Expansion Phase only)
Time Frame: At Week 25 (Cycle 7, Day 1)
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Assessed by central read using tumor volume score and modified RECIST (mRECIST) Version 1.1
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At Week 25 (Cycle 7, Day 1)
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Range of Motion (ROM) (Expansion Phase only)
Time Frame: Baseline to Week 25 (Cycle 7, Day 1)
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Measure mean change from baseline in relative ROM
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Baseline to Week 25 (Cycle 7, Day 1)
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Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale (NRS) Score (Expansion Phase only)
Time Frame: Baseline to Week 25 (Cycle 7, Day 1)
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Proportion of responders based on Brief Pain Inventory (BPI) worst pain numeric rating scale (NRS) and narcotic analgesic use by Brief Pain Inventory-30 (BPI-30)
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Baseline to Week 25 (Cycle 7, Day 1)
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Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score (Expansion Phase only)
Time Frame: Baseline to Week 25 (Cycle 7, Day 1)
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Analysis of patient reported outcomes based upon the patient-reported outcomes measurement information system (PROMIS) physical function questionnaire
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Baseline to Week 25 (Cycle 7, Day 1)
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Worst Stiffness Numeric Rating Scale (NRS) Score (Expansion Phase only)
Time Frame: Baseline to Week 25 (Cycle 7, Day 1)
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Analysis of patient reported outcomes based upon the Worst Stiffness Numeric Rating Scale (NRS)
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Baseline to Week 25 (Cycle 7, Day 1)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maitreyi Sharma, MD, Deciphera Pharmaceuticals LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCC-3014-01-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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