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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05957367
Other study ID # DCC-3116-01-002
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 28, 2023
Est. completion date June 2027

Study information

Verified date May 2024
Source Deciphera Pharmaceuticals LLC
Contact Clinical Team
Phone 785-830-2100
Email Clinicaltrials@deciphera.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 1/2, multicenter, open-label (unless otherwise specified in a combination-specific module) study of DCC-3116 in combination with anticancer therapies. Modules within the master protocol are defined according to different combinations of DCC-3116 with other anticancer agents.


Recruitment information / eligibility

Status Recruiting
Enrollment 94
Est. completion date June 2027
Est. primary completion date March 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female =18 years of age - Module A: Part 1 and Part 2: Module A Part 1 and Part 2 DCC-3116 combination closed on January 8, 2024, with no participants enrolled. - Module B: Only for Part 1 (Safety/Dose-finding): - Pathologically confirmed diagnosis of GIST with a KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation - Must have progressed on at least one approved systemic regimen given in the locally advanced or metastatic setting or have documented intolerance to it - Must not have received prior ripretinib treatment - Module B: Only for Part 2 (Expansion) - Pathologically confirmed GIST with documented mutation in KIT exon 11 - Must have progressed on imatinib given in the locally advanced or metastatic setting or have been intolerant to imatinib and may not have received additional systemic therapy for GIST - Measurable disease - Must have a life expectancy of more than 3 months and an ECOG performance status of 0-1 - Adequate organ function and bone marrow reserve based on laboratory assessments performed at Screening - Must provide a fresh tumor biopsy and an archival tumor tissue sample, if available - Must agree to provide an on treatment biopsy Exclusion Criteria: - Must not have received the following within the specified time periods prior to the first dose of study drug: 1. Medications, including anticancer therapies, that are known strong or moderate inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including certain herbal medications (eg, St. John's wort): 14 days or 5×the half-life of the medication (whichever is longer) 2. Other anticancer therapies and any investigational therapies with a known safety and PK profile: 14 days or 5×the half-life of the medication (whichever is shorter) 3. Investigational therapies with unknown safety and PK profile: 28 days. If there is enough data on the investigational therapy to assess the risk for drug-drug interactions and late toxicities of prior therapy as low, the Sponsor's Medical Monitor may approve a shorter washout of 14 days 4. Grapefruit or grapefruit juice: 14 days - Have not recovered from all clinically relevant toxicities from prior therapy - New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of study drug - Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal disease - Malabsorption syndrome - Bone disease that requires ongoing treatment or has required treatment within 6 months of signing the informed consent form - Radiation for indications other than bone disease must have been completed 4 weeks prior to first dose of study drug, unless it consisted of limited field palliative radiation, including whole brain radiation, which must have been completed at least 2 weeks prior to first dose of study drug - Major surgery within 4 weeks of the first dose of study drug - Active HIV, Hepatitis B or Hepatitis C infection

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DCC-3116
Oral Tablet Formulation
Ripretinib
Oral Tablet Formulation

Locations

Country Name City State
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States START Midwest Grand Rapids Michigan
United States UCLA Department of Medicine-Hematology/Oncology Los Angeles California
United States Sylvester Comprehensive Cancer Center Miami Florida
United States Laura & Isaac Perlmutter Cancer Center at NYU Langone Health New York New York
United States Memorial Sloan Kettering Cancer Center - Main Campus New York New York
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Oregon Health & Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Deciphera Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events (Escalation Phase) Identify the observed adverse events and serious adverse events associated with DCC-3116 in combination with other anticancer therapies. Approximately 24 months
Primary Recommended Phase 2 Doses (RP2D) (Escalation Phase) Identify the dose-limiting toxicities for each dose level tested and determine the recommended Phase 2 doses of DCC-3116 in combination with other anticancer therapies. Approximately 18 months
Primary Objective response rate (ORR) (Expansion Phase) Proportion of participants who achieve CR or PR per histology-specific consensus response criteria. Approximately 24 months
Secondary Duration of response (DoR) DoR is defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) per histology-specific consensus response criteria until the first date that the progressive disease is objectively documented or death, whichever occurs first. Approximately 24 months
Secondary Disease Control Rate (DCR) The DCR is defined as the proportion of participants who achieve CR, PR, or stable disease (SD) per histology-specific consensus response criteria. Approximately 24 months
Secondary Time to response Time to response is defined as the time from initiation of treatment until the first assessment demonstrating CR or PR per histology-specific consensus response criteria. Approximately 24 months
Secondary Progression-free survival (PFS) PFS is defined as the time from initiation of treatment until documented disease progression per histology-specific consensus response criteria or death, whichever occurs first. Approximately 24 months
Secondary Overall Survival (OS) OS is defined as the time from initiation of treatment until death. Approximately 48 months
Secondary Maximum observed concentration (Cmax) Measure the maximum observed concentration of DCC-3116 combinations. Predose and up to 12 hours postdose
Secondary Time to maximum observed concentration (Tmax) Measure the time to maximum plasma concentration of DCC-3116 combinations. Predose and up to 12 hours postdose
Secondary Minimum observed concentration (Cmin) Measure the minimum observed concentration of DCC-3116 combinations. Predose and up to 12 hours postdose
Secondary Area under the concentration-time curve (AUC) Measure the AUC of DCC-3116 combinations. Predose and up to 12 hours postdose
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