RECRUITING

A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies

Conditions

GIST Advanced gastrointestinal stromal tumors gastrointestinal stromal tumors ripretinib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Master Protocol for the Multi-Cohort, Phase 1/2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies

Quick Facts

Study Start:2023-09-28

Study Completion:2029-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05957367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male or female ≥18 years of age * Module A: Part 1 and Part 2: * 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 * Must have at least 1 measurable lesion according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) * 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, if able	* 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 * 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

Inclusion Criteria

Exclusion Criteria

* Male or female ≥18 years of age
* Module A: Part 1 and Part 2:
* 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
* Must have at least 1 measurable lesion according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
* 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, if able

* 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
* 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

Contacts and Locations

Study Contact

Clinical Team

CONTACT

785-830-2100

Clinicaltrials@deciphera.com

Principal Investigator

Clinical Team

STUDY_DIRECTOR

Deciphera Pharmaceuticals, LLC

Study Locations (Sites)

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

UCLA Department of Medicine-Hematology/Oncology

Los Angeles, California, 90095

United States

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

United States

START Midwest

Grand Rapids, Michigan, 49546

United States

Washington University School of Medicine - Siteman Cancer Center

Saint Louis, Missouri, 63110

United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016

United States

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, 10065

United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Collaborators and Investigators

Sponsor: Deciphera Pharmaceuticals, LLC

Clinical Team, STUDY_DIRECTOR, Deciphera Pharmaceuticals, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-28

Study Completion Date2029-03

Study Record Updates

Study Start Date2023-09-28

Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

Advanced gastrointestinal stromal tumors
gastrointestinal stromal tumors
ripretinib

Additional Relevant MeSH Terms

GIST