A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)

Description

The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.

Conditions

Gastrointestinal Stromal Tumor (GIST)

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Study Overview

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Study Details

Study overview

The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.

A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3009 in Participants with Gastrointestinal Stromal Tumor (GIST)

A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)

Condition
Gastrointestinal Stromal Tumor (GIST)
Intervention / Treatment

-

Contacts and Locations

Grand Rapids

START Midwest, Grand Rapids, Michigan, United States, 49546

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Any participant with histologically or cytologically confirmed advanced/unresectable or metastatic GIST with documented KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation, who has progressed on or was intolerant to at least 1 approved tyrosine kinase inhibitor (TKI) regimen in the advanced/metastatic setting
  • * Have at least 1 measurable lesion as defined by mRECIST, v1.1
  • * Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
  • * Adequate organ function, bone marrow function, and electrolytes
  • * All participants agree to comply with the contraception requirements
  • * Have a life expectancy of more than 3 months
  • * Received systemic anticancer therapy or radiotherapy within 14 days prior to first dose of study drug
  • * Prior or concurrent malignancy that requires treatment or is expected to require treatment for active cancer
  • * Has known active central nervous system (CNS) metastases or an active primary CNS cancer
  • * History or presence of clinically relevant cardiovascular abnormalities
  • * Major surgery within 28 days of the first dose of study drug
  • * Had systemic arterial thrombotic or embolic events within 6 months prior to the first dose of study drug
  • * Had venous thrombotic events (e.g., deep vein thrombosis) or venous thrombotic embolic events (e.g., pulmonary embolism) within 1 month prior to the first dose of study drug
  • * Known allergy or hypersensitivity to any component of the study drug
  • * Malabsorption syndrome or other illness that could affect oral absorption
  • * Any other clinically significant comorbidities

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Deciphera Pharmaceuticals, LLC,

Clinical Team, STUDY_DIRECTOR, Deciphera Pharmaceuticals, LLC

Study Record Dates

2028-05