Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

Summary

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.

Official Title

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

Keywords

Gastrointestinal Stromal Tumor (GIST), PDGFRA mutations, KIT mutations, Gastrointestinal Stromal Tumors, DCC-3009, DCC-3009 Module A

Eligibility

You can join if…

Open to people ages 18 years and up

Module A Part 1 (Escalation):

  • 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

You CAN'T join if...

  • 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

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • HonorHealth accepting new patients
    Scottsdale Arizona 85258 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Deciphera Pharmaceuticals, LLC
ID
NCT06630234
Phase
Phase 1/2 Gastrointestinal Stromal Tumor Research Study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated