Evaluating DCC-3009 for treating gastrointestinal stromal tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 master protocol study aims to assess the safety, tolerability, and effectiveness of DCC-3009 in patients with gastrointestinal stromal tumors (GIST). The study employs a modular approach, where each module focuses on DCC-3009 alone or in combination with other anticancer therapies. Participants will undergo treatment in 28-day cycles, with the study lasting up to two years. The trial includes dose escalation and expansion phases to determine the optimal dosing regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* 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

Where it's running

• HonorHealth
  Scottsdate, Arizona, United States Recruiting
• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting
• University of Miami - Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Clinical Team
• Email: clinicaltrials@deciphera.com
• Phone: 888-724-3274

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• International registry for very rare childhood tumors

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• Combining ziftomenib and imatinib for advanced gastrointestinal stromal tumors

  This study is testing whether combining two medications, ziftomenib and imatinib, can help adults with advanced gastrointestinal stromal tumors who haven't responded well to imatinib alone.

  Recruiting at 32 sites Phase 1 Kura Oncology, Inc. · Birmingham, Alabama and 31 other locations · NCT06655246

• Collecting tumor tissue from patients with gastrointestinal stromal tumors for research

  This study is collecting tumor samples from people with gastrointestinal stromal tumors to help researchers learn more about the disease and how to treat it better.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT04557969

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.