Trial NCT06630234
A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
- Phase
- Phase 1/2
- Sponsor
- Deciphera Pharmaceuticals, LLC
- Conditions
- Gastrointestinal Stromal Tumor (GIST)
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 1Performance status
* 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 cancerPrior malignancy
* Has known active central nervous system (CNS) metastases or an active primary CNS cancerBrain metastases
* 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
Restrictions found (3)
- Brain metastasesConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG PS 0 or 1
Show in the text - Prior malignancyConditionalexclusionShow in the text
Recruiting in Massachusetts
- Dana Farber Cancer Institute · Boston, Suffolk County