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

Launched by DECIPHERA PHARMACEUTICALS, LLC · Oct 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called DCC-3009 for patients with a specific type of cancer known as gastrointestinal stromal tumor (GIST). The main goal is to find out if DCC-3009 is safe and effective, both on its own and when combined with other cancer treatments. The study will take place in two parts: first, researchers will gradually increase the dose to find the right level that works best (this is called Dose Escalation), and then they will expand the study to treat more patients at that dose (Dose Expansion). If you join this study, you will receive treatment for up to two years, with each treatment cycle lasting 28 days.

To be eligible for this trial, participants must be adults aged 65 or older, have a confirmed diagnosis of advanced GIST that has not responded to at least one other treatment, and have at least one measurable tumor. They should also be in relatively good health, meaning they can perform daily activities without much difficulty. However, there are some exclusions, such as having other active cancers, recent major surgeries, or certain heart conditions. If you are considering participating, you will receive detailed information about the study and what to expect during your time in the trial.

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Eligibility criteria

• 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