A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDeciphera Pharmaceuticals, LLC
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- DCC-3009
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov