A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
Recruiting
Phase 1
Phase 2
Interventional Study
Gastrointestinal Stromal Tumor (GIST)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- Deciphera Pharmaceuticals, LLC · Industry
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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 Expa…
Trial Locations
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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 …
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