A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (… (NCT04282980) | Clinical Trial Compass
CompletedPhase 2
A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)
China39 participantsStarted 2020-04-23
Plain-language summary
The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female patients ≥18 years of age.
* Patients with advanced gastrointestinal stromal tumors.
* Subjects who have progressed or documented intolerance after previous treatments.
* Sign informed consent, understand the Protocol and could follow the Protocol.
* The subject had at least one measurable lesion.
* Adequate organ function and bone marrow reserve
Exclusion Criteria:
* Treatment with anticancer therapy, including investigational therapy, or investigational procedures within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of investigational drug.
* Prior treatment with DCC-2618.
* Previously or currently has an additional malignancy that is progressing or required active treatment, which may interfere with the safety or efficacy evaluation of DCC-2618.
* Patient has known active central nervous system metastases.
* New York Heart Association class II - IV heart disease, active ischemia or any other uncontrolled cardiac condition.
* Arterial thrombotic or embolic events within 6 months before the first dose of investigational drug.
* Venous thrombotic events within 3 months before the first dose of investigational drug.
* 12-lead electrocardiogram (ECG) demonstrating QT interval corrected by Fridericia's formula \>450 ms in males or \>470 ms in females at screening or history of long QT interval syndrome.
* Left ventricular ejection fraction (LVEF) \<50% at screening.
* Use of known substrates or inhibitors of br…
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: Approximately 10 months since the first subject enrolled.