Clinical trial · Interventional
A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)
A Multicenter Phase 2, Single-Arm Open-Label Study of DCC-2618 to Assess Efficacy, Safety, and Pharmacokinetics In Patients With Advanced Gastrointestinal Stromal Tumors Who Have Progressed On Prior Anticancer Therapies.
NCT04282980CI-TRIAL-00086689completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCC-2618 | Drug | Ripretinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DCC-2618
- description
- DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle.
- interventionNames
- Drug: DCC-2618
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Approximately 10 months since the first subject enrolled.
- description
- Progression-Free Survival (PFS) is defined as the time from the first dose of study drug to the first occurrence of disease progression based on independent radiology review or death due to any cause (whichever occurred first).
Secondary outcomes (4)
- measure
- Objective Response Rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 breast cancer resistance protein (BCRP) transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of investigational drug. * Major surgeries within 4 weeks of the first dose of investigational drug. * Any other clinically significant comorbidities, which in the judgment of the investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks. * Active viral infections. * If female, the patient is pregnant or lactating, or plans to become pregnant during the study treatment period. * Known allergy or hypersensitivity to any component of the investigational drug. * Gastrointestinal abnormalities. * Any active hemorrhages, excluding hemorrhoids or gum bleeding.
References
Publications (0)
Data not yet available
No reference posted for this study.