Clinical trial · Interventional
Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST)
A Phase 1b/2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The Sponsor decided to discontinue this study due to a corporate restructuring intended to prioritize clinical development of select programs. No patients enrolled in this study and no patients received investigational product.
Summary
Brief summary (as posted)
Multicenter, open-label Phase 1b/2 study of ripretinib in combination with binimetinib in patients with gastrointestinal stromal tumor (GIST). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| binimetinib | Drug | Binimetinib | ALIAS |
| Ripretinib | Drug | Ripretinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Escalation
- description
- Escalation Phase: Increasing doses of ripretinib in combination with increase doses of binimetinib in patients with advanced GIST who have progressed on at least imatinib or are intolerant to imatinib and are ripretinib naïve in repeated 28-day cycles. Participants may remain on treatment until disease progression, unacceptable toxicity, or withdrawal of consent
- interventionNames
- Drug: Ripretinib
- Drug: binimetinib
- type
- EXPERIMENTAL
- label
- Expansion
- description
- Ripretinib in combination with binimetinib at the recommended Phase 2 dose (RP2D) in patients with advanced GIST who have progressed on imatinib or are intolerant to imatinib and are naïve. Participants may remain on treatment until disease progression, unacceptable toxicity, or withdrawal of consent
- interventionNames
- Drug: Ripretinib
- Drug: binimetinib
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patients ≥18 years of age with advanced GIST (unresectable or metastatic).
2. Must have at least progressed on imatinib or have documented intolerance to imatinib.
3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
4. Patients must have a histologic diagnosis of GIST.
5. If a female of childbearing potential, must have a negative pregnancy test.
6. Adequate organ function and bone marrow function
Exclusion Criteria:
1. Received prior anticancer therapy within 14 days or 5× the half-life whichever is longer) prior to the first dose.
2. Ongoing or prior participation in the DCC-2618-03-002 study.
3. Prior therapy with ripretinib.
4. Prior therapy with MEK inhibitor.
5. History of certain ocular disorders.
6. History of clinically significant hepatobiliary disease.
7. Known active central nervous system metastases.
8. History or presence of clinically relevant cardiovascular abnormalities.
9. Systemic arterial or venous thrombotic or embolic events within 6 months of first dose.
10. History of acute or chronic pancreatitis
11. History of chronic inflammatory bowel disease or Crohn's disease requiring intervention within 12 months of first dose.
12. Gastrointestinal abnormalities including but not limited to:
* inability to take oral medication,
* malabsorption syndromesReferences
Publications (0)
Data not yet available