Clinical trial · Interventional
Sorafenib for Imatinib/Sunitinib-failed GIST
A Phase II Study of Sorafenib in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors Who Failed to Imatinib and Sunitinib
- 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)
With discovery of KIT (CD117) mutations and the advent of KIT tyrosine kinase inhibitor imatinib, there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib showed activity as second-line therapy in GIST patients after failure with imatinib. However, virtually all patients will eventually progress or become intolerable after imatinib and sunitinib. In preclinical models, sorafenib inhibits KIT activity and cell growth of imatinib-resistant tumors. The objective of this multi-center, non-randomized phase II study is to evaluate the safety and activity of sorafenib given as third-line therapy for GIST.
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 |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib
- description
- The patients will receive daily oral administration of sorafenib 400 mg twice daily.
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Disease-control rate
- timeFrame
- Six months after registration
Secondary outcomes (1)
- measure
- Response rate
- timeFrame
- Every 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age over 18 years * advanced GIST * failed (progressed and/or intolerable) after prior treatments for GIST * ECOG performance status of 0\~2 * resolution of all toxic effects of prior treatments * no prior radiotherapy within 1 month before registration * measurable lesion as defined by RECIST * adequate marrow, hepatic, renal and cardiac functions * provision of a signed written informed consent Exclusion Criteria: * severe co-morbid illness and/or active infections * pregnant or lactating women * history of other malignancies * active CNS disease not controllable with radiotherapy or corticosteroids * active and uncontrollable bleeding from gastrointestinal tract * prior history of sorafenib use * gastrointestinal obstruction or malabsorption syndrome
References
Publications (1)
- DERIVEDPark SH, Ryu MH, Ryoo BY, Im SA, Kwon HC, Lee SS, Park SR, Kang BY, Kang YK. Sorafenib in patients with metastatic gastrointestinal stromal tumors who failed two or more prior tyrosine kinase inhibitors: a phase II study of Korean gastrointestinal stromal tumors study group. Invest New Drugs. 2012 Dec;30(6):2377-83. doi: 10.1007/s10637-012-9795-9. Epub 2012 Jan 25. PMID 22270258