Clinical trial · Interventional
Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors
An Open-label Phase 2 Study of AMG 706 in Japanese Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate
NCT00254267CI-TRIAL-00013890completedPhase 2ClinicalTrials.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 purpose of the study is to evaluate the safety and efficacy of AMG 706 in patients with gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.
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 |
|---|---|---|---|
| Advanced Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 706 | Drug | Motesanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm One
- description
- AMG 706 125mg, oral, once a day
- interventionNames
- Drug: AMG 706
Primary outcomes (1)
- measure
- The objective response rate as assessed by modified RECIST
- timeFrame
- Every 8 weeks
Secondary outcomes (1)
- measure
- Duration of response, progression-free survival, time to response, overall survival, PK and safety profile
- timeFrame
- imaging, every 8 weeks; survival, every 6 months; PK, Days 1,15, 29, 43, 57, every 2 weeks in week 9 to 16, and every 4 weeks thereafter;
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of histological confirmed GIST * Had prior imatinib mesylate therapy * Has at least 1 measurable leasion by modified RECIST Exclusion Criteria: * Central nervous system tumor involvement requiring treatment * History of myocardial infraction * Uncontrolled hypertension
References
Publications (1)
- DERIVEDBenjamin RS, Schoffski P, Hartmann JT, Van Oosterom A, Bui BN, Duyster J, Schuetze S, Blay JY, Reichardt P, Rosen LS, Skubitz K, McCoy S, Sun YN, Stepan DE, Baker L. Efficacy and safety of motesanib, an oral inhibitor of VEGF, PDGF, and Kit receptors, in patients with imatinib-resistant gastrointestinal stromal tumors. Cancer Chemother Pharmacol. 2011 Jul;68(1):69-77. doi: 10.1007/s00280-010-1431-9. Epub 2010 Sep 14. PMID 20838998