Advanced Gastrointestinal Stromal Tumor Clinical Trial
Official title:
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
| Verified date | February 2014 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | December 2012 |
| Est. primary completion date | February 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Amgen | Takeda Bio Development Center, Ltd |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The objective response rate as assessed by modified RECIST | Every 8 weeks | No | |
| Secondary | Duration of response, progression-free survival, time to response, overall survival, PK and safety profile | 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; | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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An Observational Study to Learn More About Treatment With Regorafenib in People With Advanced Gastrointestinal Stromal Tumors in the United States
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| Recruiting |
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Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
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Phase 2 |