Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs)
- Registration Number
- NCT00089960
- Lead Sponsor
- Amgen
- Brief Summary
This study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST.
- Detailed Description
Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen Call Center (866-572-6436) for more information.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm AMG 706 AMG 125 mg daily continuously
- Primary Outcome Measures
Name Time Method Objective response rate as defined using modified RECIST criteria. 48 weeks treatment or until progressive disease, or unacceptable toxicity
- Secondary Outcome Measures
Name Time Method Progression-free survival time from randomization to progressive disease Overall survival time to death Time to progression time from response to progressive disease Time to response time from first treatment to response Patient-reported outcomes quality of life Use of opioid analgesics after minimal 6 months treatment narcotics usage during study Objective response by PET and tumor size/density changes at week 8 response rate at week 8 Objective response by size changes and/or target tumor density changes at week 8 response rate at week 8 Safety Endpoints: Incidence of adverse events (including all, serious, grade 3, grade 4 and treatment related) for duration of study Duration of response time to respone to progression Palliative response amelioration of symptoms Pharmacokinetic Endpoints: 1. The AMG 706 PK parameters (Cmax, t1/2, AUC0-24, C24); 2. To explore the PK/PD relationships during specific study timepoints