Study Complete
Sponsor ID
20120238
A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma
Study Details
Phase 1b/2a, open-label, sequential dose escalation and expansion study of AMG 232 in combination with trametinib and dabrafenib in subjects with metastatic melanoma followed by a direct comparison of AMG 232 combined with trametinib and dabrafenib versus trametinib combined with dabrafenib alone.
Protocol Summary
Primary Outcome Measures
Subject incidence of treatment-emergent adverse events, Results of safety laboratory tests, vital sign measurements, ECG measurements, PK parameters; Progression-free Survival Rate
Timeframe: 36 months
Secondary Outcome Measures
Time to and duration of overall response and duration of stable disease measured by CT or MRI and assessed per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, Progression-free and Overall Survival
Timeframe: 36 months
Locations
Location
Research Site
Boston, MA, United States, 02114
Status
Recruiting
Location
Research Site
Los Angeles, CA, United States, 90095
Status
Completed
Location
Research Site
Melbourne, VIC, Australia, 3000
Status
Completed
Location
Research Site
North Sydney, NSW, Australia, 2060
Status
Completed
Location
Research Site
Chapel Hill, NC, United States, 27599
Status
Recruiting
Location
Research Site
Nashville, TN, United States, 37232
Status
Completed
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