Study Complete
Sponsor ID
20060283
A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
Study Details
Single-arm, open-label study of AMG 479 in up to 35 subjects with Ewing’s Family Tumors (EFTs) and Desmoplastic Small Round Cell Tumors (DSRCTs) who have progressed or recurred after at least one prior chemotherapy regimen. An exploratory cohort of an additional up to 10 subjects with prior exposure to anti-IGF-1R therapy and who have progressed or recurred after at least one prior chemotherapy regimen will also be assessed.
Protocol Summary
Primary Outcome Measures
Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST
Timeframe: From screening to disease progression
Secondary Outcome Measures
Assess the safety and tolerability of AMG 479
Timeframe: From informed consent to the End of Study/Safety Follow-Up Visit
Assess the duration of response
Timeframe: From screening to disease progression
Assess the clinical benefit rate
Timeframe: From screening to disease progression
Assess the progression free survival and overall survival
Timeframe: From screening to disease progression
Study Documents
Study Synopsis
Available Language(s): English
Locations
No locations found.