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

Sponsor ID
20060283
Clinicaltrials.gov ID
NCT00563680
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 2
Product
AMG 479
Type
Interventional
Masking
None (Open Label)
Enrollment
38
Additional Study Details

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.