Clinical Trial: QUILT-3.025: A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
Brief Summary: 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.
Detailed Summary:
Sponsor: NantCell, Inc.
Current Primary Outcome: Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST [ Time Frame: From screening to disease progression ]
Original Primary Outcome: Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST
Current Secondary Outcome:
- Assess the safety and tolerability of AMG 479 [ Time Frame: From informed consent to the End of Study/Safety Follow-Up Visit ]
- Assess the duration of response [ Time Frame: From screening to disease progression ]
- Assess the clinical benefit rate [ Time Frame: From screening to disease progression ]
- Assess the progression free survival and overall survival [ Time Frame: From screening to disease progression ]
Original Secondary Outcome:
- Assess the duration of response
- Assess the clinical benefit rate
- Assess the progression free survival and overall survival
- Assess the safety and tolerability of AMG 479
Information By: NantCell, Inc.
Dates:
Date Received: November 21, 2007
Date Started: October 2007
Date Completion:
Last Updated: October 26, 2016
Last Verified: October 2016
