Rhabdomyosarcoma Clinical Trial
Official title:
A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered as a Single Agent Every 2 Weeks in Patients With Previously-Treated, Advanced or Metastatic Soft Tissue and Ewing's Sarcoma/PNET
This multicenter study will enroll approximately 185 participants with metastatic or advanced
sarcoma, to assess the effectiveness and safety of IMC-A12 monotherapy for this indication.
Participants will be stratified into five tiers according to diagnosis:
1. Ewing's sarcoma/peripheral neuroectodermal tumor (PNET)
2. rhabdomyosarcoma
3. leiomyosarcoma
4. adipocytic sarcoma
5. synovial sarcoma.
A total of 85 participants will be enrolled initially, 17 in each tier. Participants will
receive single agent IMC-A12 every 2 weeks. A treatment cycle will be defined as 6 weeks,
with radiological evaluation at every cycle.
Safety and response in the initial 17 participants in each tier will be used to determine
whether to extend enrollment to the target total of 37 participants per tier.
The purpose of this study is to determine the progression-free survival (PFS) rate assessed 12 weeks after the initiation of IMC-A12 monotherapy, administered every 2 weeks to participants with previously-treated, advanced or metastatic soft tissue and Ewing's sarcoma/PNET. ;
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