Clinical Trial: Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma
Study Status: Available
Recruit Status: Available
Study Type: Expanded Access: Available for Individual Patients, Treatment IND/Protocol
Official Title: Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma
Brief Summary:
Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy options. A large body of preclinical data supports a role for IGF-1R inhibition in the treatment of Ewing sarcoma.
More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single- agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded access IND to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy.
Detailed Summary:
Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy options. A large body of preclinical data supports a role for IGF-1R inhibition in the treatment of Ewing sarcoma.
More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single- agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded access IND to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy.
Sponsor: Jonsson Comprehensive Cancer Center
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Jonsson Comprehensive Cancer Center
Dates:
Date Received: January 20, 2017
Date Started:
Date Completion:
Last Updated: January 23, 2017
Last Verified: January 2017
