Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma

NCT03029481 | Unknown

• 2 other identifiers: 17-000019JCCCID738
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ewing Sarcoma

Interventions

Ganitumab DRUG

The patient will receive ganitumab, 18 mg/kg/dose intravenously every 2 weeks until clinical progression or decision to move to an alternate therapy.

Also known as: AMG 479

Eligibility Criteria

• Age: 48 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis: Confirmed translocation-positive Ewing sarcoma
• Organ Function Requirements:
• Serum creatinine \< 1.4 Adequate liver function
• Total bilitubin \<1.5x upper limit of normal for age
• SGPT (ALT) \< 5x upper limit of normal for age Adequate cardiac function \> 50% by echocardiogram Bone Marrow
• Absolute neutrophil count \> 750
• Platelet count \> 75

You may not qualify if:

• Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained. Lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of protocol therapy. Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of protocol therapy.
• Patients with known pre-existing diabetes mellitus will be excluded from study.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• NantCell, Inc.: collaborator

MeSH Terms

Conditions

Sarcoma, Ewing

Interventions

ganitumab

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Last Updated: March 28, 2019

Record last verified: 2019-03