QUILT-3.025: A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors

Male and female subjects ≥ 16 years of age with a diagnosis of EFT or DSRCT who have relapsed or progressed after at least one prior chemotherapeutic regimen will be eligible for this study.

Before any study-specific procedure, the appropriate written informed consent must be obtained.

Inclusion criteria

Disease Related Subjects with pathological or histological diagnosis of Ewing's Family Tumor or Desmoplastic Small Round Cell Tumor.

• Measurable disease as defined by RECIST.
• Documented failure of at least one prior chemotherapy regimen for their disease.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.

Demographic

• Males or females ≥ 16 years old.
• Signed written informed consent.
• Able to comply with visits and procedures.

Laboratory

• Willing to provide existing and/or newly acquired tumor samples.
• Diabetic Subjects (Type 1 or 2) must have HgbA1c < 8.0% and fasting blood glucose level < 160 mg/dL.

General

• Must be willing and able to use birth control (double barrier protection or abstinence) during and for 6 months after the study
• Prior exposure to another anti-IGF-1R therapy will only be allowed for a limited number of additional subjects (up to 10) in an exploratory cohort

Exclusion criteria

Disease Related

• Known brain metastasis.
• History of bleeding diathesis.
• History of another malignancy.
• History of chronic hepatitis.
• Documented prior history of human immunodeficiency virus.

Laboratory

• Absolute neutrophil count < 1.5 x109/L.
• Platelet count < 100 x 109/L.
• Hemoglobin < 9 g/dL.
• PT > 1.5 x institutional upper limit of normal (IULN) or PTT > 1.0 x IULN.
• Serum creatinine > 1.5 x IULN.
• Aspartate aminotransferase (AST) > 2.5 x IULN or Alanine aminotransferase (ALT) > 2.5 x IULN (> 5.0 x if liver metastases present).
• Total bilirubin > 1.5 IULN (> 3.0 x with documented Gilbert's Syndrome)

Medication

• Antitumor treatment within 21 days of Study Day 1.
• Anticoagulation therapy within 28 days of Study Day 1.
• Major surgery within 28 days of Study Day 1.

General

• Other investigational procedures are excluded.
• Inability to tolerate intravenous administration.
• Subject is pregnant (eg, positive HCG test) or is breast feeding.