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
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.
- Males or females ≥ 16 years old.
- Signed written informed consent.
- Able to comply with visits and procedures.
- 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.
- 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
- Known brain metastasis.
- History of bleeding diathesis.
- History of another malignancy.
- History of chronic hepatitis.
- Documented prior history of human immunodeficiency virus.
- 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)
- 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.
- Other investigational procedures are excluded.
- Inability to tolerate intravenous administration.
- Subject is pregnant (eg, positive HCG test) or is breast feeding.