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

Phase 2
16 Years
Not Enrolling
Askin's Tumors, Desmoplastic Small Round Cell Tumors, Estraosseous Ewing's Tumor, Ewing's Family Tumor, Ewing's Sarcoma, Primitive Neuroectodermal Tumors (PNETs), Sarcoma

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Trial Information

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

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.


- 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

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.


- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST

Outcome Time Frame:

From screening to disease progression

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

October 2007

Completion Date:

August 2012

Related Keywords:

  • Askin's Tumors
  • Desmoplastic Small Round Cell Tumors
  • Estraosseous Ewing's Tumor
  • Ewing's Family Tumor
  • Ewing's Sarcoma
  • Primitive Neuroectodermal Tumors (PNETs)
  • Sarcoma
  • AMG 479
  • IGF-1R
  • Insulin-like growth factor
  • Insulin-like growth factor receptor
  • Ewing's
  • Sarcoma
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Desmoplastic Small Round Cell Tumor
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma