Sarcoma Clinical Trial
Official title:
A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
Single-arm, open-label study of AMG 479 in up to 35 subjects with Ewing's Family Tumors (EFTs) and Desmoplastic Small Round Cell Tumors (DSRCTs) who have progressed or recurred after at least one prior chemotherapy regimen. An exploratory cohort of an additional up to 10 subjects with prior exposure to anti-IGF-1R therapy and who have progressed or recurred after at least one prior chemotherapy regimen will also be assessed.
Status | Completed |
Enrollment | 38 |
Est. completion date | August 2012 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
NantCell, Inc. |
Tap WD, Demetri G, Barnette P, Desai J, Kavan P, Tozer R, Benedetto PW, Friberg G, Deng H, McCaffery I, Leitch I, Badola S, Chang S, Zhu M, Tolcher A. Phase II study of ganitumab, a fully human anti-type-1 insulin-like growth factor receptor antibody, in patients with metastatic Ewing family tumors or desmoplastic small round cell tumors. J Clin Oncol. 2012 May 20;30(15):1849-56. doi: 10.1200/JCO.2011.37.2359. Epub 2012 Apr 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST | From screening to disease progression | No | |
Secondary | Assess the safety and tolerability of AMG 479 | From informed consent to the End of Study/Safety Follow-Up Visit | Yes | |
Secondary | Assess the duration of response | From screening to disease progression | No | |
Secondary | Assess the clinical benefit rate | From screening to disease progression | No | |
Secondary | Assess the progression free survival and overall survival | From screening to disease progression | No |
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