A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •Demographic
- •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
- •Anticoagulation therapy within 28 days of Study Day
- •Major surgery within 28 days of Study Day
- •Other investigational procedures are excluded.
- •Inability to tolerate intravenous administration.
- •Subject is pregnant (eg, positive HCG test) or is breast feeding.
排除标准
- 未提供
研究组 & 干预措施
Exploratory Cohort
If a total of two or more responses (partial and complete) in EFTs/DSRCTs are documented in this or the ongoing phase 1 study (20050118), then the study will allow enrollment of up to 10 additional EFT/DSRCT subjects who have been exposed to prior anti-IGF-1R targeting therapy.
干预措施: AMG 479 (Drug)
Main Cohort
Subjects with relapsed Ewing's Family Tumors (EFTs) and Desmoplastic Small Round Cell Tumors (DSRCTs) who have not received prior anti-IGF-1R therapy will receive AMG 479 at 12mg/kg.
干预措施: AMG 479 (Drug)
结局指标
主要结局
Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST
时间窗: From screening to disease progression
次要结局
- Assess the duration of response(From screening to disease progression)
- Assess the safety and tolerability of AMG 479(From informed consent to the End of Study/Safety Follow-Up Visit)
- Assess the clinical benefit rate(From screening to disease progression)
- Assess the progression free survival and overall survival(From screening to disease progression)