A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 84
- 试验地点
- 29
- 主要终点
- Objective Response Rate (ORR) by Investigator
研究概览
简要总结
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
- •Have failed, refused, or have been deemed ineligible for standard therapy
- •Measurable disease
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70
排除标准
- •Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
- •History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
- •Evidence of active cerebral/meningeal disease
研究组 & 干预措施
Brentuximab vedotin 1.8 mg/kg
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
干预措施: brentuximab vedotin (Drug)
Brentuximab vedotin 2.4 mg/kg
Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion
干预措施: brentuximab vedotin (Drug)
Brentuximab vedotin 1.2 mg/kg
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
干预措施: brentuximab vedotin (Drug)
结局指标
主要结局
Objective Response Rate (ORR) by Investigator
时间窗: Up to approximately 3 years
Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
次要结局
- Adverse Events by Severity, Seriousness, and Relationship to Treatment(Up to approximately 3 years)
- Laboratory Abnormalities >/= Grade 3(Up to approximately 3 years)
- Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)(Up to approximately 3 years)
- Progression-Free Survival by Kaplan-Meier Analysis(Up to approximately 2 years)
- Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)(Up to approximately 3 years)
- Duration of Complete Response by Kaplan-Meier Analysis(Up to approximately 2 years)
- Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)(Up to approximately 3 years)
- Incidence of Anti-therapeutic Antibodies (ATA)(Up to approximately 3 years)
- Duration of Objective Response by Kaplan-Meier Analysis(Up to approximately 2 years)
- Complete Remission (CR) Rate by Investigator(Up to approximately 3 years)
- Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)(Up to approximately 3 years)