NL-OMON52509撤回2 期
A Randomized, Open-Label Phase 1b/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor. - J1S-MC-JV01
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Eli Lilly
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 64（—）
入选标准
- •- Patients with relapsed, recurrent, or refractory DSRCT.- Patients must be 35
- •months to <=29 years of age at the time of study enrollment.- Patients must have
- •received at least one prior line of systemic treatment, have measurable disease
- •by RECIST 1.1, and must not be eligible for surgical resection at time of
- •enrollment.- Patients who have a Lansky (<16 years of age; Lansky et al.
- •1987) or Karnofsky (>=16 years of age; Karnofsky et al. 1948) performance score
- •of at least 50.- Patient with adequate hematologic, coagulation, liver,
- •cardiac, renal and bladder function, and adequate blood pressure (BP) control
- •as per protocol.able for thi
排除标准
- •- Patients who have had allogeneic bone marrow or solid organ transplant are
- •excluded.- Patients who have active infections requiring therapy.- Patients who
- •have a history of fistula, gastrointestinal (GI) ulcer or perforation, or
- •intra-abdominal abscess within 3 months of study enrolment are not eligible.-
- •Patients with a bowel obstruction, extensive intestinal resection or history or
- •presence of inflammatory enteropathy or other GI pathology as per protocol.-
- •Patients with a history of hepatorenal syndrome.- Patients with evidence of
- •active bleeding or a history of significant (>=Grade 3) bleeding event, deep
- •vein thrombosis requiring medical intervention (including pulmonary embolism),
- •hemoptysis or other signs of pulmonary haemorrhage, or esophageal varices
- •within 3 months of enrollment are not eligible.- Patients with a bleeding
- •diathesis or vasculitis are not eligible.- Patients with a history of central
- •nervous system (CNS) arterial/venous thromboembolic events (VTEs) including
- •transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6
- •months of study enrollment are not eligible.- Patients with myocardial
- •infarction or unstable angina within the prior 6 months.- Patients with
- •significant vascular disease or peripheral vascular disease.- Patients with a
- •history of hypertensive crisis or hypertensive encephalopathy within 6 months
- •of study enrollment are not eligible.- Patients who have non-healing wound,
- •unhealed or incompletely healed fracture, or a compound (open) bone fracture at
- •the time of enrolment are not eligible.- Patients previously treated and
- •progressed on combination cyclophosphamide and vinorelbine regimen. (Patients
- •who received combination as maintenance therapy, without progression, would be
- •eligible.)- Patients with known hypersensitivity to cyclophosphamide or
- •vinorelbine.- Patients who have previously received any exposure to ramucirumab
- •are not eligible.
研究者
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