EUCTR2018-004242-42-BE进行中（未招募）1 期
A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- The washout-period after previous antibody therapy is defined as 4 half-lives after the last dose of the antibody
- •- Pediatric and young adult patients will be enrolled, where the specific age requirement for each indication will be specified in the protocol addenda.
- •- Patients must be >11 kg at the time of study enrollment.
- •- Patients with relapsed, recurrent, or refractory DSRCT.
- •- Patients must be 36 months to =29 years of age at the time of study enrollment.
- •- Patients must:
- •have measurable disease by RECIST 1.1
- •have received at least one prior line of systemic treatment (including neoadjuvant and adjuvant chemotherapy). This prior treatment must include approved therapies for which they are eligible, unless the patient is not a suitable candidate for the approved therapy.
- •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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 a known hypersensitivity to ramucirumab, cyclophosphamide, vinorelbine or any of the excipients of the medicinal products.
- •- Patients who have previously received any exposure to ramucirumab are not eligible.
- •- Patients with CNS involvement are ineligible.
研究者
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