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临床试验/EUCTR2018-004242-42-IT
EUCTR2018-004242-42-IT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. - J1S-MC-JV01

ELI LILLY & COMPANY, LILLY CORPORATE CENTER0 个研究点目标入组 34 人开始时间: 2021年6月18日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
34
研究概览入排标准研究者记录与标识符相似试验

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
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •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 known hypersensitivity to ramucirumab, cyclophosphamide or vinorelbine.
  • •- Patients who have previously received any exposure to ramucirumab are not eligible.
  • •-Patients with CNS involvement are ineligible.

研究者

发起方
ELI LILLY & COMPANY, LILLY CORPORATE CENTER

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