NL-OMON55480撤回2 期
A Randomized, Open-Label Phase 2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with relapsed, Recurrent, or Refractory Synovial Sarcoma. - J1S-MC-JV02
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
Trial never started
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 64（—）
入选标准
- •- Patients with either relapsed, recurrent, or refractory SS., - Patients must
- •be 36 months to <=29 years of age at the time of study enrolment., - 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 enrolment., - 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 and renal function, and adequate blood pressure
- •(BP) control as per protocol.
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 enrolment 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 enrolment 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 gemcitabine or docetaxel. (Patients who received
- •combination as maintenance therapy, without progression, would be eligible.), -
- •Patients with a known hypersensitivity to gemcitabine, docetaxel or agents
- •formulated with Polysorbate 80., - Patients who have previously received any
- •exposure to ramucirumab are not eligible., - Patients with clinical or
- •radiologic findings consistent with interstitial pneumonia or pulmonary
研究者
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