EUCTR2018-004243-23-NL进行中（未招募）1 期
A Randomized, Open-Label Phase I/II Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with relapsed, Recurrent, or Refractory Synovial Sarcoma.
适应症
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
- •- Patients with either relapsed, recurrent, or refractory SS.
- •- Patients must be >11 kg at the time of study enrollment.
- •- The patient has 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.
- •- Patients must be 36 months to =29 years of age at the time of study enrolment.
- •- Patients must
- •have measurable disease by RECIST 1.1
- •have received at least one prior line of systemic treatment (including neoadjuvant and adjuvant chemotherapy) that contains ifosfamide and/or doxorubicin, and any 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 must not have received prior exposure to ramucirumab.
- •- Patient with adequate laboratory values and 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: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •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 a known hypersensitivity to ramucirumab , gemcitabine,
- •docetaxel or agents formulated with Polysorbate 80.
- •- 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 who have previously received any exposure to ramucirumab are not eligible.
- •- Patients with clinical or radiologic findings consistent with interstitial pneumonia or pulmonary fibrosis.
- •- Patients with CNS involvement are ineligible.
研究者
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