EUCTR2015-005721-39-Outside-EU/EEA进行中（未招募）1 期
A Phase 1, Open-Label, Dose-Escalation Study of Olaratumab as a Single Agent and in Combination with Doxorubicin, Vincristine/Irinotecan, or High-dose Ifosfamide in Pediatric Patients with Relapsed or Refractory Solid Tumors
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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 participant must have histological or cytological evidence of a diagnosis of solid tumor, excluding lymphomas and melanoma, but including central nervous system (CNS) tumors, that is relapsed or refractory, not be amenable to curative treatment.
- •The participant has the presence of measurable and/or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST Version 1.1). Response Assessment in Neuro-Oncology (RANO) Criteria or Macdonald Criteria should be used for CNS tumors.
- •The participant has a Lansky (<16 years of age) or Karnofsky (=16 years of age) performance score of at least 50.
- •The participant has adequate hematologic, organ, and coagulation function =2 weeks (14 days) prior to first dose of study drug:
- •Absolute neutrophil count (ANC) =750 cubic millimeters (mm³)
- •Platelets =75,000/mm³
- •Hemoglobin =8 grams per deciliter (g/dL)
- •Total bilirubin (sum of conjugated + unconjugated) =1.5 x upper limit of normal (ULN) for age
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3.0 x ULN
- •Serum creatinine is based on age/gender
- •Adequate coagulation function as defined by International Normalized Ratio =1.5 or prothrombin time =1.5 x ULN, and partial thromboplastin time =1.5 x ULN
- •Both female and male participants of child-bearing potential must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of study drug, as appropriate.
- •Participants must have fully recovered from the acute toxic effects of all prior anticancer therapies or must adhere to post-treatment conditions as follows:
- •Myelosuppressive chemotherapy
- •Hematopoietic growth factors
- •Biologic (anti-neoplastic agent)
- •Antibody therapy
- •Radiation
- •Stem cell infusion without traumatic brain injury
- •Corticosteroids
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 70
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Have received treatment within 21 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Participants that have had bone marrow or solid organ transplant are excluded.
- •The participant has an active fungal, bacterial, and/or known severe viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
- •Female participants who are pregnant or breastfeeding are excluded.
- •If the participant is to be enrolled in the doxorubicin combination arm, a left ventricular dysfunction (LVEF < 50%) or shortening fraction of <27% by echocardiogram (either multigated acquisition [MUGA] or echocardiogram [ECHO] are required, not both).
- •Participants that have received prior anthracycline therapy if the participant is to be enrolled in the doxorubicin combination arm.
研究者
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