JPRN-jRCT2080223953已完成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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 17age old（—）
- 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 (greater-than or equal to 16 years of age) performance score of at least 50.
- •- The participant has adequate hematologic, organ, and coagulation function less-than or equal to 2 weeks (14 days) prior to first dose of study drug:
- •Absolute neutrophil count (ANC) greater-than or equal to 750/mm3
- •Platelets greater-than or equal to 75,000/mm3
- •Hemoglobin greater-than or equal to 8 grams per deciliter (g/dL)
- •Total bilirubin (sum of conjugated + unconjugated) less-than or equal to 1.5 x upper limit of normal (ULN) for age
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less-than or equal to 3.0 x ULN
- •Serum creatinine is based on age/gender
- •Adequate coagulation function as defined by International Normalized Ratio less-than or equal to 1.5 or prothrombin time less-than or equal to 1.5 x ULN, and partial thromboplastin time less-than or equal to 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 olaratumab, or longer for other study drugs according to their label.
- •- 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
- •Stem cell infusion without traumatic brain injury
- •Corticosteroids
排除标准
- •Have received treatment within 21 days of the initial dose of olaratumab 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.
研究者
相似试验
进行中（未招募）
1 期
A Study of Olaratumab Alone and in Combination With Standard Chemotherapy in Children With CancerEUCTR2015-005721-39-Outside-EU/EEAEli Lilly and Company70
进行中（未招募）
1 期
Phase I study of LDK378 in pediatric malignancies with a genetic alteration in ALKmalignancies characterized by genetic abnormalities in anaplastic lymphoma kinase (ALK)EUCTR2012-002074-31-GBovartis Pharma Services AG83
进行中（未招募）
1 期
The first phase of a study in which young patients that have diseases where an enzyme called anaplastic lymphoma kinase (ALK) is changed from it's original form are treated by increasing doses of the drug LDK378 and where all study participants are aware of what treatment the patients are receiving.EUCTR2012-002074-31-NLovartis Pharma Services AG83
进行中（未招募）
1 期
A Phase I, open-label, dose escalation study of LDK378 in pediatric patients with malignancies that have a genetic alteration in anaplastic lymphoma kinase (ALK) - Phase I study of LDK378 in pediatric malignancies with a genetic alteration in ALKmalignancies characterized by genetic abnormalities in anaplastic lymphoma kinase (ALK)EUCTR2012-002074-31-FRovartis Pharma Services AG80
已完成
2 期
A Phase I, open-label, dose escalation study of LDK378 in pediatric patients with malignancies that have a genetic alteration in anaplastic lymphoma kinase (ALK)Alle maliginiteiten met een ALK mutatie.malignancies with ALK-aberrationspediatric cancer10027655NL-OMON46950ovartis6