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临床试验/PER-031-03
PER-031-03已完成未知

RANDOMIZED, PHASE II, NON-COMPARATIVE, IRINOTECAN AND CARBOPLATINIAN TEST IN FRONT OF IRINOTECAN IN MINORS BETWEEN 1 AND 21 YEARS OF SOLID REFRACTORY TUMORS.

BRISTOL MYERS SQUIBB PERU S.A.,0 个研究点目标入组 0 人开始时间: 2003年4月28日最近更新:

试验速览

阶段
未知
状态
已完成
发起方

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
0 至 0(—)

入选标准

  • Completion of at least 6 cycles of therapy on BMS clinical protocol CA124-001 or CA124-002 and who continue to derive clinical benefit and are not experiencing intolerable toxicity from the therapy
  • Karnofsky score of at least 50 for subjects > 10 years of age; Lansky play scale of at least 50 for children 10 years of age and younger
  • Recovery to baseline or Grade 1 from toxicities (except alopecia or asthenia) resulting from previous therapies
  • Males and females, ages 1 - 21 years of age at the time of consent into CA124-001 or CA124-002

排除标准

  • A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy
  • Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy, or any other investigational drug while on study
  • Inadequate bone marrow and renal function
  • Concurrent receipt of Dilantin®(phenytoin), phenobarbital, primidone, Tegretol®(carbamazepine), Depacon®, Depakene®, Depakote®, and Deproic®(valproic acid)

研究者

发起方
BRISTOL MYERS SQUIBB PERU S.A.,

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