UPCC 10997: SINGLE INTRAVENOUS INFUSION OF RSR 13 ON TUMOR OXYGENATION

UPCC 10997：单次静脉输注 RSR 13 对肿瘤氧合的影响

• 批准号: 6263622
• 负责人: JAMES RUFFER
• 金额: $ 2.51万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263622
• 关键词: clinical research; drug screening /evaluation; human subject; human therapy evaluation; intravenous administration; neoplasm /cancer chemotherapy; oxygen; pharmacokinetics; propionates; respiratory oxygenation; sickling inhibitor

The purpose of this current study is to evaluate the safety, tolerance, tumor oxygenation, PK, and PD of a single IV infusion of RSR13 (or placebo) administered with supplemental low flow oxygen in patients with primary carcinomas or metastases readily amenable to oxygen determination measurements by Eppendorf p02 Histograph. The dose of RSR-13 used in this study will be 100 mg/kg. based on the results from Study RSR-13 HV-001, the expected PD effect of this dose administered over 90 minutes is an increase in p50 of 11.9 mmHg. This dose is expected to be therapeutically relevant, and tumor oxygenation measurements will be taken prior to RSE-13 (or placebo) infusion and again beginning within 30 minutes after end-infusion.

本研究的目的是评估在具有原发性癌或转移的患者中与补充低流量氧气一起施用RSR 13（或安慰剂）的单次IV输注的安全性、耐受性、肿瘤氧合、PK和PD，所述原发性癌或转移易于通过Eppendorf p02 Histograph进行氧测定测量。 本研究中使用的RSR-13剂量为100 mg/kg。 根据研究RSR-13 HV-001的结果，该剂量在90分钟内给药的预期PD效应为p50增加11.9 mmHg。预期该剂量是治疗相关的，并且将在RSE-13（或安慰剂）输注之前进行肿瘤氧合测量，并在输注结束后30分钟内再次开始。