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

本研究的目的是评估原发性癌或转移癌患者单次静脉输注RSR13（或安慰剂）并补充低流量氧的安全性、耐受性、肿瘤氧合、PK和PD，这些患者易于通过Eppendorf p02直方图进行氧测定。本研究使用的RSR-13剂量为100mg /kg。根据RSR-13 HV-001研究的结果，该剂量超过90分钟的预期PD效应是p50增加11.9 mmHg。该剂量预计与治疗相关，肿瘤氧合测量将在RSE-13（或安慰剂）输注前进行，并在输注结束后30分钟内再次开始。

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.