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

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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.