Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects

Phase 1 Completed 26 enrolled EpicentRx, Inc.

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and pharmacokinetic profile of RRx-001 for injection in subjects with advanced solid tumors or lymphomas for which there are no currently accepted curative therapies. This study will also conduct an exploratory evaluation of objective tumor response using CT or MRI.

Timeline

Start: 2011-09
Primary completion: 2015-02
Completion: 2015-02

Publications

Reid T, Oronsky B, Scicinski J, Scribner CL, Knox SJ, Ning S, Peehl DM, Korn R, Stirn M, Carter CA, Oronsky A, Taylor MJ, Fitch WL, Cabrales P, Kim MM, Burris HA Rd, Lao CD, Abrouk NED, Fanger GR, Infante JR. Safety and activity of RRx-001 in patients with advanced cancer: a first-in-human, open-label, dose-escalation phase 1 study. Lancet Oncol. 2015 Sep;16(9):1133-1142. doi: 10.1016/S1470-2045(15)00089-3. Epub 2015 Aug 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NIBROZETONE	Other / unclassified	10 mg/m2	Intravenous
Subject	NIBROZETONE	Other / unclassified	16.7 mg/m2	Intravenous
Subject	NIBROZETONE	Other / unclassified	24.6 mg/m2	Intravenous
Subject	NIBROZETONE	Other / unclassified	33 mg/m2	Intravenous
Subject	NIBROZETONE	Other / unclassified	55 mg/m2	Intravenous
Subject	NIBROZETONE	Other / unclassified	83 mg/m2	Intravenous

Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects

Summary

Timeline

Publications

Drugs

Indications