Mass Balance and Metabolite Profile of TH-302 in Advanced Solid Tumors

Phase 1, open-label trial of evofosfamide in solid tumor (2 arms), sponsored by Merck KGaA. Primary endpoints: Pharmacokinetics profile in plasma: Cmax, Tmax, AUC (0-t), lambda_z, t1/2, AUC (0-infinity), CL, Vss, Vz, MRT for TH-302 and its active metabolite Br-IPM at Day 8 and Pharmacokinetics profile in excreta: Cumulative Ae (0-t), Ae (0-infinity), percent radioactive dose excreted in urine and feces, AeUF, CLR, CLNR for TH-302 and its active metabolite Br-IPM at Day 1. Started Feb 2014; status: completed.