Rexahn Phase 2a combination study of RX-3117, Abraxane advances to second stage
Rexahn Pharmaceuticals advances its ongoing Phase 2a study of RX-3117 in combination with Abraxane in first-line patients with metastatic pancreatic cancer following a recently completed routine Safety Monitoring Committee review. The SMC has confirmed that the combination of RX-3117 and Abraxane is safe and well tolerated and that the two drugs can be given in combination at the highest recommended doses for both agents which is once-daily oral administration of 700 mg RX-3117 five times per week plus once-weekly Abraxane at 125 mg/m2 IV given on a three weeks on/one week off per four-week cycle schedule. The Phase 2a is a two-stage, open label clinical proof-of-concept study designed to evaluate the safety and efficacy of RX-3117 in combination with Abraxane in patients with metastatic pancreatic cancer who have had no prior chemotherapies for metastatic disease. The first stage was designed to determine the optimum doses of RX-3117 and Abraxane to be evaluated in the second stage. Up to 40 patients will be enrolled into the second stage of the study and the primary endpoint is progression free survival.