drugset / Trial / NCT02801097

RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD)

NCT02801097

Phase 1 Terminated 28 enrolled EpicentRx, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a phase 1 open-label trial to evaluate the safety, pharmacodynamics and clinical activity of RRx-001 administered in combination with irinotecan. RRx-001 is associated with resensitization to irinotecan in tumors that are previously refractory. This effect has been attributed to the ability of RRx-001 to restore the expression of aberrantly silenced genes, thus re-establishing pathway functions. However, resensitization may have more than one mechanism, among them Pgp pump inhibition and vascular modulation, leading to improved penetration of standard chemotherapy.

Timeline

Start
2016-08-30
Primary completion
2018-11-22
Completion
2019-12-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule
Subject NIBROZETONE Other / unclassified