drugset / Trial / NCT02801097
RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | — | — |
| Subject | NIBROZETONE | Other / unclassified | — | — |