A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer

Summary

This two-stage study is designed to compare the safety and activity between RRx-001 against regorafenib followed by irinotecan-based therapies in a parallel comparative study. Patients who are suffering from advanced or metastatic (meaning the disease has spread) colorectal cancer are invited to participate in this study. There will be two groups of patients (Randomized, open label study), one of these will receive RRx-001 and the other one will receive regorafenib. If patients qualify to participate in this study, they will be randomly assigned to the 'interventional arm' where patients will receive the experimental drug, RRx-001, or the 'control arm' where they will receive the current standard-of-care, Regorafenib. Patients have a 66% chance (2 out of 3) of receiving RRx-001 and a 33 % chance (1 out of 3) of receiving regorafenib. On progression in the first part of the study, provided ECOG performance status is adequate, and if clinically appropriate i.e. there are no absolute or relative contraindications in the opinion of the Investigator, all subjects will enter the second part of the study and receive irinotecan plus bevacizumab. Whether patients are given RRx-001 or regorafenib, they will also receive best supportive care, which includes treatments to help manage side effects and symptoms of cancer. This is an open label study, which means patients will know to which of these treatments, RRx-001 or regorafenib, they are assigned.

Timeline

Start

2014-05

Primary completion

2018-04-13

Completion

2020-10-08

Publications

• Background Oronsky B, Scribner C, Aggarwal R, Cabrales P. RRx-001 protects normal tissues but not tumors via Nrf2 induction and Bcl-2 inhibition. J Cancer Res Clin Oncol. 2019 Aug;145(8):2045-2050. doi: 10.1007/s00432-019-02958-4. Epub 2019 Jun 27.
• Background Scicinski J, Fisher G, Carter C, Cho-Phan C, Kunz P, Ning S, Knox S, Oronsky B, Caroen S, Parker C, Fanger G, Reid T. The Development Of RRx-001, A Novel Nitric-Oxide-Mediated Epigenetically Active Anticancer Agent. Redox Biol. 2015 Aug;5:422. doi: 10.1016/j.redox.2015.09.035. Epub 2015 Dec 30.
• Results Reid TR, Abrouk N, Caroen S, Oronsky B, Stirn M, Larson C, Beale K, Knox SJ, Fisher G. ROCKET: Phase II Randomized, Active-controlled, Multicenter Trial to Assess the Safety and Efficacy of RRx-001 + Irinotecan vs. Single-agent Regorafenib in Third/Fourth Line Colorectal Cancer. Clin Colorectal Cancer. 2023 Mar;22(1):92-99. doi: 10.1016/j.clcc.2022.11.003. Epub 2022 Dec 2.
• Results Reid T, Dad S, Korn R, Oronsky B, Knox S, Scicinski J. Two Case Reports of Resensitization to Previous Chemotherapy with the Novel Hypoxia-Activated Hypomethylating Anticancer Agent RRx-001 in Metastatic Colorectal Cancer Patients. Case Rep Oncol. 2014 Jan 24;7(1):79-85. doi: 10.1159/000358382. eCollection 2014 Jan.

Drugs

Indications