Study of Regorafenib and Sildenafil for Advanced Solid Tumors

Summary

This is a phase 1 study of sildenafil in combination with regorafenib in patients with progressive advanced solid tumors. A modified 3+3 dose escalation design will be conducted for the dose escalation of the treatment combination: additional patients will be enrolled at the MTD until a total of 12 patients have been treated at the MTD.

Timeline

Start

2015-07-01

Primary completion

2019-01-28

Completion

2019-01-28

Publications

• Poklepovic AS, Gordon SW, Kothadia S, McGuire WP, Thacker LR, Deng X, Tombes MB, Shrader E, Hudson D, Bandyopadhyay D, Ryan AA, Kmieciak M, Smith S, Dent P. A phase 1 study of regorafenib and sildenafil in adults with advanced solid tumors. Anticancer Drugs. 2024 Jun 1;35(5):450-458. doi: 10.1097/CAD.0000000000001584. Epub 2024 Mar 8.
• Booth L, Roberts JL, Rais R, Cutler RE Jr, Diala I, Lalani AS, Hancock JF, Poklepovic A, Dent P. Neratinib augments the lethality of [regorafenib + sildenafil]. J Cell Physiol. 2019 Apr;234(4):4874-4887. doi: 10.1002/jcp.27276. Epub 2018 Sep 10.

Drugs

Indications