Solid Tumor Clinical Trial
Official title:
Phase I Study of Regorafenib and Sildenafil for Advanced Solid Tumors
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.
This study is a single-arm, open-label, phase 1 trial to determine the RP2D of the
combination of regorafenib and sildenafil. Both study medications will be taken orally on
days 1-21 of each 28-day cycle.
Using a modified 3+3 dose escalation design, 3-6 patients with an advanced solid tumor will
be enrolled at each dose level. Additional patients will be enrolled at the MTD until a total
of 12 patients have been treated at the MTD.
Eligible patients will have received available standard treatments. Patients with solid
tumors for which regorafenib would be considered a standard treatment are eligible as long as
regorafenib has not been previously administered.
Blood samples will be collected for correlative studies including PK, PD, and CTCs. Tumor
samples archived from a previous biopsy or surgery will also be collected for correlative
studies.
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