Study of Regorafenib and Sildenafil for Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 1, 2015

Primary Completion Date

January 28, 2019

Study Completion Date

January 28, 2019

Conditions
Solid Tumor
Interventions
DRUG

Regorafenib

Combination of regorafenib and of sildenafil when given to patients with advanced solid tumors. Regorafenib Administration and Treatment Schedule. Regorafenib will be taken orally once daily for the first 21 days of each 28-day cycle. Regorafenib will not be taken on the last 7 days of each cycle. Patients will be instructed as follows: Take regorafenib once daily with a low fat meal that contains less than 30% fat. Take the regorafenib tablets at about the same time each day. Swallow the tablets whole.

DRUG

Sildenafil Citrate

Combination of regorafenib and of sildenafil when given to patients with advanced solid tumors.Sildenafil Administration and Treatment Schedule. Sildenafil will be taken orally once daily at the same time the regorafenib dose is taken for the first 21 days of each 28-day cycle. Sildenafil will not be taken on the last 7 days of each cycle.

Trial Locations (1)

23298

Virginia Commonwealth University/Massey Cancer Center, Richmond

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Virginia Commonwealth University

OTHER