NCT03890731

A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed

A Single Arm, Open-label, Multicenter Phase 2 Study of Regorafenib in Participants Who Have Been Treated in a Previous Bayer-sponsored Regorafenib Study (Monotherapy or Combination Treatment) That Has Reached the Primary Completion Endpoint or the Main Data Analysis, or Has Been Stopped Prematurely.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to enable participants, currently receiving regorafenib in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. Patients participating in this study will be observed to collect information on how safe the drugs are and how this treatment is tolerated.

Detailed description

The primary objectives of the study are a) to allow patients from Bayer-sponsored trials to continue regorafenib treatment after their respective study has been completed, and b) to further assess the safety of regorafenib. Secondary objective is the documentation of drug tolerability.

Conditions

• Solid Cancer

Interventions

Type	Name	Description
DRUG	BAY73-4506 (Regorafenib, Stivarga)	Regorafenib is administered orally as 20 or 40 mg tablets at the dose that each patient received during the last cycle of the feeder trial. The dose may be either 60, 80, 120 or 160 mg once daily for 3 weeks of every 4-week cycle (3 weeks on, 1 week off).

Timeline

• Start date: 2019-04-02
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2019-03-26
• Last updated: 2024-04-02
• Results posted: 2024-04-02

Locations

6 sites across 5 countries: United States, Germany, Italy, Japan, United Kingdom

Regulatory

• FDA-regulated drug study