CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
BAY73-4506 (Regorafenib, Stivarga)drug
Likely dose
BAY73-4506 (Regorafenib, Stivarga) 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03890731
NCT03890731Phase 2Completed

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.

Bayer·interventional·Posted Mar 26, 2019·Updated Apr 2, 2024

In Brief

A Phase 2 clinical trial evaluating BAY73-4506 (Regorafenib, Stivarga) for Solid Cancer. Completed, enrolled 6 participants across 6 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Cancer
CountriesGermany, Italy, Japan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 26, 2019
Enrollment StartApr 2, 2019
Primary CompletionFeb 28, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 7.3 years ago

Interventions

BAY73-4506 (Regorafenib, Stivarga)drug

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).