At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Regorafenib (Stivarga, BAY73-4506)drug
Likely dose
Regorafenib (Stivarga, BAY73-4506) 160 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.
A Phase I, Multi-center, Non-randomized, Open Label, Parallel-group Study Evaluating the Pharmacokinetics and Safety of Regorafenib (BAY73-4506) in Cancer Subjects With Severe Renal Impairment Compared to a Control Group
In Brief
A Phase 1 clinical trial evaluating Regorafenib (Stivarga, BAY73-4506) for Neoplasms. Completed, enrolled 24 participants across 9 sites in 2 countries.
Detailed Summary
To characterize the pharmacokinetics and safety of regorafenib in cancer subjects with severe renal impairment when compared to the Control group (cancer subjects with normal or mildly impaired renal function)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesCanada, United States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartJun 2013
Primary CompletionJul 2015
Study CompletionNov 2015
TodayJul 2026
First PostedMay 14, 2013
Enrollment StartJun 1, 2013
Primary CompletionJul 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.1 years ago
Interventions
Regorafenib (Stivarga, BAY73-4506)drug
Regorafenib 160 mg o.d. will be administered as a single dose on Day 1 of Stage 1 followed by multiple dosing in an intermittent administration schedule (3 week-on/1 week-off) over 2 cycles in Stage 2 (56 days, cycle defined as 28 days)