CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 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.

Search/NCT00664326
NCT00664326Phase 2Completed
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A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable Renal Cell Cancer (RCC)

Bayer·interventional·Posted Apr 22, 2008·Updated Jan 29, 2021

In Brief

A Phase 2 clinical trial evaluating Regorafenib (Stivarga, BAY73-4506) for Carcinoma, Renal Cell. Completed, enrolled 49 participants across 18 sites in 6 countries.

Detailed Summary

This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY73-4506 to evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Renal Cell
CountriesFinland, France, Germany, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 22, 2008
Enrollment StartApr 30, 2008
Primary CompletionMay 31, 2009
Study CompletionApr 2, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.2 years ago

Interventions

Regorafenib (Stivarga, BAY73-4506)drug

Patients will be treated with BAY73-4506 160 mg po qd for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Patients will continue treatment with BAY73-4506 until disease progression, intolerable toxicity, or patient refusal to continue with the study or investigator decision to remove the patient from study.