NCT00664326

A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC

A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable Renal Cell Cancer (RCC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The final analysis of efficacy will be performed after last patient has been treated for at least 6 months. Additional periodic safety and efficacy data reviews will be performed for any patients continuing to receive study drug afterwards.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Regorafenib (Stivarga, BAY73-4506)	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.

Timeline

• Start date: 2008-04-30
• Primary completion: 2009-05-31
• Completion: 2019-04-02
• First posted: 2008-04-22
• Last updated: 2021-01-29
• Results posted: 2012-11-28

Locations

18 sites across 6 countries: United States, Finland, France, Germany, Poland, United Kingdom

Regulatory

• FDA-regulated drug study