Trial Condition(s):

Carcinoma, Renal Cell

A Phase II uncontrolled study of BAY73-4506 in previously untreated patients with metastatic or unresectable RCC

Bayer Identifier:

11726

ClinicalTrials.gov Identifier:

NCT00664326

EudraCT Number:

2008-000107-28

Study Completed

Trial Purpose

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).

Inclusion Criteria
- Male or female patients >/= 18 years of age.
 - Patients, who suffer from unresectable and/or metastatic, measurable predominantly clear cell RCC (renal cell carcinoma histologically) or cytologically documented.
 - Patients must be previously untreated for advanced disease. Prior palliative radiation therapy is allowed if the target lesion(s) are not included within the radiation field and no more than 30% of the bone marrow is irradiated.
 - Patients who have at least one uni-dimensional measurable lesion by computed tomography (CT-scan) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST).
 - Patients with “Intermediate” or “Low” risk per the Motzer score.
 - Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1.
 - Adequate bone marrow, renal and hepatic function as assessed by the following laboratory requirements to be conducted within 7 days prior to study drug treatment
Exclusion Criteria
- Patients who have received prior systemic treatment regimens for RCC.
 - Uncontrolled/unstable cardiac disease
 - Uncontrolled hypertension
 - Active clinically serious infections (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2 )
 - History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
 - Known history or symptomatic metastatic brain or meningeal tumours
 - Patients with seizure disorder requiring medication
 - Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >/= CTCAE Grade 3 within 4 weeks of first dose of study.
 - Pregnant or breast-feeding patients

Trial Summary

Enrollment Goal
49
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Frankfurt, Germany, 60596

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 10967

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Completed
 
Locations

Investigative Site

Bristol, United Kingdom, BS2 8ED

Status
Completed
 
Locations

Investigative Site

NANTES, France, 44020

Status
Completed
 
Locations

Investigative Site

Poznan, Poland, 60-569

Status
Completed
 
Locations

Investigative Site

Lublin, Poland, 20-090

Status
Completed
 
Locations

Investigative Site

Bialystok, Poland, 15-027

Status
Completed
 
Locations

Investigative Site

Helsinki, Finland, 00290

Status
Completed
 
Locations

Investigative Site

Turku, Finland, FIN-20521

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 20246

Status
Completed
 
Locations

Investigative Site

Northwood, United Kingdom, HA6 2RN

Status
Completed
 
Locations

Investigative Site

Cambridge, United Kingdom, CB2 0QQ

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, SE1 9RT

Status
Completed
 
Locations

Investigative Site

Leicester, United Kingdom, LE1 5WW

Status
Completed
 
Locations

Investigative Site

Los Angeles, United States, 90033

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77030

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75014

Status
Completed
 

Trial Design