Status:
COMPLETED
A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC
Lead Sponsor:
Bayer
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
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 cont...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 30 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2019
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00664326
Start Date
April 30 2008
End Date
April 2 2019
Last Update
January 29 2021
Active Locations (18)
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1
Los Angeles, California, United States, 90033
2
Houston, Texas, United States, 77030
3
Helsinki, Finland, 00290
4
Turku, Finland, FIN-20521