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

Completed · Phase 2

Conditions studied: Carcinoma, Renal Cell

In brief

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).

Key facts

Study ID

NCT00664326

Run by

Bayer

People needed

49

Starts

2008-04-30

Expected to finish

2019-04-02

Last updated by the study team

2021-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Houston, Texas, United States
• Study site — Helsinki, Finland
• Study site — Turku, Finland
• Study site — Nantes, France
• Study site — Paris, France
• Study site — Frankfurt am Main, Hesse, Germany
• Study site — Dresden, Saxony, Germany
• Study site — Berlin, Germany
• Study site — Hamburg, Germany
• Study site — Bialystok, Poland
• Study site — Lublin, Poland
• Study site — Poznan, Poland
• Study site — Leicester, Leicestershire, United Kingdom
• Study site — Bristol, United Kingdom
• Study site — Cambridge, United Kingdom
• Study site — London, United Kingdom
• Study site — Northwood, United Kingdom

Full record on ClinicalTrials.gov

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