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

• Status: Completed
• Trial end date: 2019-04-02
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

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