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

Bayer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Regorafenib (Stivarga, BAY73-4506)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00664326

11726

2008-000107-28 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Regorafenib (Stivarga, BAY73-4506)

Experimental group

Description:

Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle

Treatment:

Drug: Regorafenib (Stivarga, BAY73-4506)