Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.

Bayer

Status and phase: Completed; Phase 1

Conditions: Tumors

Treatments: Drug: Regorafenib (BAY73-4506)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960258

13172

Details and patient eligibility

About

This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg once daily administered orally as a single agent in Japanese patients with advanced solid tumors.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female Japanese patients >/= 18 years
• Histologically or cytologically confirmed solid tumors
• ECOG-PS 0 - 1
• Adequate bone marrow, liver and renal function

Exclusion criteria

• Uncontrolled hypertension
• Patients with severe renal impairment or on dialysis
• Patients with seizure disorder requiring anticonvulsant medication
• Known or suspected allergy to the investigational agent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Regorafenib (BAY73-4506)