Japanese BAY86-9766 Monotherapy Phase I Study

Bayer

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: BAY86-9766

Study type: Interventional

Funder types: Industry

Identifiers

NCT01179295

15091

Details and patient eligibility

About

This is an uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles in Japanese patients with advanced solid tumors

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese patients, who are at least 18 years of age at the first screening examination/ visit, with advanced or refractory solid tumors not amenable to standard therapy.
• Histological or cytological documentation of non-hematologic, malignant solid tumor, excluding primary brain or spinal tumors, with no current involvement in the central nervous system (CNS)
• At least one measurable lesion or evaluable disease according to response evaluation criteria in solid tumors (RECIST) version 1.1
• Eastern cooperative oncology group performance status (ECOG-PS) of 0 or 1
• Life expectancy of at least 12 weeks

Exclusion criteria

• Use of any anti-cancer therapy including chemotherapy, investigational agents or devices and immunotherapy within 4 weeks of the first dose of study medication
• Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
• Known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C
• Inadequate bone marrow, liver and renal function
• Inability to swallow oral medications or any condition that could affect the absorption of orally administered drugs
• Concomitant treatment with cytochrome P450 isoenzymes CYP3A4 inhibitors/inducers, and CYP2C19 inhibitors/ inducers

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Arm 1

Experimental group

Treatment:

Drug: BAY86-9766

Drug: BAY86-9766

Drug: BAY86-9766

Drug: BAY86-9766

Arm 2

Experimental group

Treatment:

Drug: BAY86-9766

Drug: BAY86-9766

Drug: BAY86-9766

Drug: BAY86-9766

Arm 3

Experimental group

Treatment:

Drug: BAY86-9766

Drug: BAY86-9766

Drug: BAY86-9766

Drug: BAY86-9766

Arm 4

Experimental group

Treatment:

Drug: BAY86-9766

Drug: BAY86-9766

Drug: BAY86-9766

Drug: BAY86-9766