Trial Condition(s):
Japanese BAY86-9766 monotherapy Phase I study
15091
Not Available
Not Available
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
- 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
- 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
Locations | Status | |
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Locations Investigative Site Kashiwa, Japan, 277-8577 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Phase 1 study of single agent BAY86-9766 in Japanese patients with advanced or refractory solid tumors
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
4