Status:
COMPLETED
Japanese BAY86-9766 Monotherapy Phase I Study
Lead Sponsor:
Bayer
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01179295
Start Date
November 19 2010
End Date
April 27 2012
Last Update
June 20 2017
Active Locations (1)
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1
Kashiwa, Chiba, Japan, 277-8577