Neoplasms
Conditions
Keywords
MEK inhibitor, BAY86-9766, RDEA 119, Solid tumor
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 patients with advanced solid tumors
Interventions
DRUGBAY86-9766
BAY86-9766 30 mg twice a day (bid).
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation due to results of physical examinations, vital signs, AEs, abnormal laboratory tests and 12-lead ECG, cardiac function test and ophthalmological examination. | At the end of 30-day follow up after discontinuation of study drug administration |
| Calculation of pharmacokinetic parameters of BAY86-9766 and its metabolite (M17). | Cycle 1 Day 22 and Day 23 for Cohorts 1 & 2 and Cohorts 3 & 4, respectively. |
Secondary
| Measure | Time frame |
|---|---|
| Response rate | On average 3 months |
| Disease control rate | On average 3 months |
Countries
Japan
Outcome results
None listed