Trial Condition(s):

Neoplasms

Japanese BAY86-9766 monotherapy Phase I study

Bayer Identifier:

15091

ClinicalTrials.gov Identifier:

NCT01179295

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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 Summary

Enrollment Goal
12
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Refametinib (BAY86-9766)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kashiwa, Japan, 277-8577

Status
Completed
 

Trial Design