Trial Condition(s):
Neoplasms
BAY86-9766 plus gemcitabine Phase I study in Asian
Bayer Identifier:
14747
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This is an open-label, uncontrolled, Phase Ib study designed to evaluate the safety, tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood samples for PK (pharmacokinetics) analyses will be collected after a single dose of BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine and BAY86-9766.
Safety evaluation will include adverse events assessment, vital signs, laboratory tests, 12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination at various time points during the study.
Inclusion Criteria
- Male or female patients >/= 18 years of age, with histologically or cytologically documented advanced or refractory solid tumors not amenable to standard therapy - Patients must have at least one measurable or evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - Patients must have a life expectancy of at least 12 weeks, and an Eastern Cooperative Oncology Group Performance Status (ECOG PS) </=1.
Exclusion Criteria
- History of cardiac disease - Active clinically serious infections > Common Terminology Criteria for Adverse Events (CTCAE) grade 2 - Known human immunodeficiency virus (HIV) infection - Uncontrolled seizure disorder - Undergoing renal dialysis - Known bleeding diathesis - History of organ allograft - Pregnant or breast feeding women
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Kashiwa, Japan, 277-8577 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site shanghai, China, 200032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 03080 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A multi-center, Phase Ib study of MEK (Mitogen activated protein kinase/ERK Kinase) inhibitor BAY86-9766 plus gemcitabine in Asian patients with advanced or refractory solid tumors
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Plasma concentration of BAY86-9766Timeframe: Multiple time points up to 6 day
- Plasma concentration of M17 and M11Timeframe: Multiple time points up to 6 day
- Plasma concentration of GemcitabineTimeframe: Multiple time points up to 6 day
- Plasma concentration of dFdUTimeframe: Multiple time points up to 6 day
- Number of adverse events, or abnormal parameters as a measure of safety and tolerabilityParameters are laboratory parameters, vital signs, ECG parameters, cardiac function, and parameters of ophthalmologic examinationsTimeframe: Up to 1 year
Secondary Outcome
- Efficacy of BAY86-9766 shown by a discrete scaleElements of the scale are :Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)Timeframe: Up to 1 year
Additional Information
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