Trial Condition(s):

Neoplasms

BAY86-9766 plus gemcitabine Phase I study in Asian

Bayer Identifier:

14747

ClinicalTrials.gov Identifier:

NCT01764828

EudraCT Number:

Not Available

Study Completed

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
23
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Refametinib (BAY86-9766)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Kashiwa, Japan, 277-8577

Status
Completed
 
Locations

Investigative Site

shanghai, China, 200032

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 03080

Status
Completed
 

Trial Design