BAY86-9766 Plus Gemcitabine Phase I Study in Asian

• Status: Completed
• Trial end date: 2015-02-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Gemcitabine

Criteria

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) 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