BAY86-9766 Plus Gemcitabine Phase I Study in Asian

Bayer

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: Gemcitabine; Drug: Refametinib (BAY86-9766)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01764828

14747

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Refametinib (BAY86-9766)+ Gemcitabine

Experimental group

Description:

Single dose of BAY86-9766 on Cycle 1 Day -17; twice daily dosing every day starting on day -14, start dose 50mg bid ( 30mg or 20mg are possible based on adverse events need) in addition with Gemcitabine intravenous on day 1,8 and 15 1000mg/m2

Treatment:

Drug: Gemcitabine

Drug: Refametinib (BAY86-9766)