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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Plasma concentration of BAY86-9766

Outcome Time Frame:

Multiple time points up to 6 day

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

14747

NCT ID:

NCT01764828

Start Date:

February 2013

Completion Date:

June 2014

Related Keywords:

  • Neoplasms
  • Phase I
  • Pharmacokinetics
  • Safety measurements
  • Neoplasms

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