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A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Neoplasms

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Trial Information

A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer


Inclusion Criteria:



- Male or female patients ≥18 years of age

- Histological or cytologically confirmed locally advanced, inoperable or metastatic
pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery

- Patients must have at least one uni-dimensional measurable lesion by CT or MRI
according to RECIST, Version 1.1

- Resolution of all acute toxic effects of any prior local treatment to Common
Terminology Criteria for Adverse Events (CTCAE) Grade
- Eastern Cooperative Oncology Group performance status (ECOG PS)
- Patient has cardiac function, within normal range, as measured by an echocardiogram

Exclusion Criteria:

- Known history of, or symptomatic metastatic brain or meningeal tumors

- History of cardiac disease

- Active clinically serious infections

- Clinically significant (ie. symptomatic) peripheral vascular disease

- Pregnant or lactating women; women of childbearing potential not employing adequate
contraception

- Use of strong inhibitors or inducers of CYP3A4

- Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic
cancer, or other malignancy

- Previous gemcitabine or 5-fluorouracil (5-FU) given concurrently as radiosensitizers
to radiation therapy in adjuvant intention if given within 6 months from start of
study treatment

- Thrombotic or embolic events such within 6 months prior to start of study treatment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of BAY86-9766 to be investigated in combination with the standard gemcitabine regimen in the subsequent Phase II part of this study

Outcome Time Frame:

6 months after Last Patient First Treatment

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

14905

NCT ID:

NCT01251640

Start Date:

January 2011

Completion Date:

May 2014

Related Keywords:

  • Pancreatic Neoplasms
  • pancreatic cancer,
  • MEK-inhibitor
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location

Fountain Valley, California  92708
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Denver, Colorado  
Boston, Massachusetts