Trial Condition(s):

Pancreatic Neoplasms

Combination with gemcitabine in advanced pancreatic cancer (BAGPAC)

Bayer Identifier:

14905

ClinicalTrials.gov Identifier:

NCT01251640

EudraCT Number:

2010-019588-12

EU CT Number:

Not Available

Study Completed

Trial Purpose

Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.
Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.
Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability.
Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and weekly throughout the study; Safety follow-up visit 30 days after the last dose of study treatment; Survival follow up monthly for up to 8 month after LPFV.

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 </= 1
 - Eastern Cooperative Oncology Group performance status (ECOG PS) </= 2
 - 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

Trial Summary

Enrollment Goal
90
Trial Dates
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Phase
1/2
Could I receive a placebo?
No
Products
Refametinib (BAY86-9766)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

München, Germany, 81377

Status
Completed
Locations

Investigative Site

Berlin, Germany, 13353

Status
Completed
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
Locations

Investigative Site

EDEGEM, Belgium, 2650

Status
Completed
Locations

Investigative Site

Olomouc, Czech Republic, 775 20

Status
Completed
Locations

Investigative Site

Bochum, Germany, 44892

Status
Completed
Locations

Investigative Site

Marburg, Germany, 35033

Status
Completed
Locations

Investigative Site

Ancona, Italy, 60126

Status
Completed
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Investigative Site

Brescia, Italy, 25124

Status
Completed
Locations

Investigative Site

London, United Kingdom

Status
Terminated
Locations

Investigative Site

Oslo, Norway, 0310

Status
Completed
Locations

Investigative Site

Oslo, Norway

Status
Completed
Locations

Investigative Site

Aurora, United States, 80045

Status
Completed
Locations

Investigative Site

London, United Kingdom, SE1 9RT

Status
Completed
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Investigative Site

Brno, Czech Republic, 602 00

Status
Completed
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Investigative Site

Heilbronn, Germany, 74078

Status
Completed
Locations

Investigative Site

London, United Kingdom, WC1E 6BT

Status
Completed
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Investigative Site

Gdansk, Poland, 80-952

Status
Completed
Locations

Investigative Site

Warszawa, Poland, 02-781

Status
Completed
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Investigative Site

CLERMONT-FERRAND Cedex 1, France, 63003

Status
Completed
Locations

Investigative Site

Pittsfield, United States, 01201

Status
Completed
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1090

Status
Completed
Locations

Investigative Site

Bialystok, Poland, 15-027

Status
Completed

Trial Design