check_circleStudy Completed

Pancreatic Neoplasms

Bayer Identifier:

14905

ClinicalTrials.gov Identifier:

NCT01251640

EudraCT Number:

2010-019588-12

EU CT Number:

Not Available
Combination with gemcitabine in advanced pancreatic cancer

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.

Key Participants Requirements

Sex

Both

Age

18 - 99 Years

  • - 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

  • - 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
January 2011 - August 2013
Phase
Phase 1/Phase 2
Could I Receive a placebo
No
Products
Refametinib (BAY86-9766)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
München, 81377, Germany
Completed
Berlin, 13353, Germany
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
EDEGEM, 2650, Belgium
Completed
Olomouc, 775 20, Czechia
Completed
Bochum, 44892, Germany
Withdrawn
Halle, 06120, Germany
Completed
Marburg, 35033, Germany
Withdrawn
Ulm, 89081, Germany
Completed
Ancona, 60126, Italy
Withdrawn
Genova, 16132, Italy
Completed
Brescia, 25124, Italy
Terminated
London, United Kingdom
Completed
Oslo, 0310, Norway
Completed
Oslo, Norway
Completed
Aurora, 80045, United States
Completed
London, SE1 9RT, United Kingdom
Completed
Brno, 602 00, Czechia
Withdrawn
Cincinnati, 45219-2316, United States
Withdrawn
La Jolla, 92093-1503, United States
Completed
Heilbronn, 74078, Germany
Completed
London, WC1E 6BT, United Kingdom
Completed
Gdansk, 80-952, Poland
Completed
Warszawa, 02-781, Poland
Withdrawn
Marseille Cedex 9, 13273, France
Completed
CLERMONT-FERRAND Cedex 1, 63003, France
Withdrawn
Bordeaux, 33076, France
Completed
Pittsfield, 01201, United States
Completed
BRUXELLES - BRUSSEL, 1090, Belgium
Completed
Bialystok, 15-027, Poland

Primary Outcome

  • Number of Subjects With Dose Limiting Toxicities (DLT): Phase I
    date_rangeTime Frame:
    From randomization up to the first 8 weeks of therapy
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    Safety Issue:
    Yes
  • Tumor Response (Adjudicated Blinded Read Assessment): Phase II
    date_rangeTime Frame:
    From start of treatment until 134 weeks assessed every 8 weeks
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    Safety Issue:
    No

Secondary Outcome

  • Tumor Response: Investigator Assessment: Phase I
    date_rangeTime Frame:
    From start of treatment until 134 weeks assessed every 8 weeks
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    Safety Issue:
    No
  • Disease Control (DC): Phase I
    date_rangeTime Frame:
    From start of treatment until 134 weeks assessed every 8 weeks
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    Safety Issue:
    No
  • Disease Control (DC): Phase II
    date_rangeTime Frame:
    From start of treatment until 134 weeks assessed every 8 weeks
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    Safety Issue:
    No
  • Duration of Response (DOR): Phase I
    date_rangeTime Frame:
    From start of treatment until 134 weeks assessed every 8 weeks
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    Safety Issue:
    No
  • Duration of Response: Phase II
    date_rangeTime Frame:
    From start of treatment until 134 weeks assessed every 8 weeks
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    Safety Issue:
    No
  • Time to Progression (TTP): Phase I
    date_rangeTime Frame:
    From start of treatment until 134 weeks assessed every 8 weeks
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    Safety Issue:
    No
  • Time to Progression (TTP): Phase II
    date_rangeTime Frame:
    From start of treatment until 134 weeks assessed every 8 weeks
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    Safety Issue:
    No
  • Progression-Free Survival (PFS): Phase I
    date_rangeTime Frame:
    From start of treatment until 134 weeks assessed every 8 weeks
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    Safety Issue:
    No
  • Progression-Free Survival (PFS): Phase II
    date_rangeTime Frame:
    From start of treatment until 134 weeks assessed every 8 weeks
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    Safety Issue:
    No
  • Overall Survival (OS): Phase I
    date_rangeTime Frame:
    From start of treatment until 134 weeks assessed every 8 weeks
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    Safety Issue:
    No
  • Overall Survival (OS): Phase II
    date_rangeTime Frame:
    From start of treatment until 134 weeks assessed every 8 weeks
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    Safety Issue:
    No

Trial design

A multi-center, phase I/II study of BAY86-9766 in combination with gemcitabine in patients with locally advanced inoperable or metastatic pancreatic cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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