Combination With Gemcitabine in Advanced Pancreatic Cancer
NCT ID: NCT01251640
Last Updated: 2021-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2011-01-01
2013-08-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
BAY86-9766+Gemcitabine
Phase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent)
Interventions
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BAY86-9766+Gemcitabine
Phase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Aurora, Colorado, United States
Pittsfield, Massachusetts, United States
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Edegem, , Belgium
Brno, , Czechia
Olomouc, , Czechia
Clermont-Ferrand, , France
Heilbronn, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Marburg, Hesse, Germany
Bochum, North Rhine-Westphalia, Germany
Berlin, , Germany
Brescia, Lombardy, Italy
Ancona, The Marches, Italy
Oslo, , Norway
Oslo, , Norway
Bialystok, , Poland
Gdansk, , Poland
Warsaw, , Poland
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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2010-019588-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14905
Identifier Type: -
Identifier Source: org_study_id
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