Spots Global Cancer Trial Database for Combination With Gemcitabine in Advanced Pancreatic Cancer
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Trial Identification
Brief Title: Combination With Gemcitabine in Advanced Pancreatic Cancer
Official Title: A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer
Study ID: NCT01251640
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Aurora, Colorado, United States
, Pittsfield, Massachusetts, United States
, Bruxelles - Brussel, , Belgium
, Bruxelles - Brussel, , Belgium
, Edegem, , Belgium
, Brno, , Czechia
, Olomouc, , Czechia
, CLERMONT-FERRAND Cedex 1, , France
, Heilbronn, Baden-Württemberg, Germany
, München, Bayern, Germany
, Marburg, Hessen, Germany
, Bochum, Nordrhein-Westfalen, Germany
, Berlin, , Germany
, Brescia, Lombardia, Italy
, Ancona, Marche, Italy
, Oslo, , Norway
, Oslo, , Norway
, Bialystok, , Poland
, Gdansk, , Poland
, Warszawa, , Poland
, London, , United Kingdom
, London, , United Kingdom
, London, , United Kingdom
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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