Clinical trial NCT01395017: Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
Official title: Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
Dasatinib
chemotherapy
Locally advanced
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-15
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic documentation of unresectable adenocarcinoma of the pancreas.
* Recovery from toxicity of previous procedures to establish the diagnosis. ECOG PS 0 or 1.
* Adequate organ function.

Exclusion Criteria:

* Evidence of metastatic disease.
* Previous radiotherapy or chemoradiotherapy.
* History of or current pleural effusion.
* History of significant cardiovascular disease.
* Clinically significant bleeding disorder or coagulopathy.
* Concomitant medication with strong CYP 3A4 inhibitor.

Primary outcomes:
measure: Overall Survival
timeFrame: From randomization until date of death from any cause by 02 December 2013
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Time from randomization to earliest PFS event by 02 December 2013
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Wichita
country: United States
state: Kansas
city: Minneapolis
country: United States
state: Minnesota
city: Albuquerque
country: United States
state: New Mexico
city: Bethlehem
country: United States
state: Pennsylvania
city: Blacktown
country: Australia
state: New South Wales
city: Liverpool
country: Australia
state: New South Wales
city: Tweed Heads
country: Australia
state: New South Wales
city: Footscray
country: Australia
state: Victoria
city: Frankston
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Wien
country: Austria
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Olomouc
country: Czech Republic
city: Pardubice
country: Czech Republic
city: Prague 8
country: Czech Republic
city: Zlin
country: Czech Republic
city: Clermont Ferrand cedex 1
country: France
state: Auvergne
city: Paris
country: France
state: Cedex 14
city: Saint-Priest-en-Jarez
country: France
state: Loire
city: Angers
country: France
state: Maine-et-Loire
city: Besançon cedex
country: France
city: Clichy
country: France
city: Lille
country: France
city: Lyon cedex 03
country: France
city: Saint-Priest-en-Jarez cedex 2
country: France
city: Tübingen
country: Germany
state: Baden-Württemberg
city: Hamburg
country: Germany
city: Köln
country: Germany
city: München
country: Germany
city: Pecs
country: Hungary
state: Baranya
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Dublin 24
country: Ireland
city: Dublin 4
country: Ireland
city: Dublin 7
country: Ireland
city: Dublin 9
country: Ireland
city: Milan
country: Italy
state: MI
city: Udine
country: Italy
state: UD
city: Ancona
country: Italy
city: Reggio Emilia
country: Italy
city: Jelenia Gora
country: Poland
city: Lublin
country: Poland
city: Olsztyn
country: Poland
city: Craiova
country: Romania
state: Dolj
city: Bucharest
country: Romania
city: Cluj-Napoca
country: Romania
city: Kazan
country: Russian Federation
state: Tatarstan Republic
city: Chelyabinsk
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Hull
country: United Kingdom
state: East Yorks
city: Chelmsford
country: United Kingdom
state: Essex
city: Maidstone
country: United Kingdom
state: Kent
city: Northwood
country: United Kingdom
state: Middlesex
city: Sutton
country: United Kingdom
state: Surrey
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Edinburgh
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Salisbury
country: United Kingdom
city: Wirral
country: United Kingdom
Study officials:
References: