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Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer (LAPC)

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
dasatinib
Placebo
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic cancer, Dasatinib, chemotherapy, Locally advanced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

One arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle) plus dasatinib 100 mg by mouth once daily (QD).

The other arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle) plus matched placebo by mouth once daily (QD).

Outcomes

Primary Outcome Measures

Overall Survival
Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.

Secondary Outcome Measures

Progression Free Survival (PFS)
PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks.

Full Information

First Posted
July 8, 2011
Last Updated
March 10, 2016
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01395017
Brief Title
Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
Acronym
LAPC
Official Title
Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic cancer, Dasatinib, chemotherapy, Locally advanced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
One arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle) plus dasatinib 100 mg by mouth once daily (QD).
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
The other arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle) plus matched placebo by mouth once daily (QD).
Intervention Type
Drug
Intervention Name(s)
dasatinib
Other Intervention Name(s)
BMS-354825
Intervention Description
GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg (or matched placebo) by mouth once daily (QD). Subjects will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.
Time Frame
From randomization until date of death from any cause by 02 December 2013
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks.
Time Frame
Time from randomization to earliest PFS event by 02 December 2013

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
City
Pardubice
ZIP/Postal Code
532 03
Country
Czech Republic
City
Prague 8
ZIP/Postal Code
180 81
Country
Czech Republic
City
Zlin
ZIP/Postal Code
76275
Country
Czech Republic
City
Clermont Ferrand cedex 1
State/Province
Auvergne
ZIP/Postal Code
63003
Country
France
City
Paris
State/Province
Cedex 14
ZIP/Postal Code
75674
Country
France
City
Saint-Priest-en-Jarez
State/Province
Loire
ZIP/Postal Code
42271
Country
France
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49933
Country
France
City
Besançon cedex
ZIP/Postal Code
25030
Country
France
City
Clichy
ZIP/Postal Code
92110
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Lyon cedex 03
ZIP/Postal Code
69437
Country
France
City
Saint-Priest-en-Jarez cedex 2
ZIP/Postal Code
42277
Country
France
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
City
Köln
ZIP/Postal Code
50937
Country
Germany
City
München
ZIP/Postal Code
81925
Country
Germany
City
Pecs
State/Province
Baranya
ZIP/Postal Code
7624
Country
Hungary
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Dublin 24
Country
Ireland
City
Dublin 4
Country
Ireland
City
Dublin 7
Country
Ireland
City
Dublin 9
Country
Ireland
City
Milan
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
City
Udine
State/Province
UD
ZIP/Postal Code
33100
Country
Italy
City
Ancona
ZIP/Postal Code
60020
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
City
Jelenia Gora
ZIP/Postal Code
58-506
Country
Poland
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200385
Country
Romania
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
City
Kazan
State/Province
Tatarstan Republic
ZIP/Postal Code
420029
Country
Russian Federation
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
City
Hull
State/Province
East Yorks
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
City
Chelmsford
State/Province
Essex
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G12 OYN
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L69 3GA
Country
United Kingdom
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
City
Salisbury
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

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