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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01395017




Registration number
NCT01395017
Ethics application status
Date submitted
8/07/2011
Date registered
15/07/2011
Date last updated
8/04/2016

Titles & IDs
Public title
Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
Scientific title
Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
Secondary ID [1] 0 0
287-11-201
Universal Trial Number (UTN)
Trial acronym
LAPC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dasatinib
Treatment: Drugs - Placebo

Active comparator: Group 1 - 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).

Placebo comparator: Group 2 - 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).


Treatment: Drugs: dasatinib
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.

Treatment: Drugs: Placebo
Matching Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From randomization until date of death from any cause by 02 December 2013
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Time from randomization to earliest PFS event by 02 December 2013

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
202
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Blacktown
Recruitment hospital [2] 0 0
- Liverpool
Recruitment hospital [3] 0 0
- Tweed Heads
Recruitment hospital [4] 0 0
- Footscray
Recruitment hospital [5] 0 0
- Frankston
Recruitment hospital [6] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [4] 0 0
3011 - Footscray
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Kansas
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Wien
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Olomouc
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Pardubice
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Prague 8
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Zlin
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Baranya
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Gyor
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MI
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UD
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Italy
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Ancona
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Reggio Emilia
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Jelenia Gora
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Lublin
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Dolj
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Bucharest
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Cluj-Napoca
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Russian Federation
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Tatarstan Republic
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Chelyabinsk
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Krasnodar
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Moscow
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Voronezh
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Salisbury
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Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01395017
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01395017