Pancreatic CancerPhase 2LAPCNCT01395017
Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
A Phase 2 study testing dasatinib in people with Pancreatic Cancer, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 74 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- dasatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 74 sitesin 15 countries
- Study dates
- Jun 2011to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
74 sites in 15 countries.
74 sites in 15 countries
United Kingdom13 sites
Study site
Chelmsford, Essex, CM1 7ET
Study site
Edinburgh, EH4 2XU
Study site
Glasgow, G12 OYN
Study site
Hull, East Yorks, HU16 5JQ
Study site
Leeds, West Yorkshire, LS9 7TF
Study site
Liverpool, L69 3GA
Study site
London, SW3 6JJ
Study site
London, W12 0HS
Study site
Maidstone, Kent, ME16 9QQ
Study site
Metropolitan Borough of Wirral, CH63 4JY
Study site
Northwood, Middlesex, HA6 2RN
Study site
Salisbury, SP2 8BJ
Study site
Sutton, Surrey, SM2 5PT
United States11 sites
Study site
Albuquerque, New Mexico, 87131
Study site
Aurora, Colorado, 80045
Study site
Bethlehem, Pennsylvania, 18015
Study site
Birmingham, Alabama, 35249
Study site
Boynton Beach, Florida, 33426
Study site
Los Angeles, California, 90095
Study site
Minneapolis, Minnesota, 55455
Study site
Orange, California, 92868
Study site
San Francisco, California, 94115
Study site
Tampa, Florida, 33606
Study site
Wichita, Kansas, 67214
France9 sites
Study site
Angers, Maine-et-Loire, 49933
Study site
Besançon, 25030
Study site
Clermont-Ferrand, Auvergne, 63003
Study site
Clichy, 92110
Study site
Lille, 59037
Study site
Lyon, 69437
Study site
Paris, Cedex 14, 75674
Study site
Saint-Priest-en-Jarez, Pays de la Loire Region, 42271
Study site
Saint-Priest-en-Jarez, 42277
Australia6 sites
Study site
Blacktown, New South Wales, 2148
Study site
Footscray, Victoria, 3011
Study site
Frankston, Victoria, 3199
Study site
Liverpool, New South Wales, 2170
Study site
Parkville, Victoria, 3050
Study site
Tweed Heads, New South Wales, 2485
Russia5 sites
Study site
Chelyabinsk, 454087
Study site
Kazan', Tatarstan Republic, 420029
Study site
Krasnodar, 350040
Study site
Moscow, 115478
Study site
Voronezh, 394000
Czechia4 sites
Study site
Olomouc, 77520
Study site
Pardubice, 532 03
Study site
Prague, 180 81
Study site
Zlín, 76275
Germany4 sites
Study site
Cologne, 50937
Study site
Hamburg, 20249
Study site
München, 81925
Study site
Tübingen, Baden-Wurttemberg, 72076
Hungary4 sites
Study site
Budapest, 1097
Study site
Budapest, 1122
Study site
Győr, 9024
Study site
Pécs, Baranya, 7624
Italy4 sites
Study site
Ancona, 60020
Study site
Milan, MI, 20133
Study site
Reggio Emilia, 42100
Study site
Udine, UD, 33100
Belgium3 sites
Study site
Brussels, 1200
Study site
Ghent, 9000
Study site
Leuven, 3000
Canada3 sites
Study site
Montreal, Quebec, H2X 3J4
Study site
Toronto, Ontario, M4N 3M5
Study site
Toronto, Ontario, M5G 2M9
Poland3 sites
Study site
Jelenia Góra, 58-506
Study site
Lublin, 20-090
Study site
Olsztyn, 10-228
Romania3 sites
Study site
Bucharest, Bucharest, 022328
Study site
Cluj-Napoca, 400015
Study site
Craiova, Dolj, 200385
About this study
Official title: Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
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.
- Conditions
- Pancreatic Cancer
- Being tested
- dasatinib, Placebo
- Keywords
- Pancreatic cancer, Dasatinib, chemotherapy, Locally advanced
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dasatinibDrug
Also called BMS-354825
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.
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 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). Receives: Drug: dasatinib |
| Group 2 | Placebo comparator | 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.
Measured: From randomization until date of death from any cause by 02 December 2013
Secondary outcomes (1)
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.
Measured: Time from randomization to earliest PFS event by 02 December 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2013
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395017
- Sponsor's protocol ID
- 287-11-201
- Acronym
- LAPC
- Status last verified
- Mar 2016
- First submitted
- 8 Jul 2011
- Last updated
- 8 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01395017
- Acronym / sponsor ID
- LAPC / 287-11-201
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Dasatinib, chemotherapy, Locally advanced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Jul 2011 (estimated)
- Results
- Posted 17 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: dasatinibOne 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). |
| Group 2 | Placebo comparator | Drug: PlaceboThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dasatinibAlso: BMS-354825GEM 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. | Drug | Group 1 |
| PlaceboMatching Placebo | Drug | Group 2 |
Primary outcome
Overall Survival
Time frame: From randomization until date of death from any cause by 02 December 2013
Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.
1 secondary outcome
Progression Free Survival (PFS)
Time frame: Time from randomization to earliest PFS event by 02 December 2013
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
74 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dasatinib in people with Pancreatic Cancer, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 74 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United Kingdom, United States, France, Australia, Russia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From randomization until date of death from any cause by 02 December 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2016.