Pancreatic CancerPhase 2NCT00709826
APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer
A Phase 2 study testing gemcitabine, Erlotinib and apricoxib in people with Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Tragara Pharmaceuticals, Inc. at 39 sites in United States.
Trial summary
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- What is being tested?
- gemcitabine, Erlotinib and apricoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 39 sitesUnited States
- Study dates
- Aug 2008to May 2011
- 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
- Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic.
- Life expectancy greater than or equal to 3 months.
- Patients must have measurable disease by RECIST.
- ECOG PS of 0, 1, or 2.
- Negative serum pregnancy test at the time of first dose for women of childbearing potential.
Who cannot join
- Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4).
- RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment.
- Evidence of New York Heart Association class III or greater cardiac disease.
- History of myocardial infarction, stroke, ventricular arrhythmia.
- Symptomatic central nervous system metastases.
- Pregnant or nursing women.
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- Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
- History of upper gastrointestinal bleeding, ulceration or perforation. History of lower GI bleeding, ulceration, or perforation within 12 months.
- Previous anti-EGFR kinase therapy.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
SJMH Cancer Center
Ann Arbor, Michigan, 48106
Cancer Care of WNC, PA
Asheville, North Carolina, 28801
Rush-Copley Medical Center
Aurora, Illinois, 60504
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Franklin Square Hospital Center/Harry and Jeanette Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, 21237
Southbay Oncology Hematology Partners
Campbell, California, 95008
Charleston Hematology Oncology Associates
Charleston, South Carolina, 29414
Bay Area Cancer Research Group, LLC
Concord, California, 94523
Coastal Bend Cancer Center
Corpus Christi, Texas, 78463
Samaritan Hematology * Oncology
Corvallis, Oregon, 97330
Alexian Brothers Medical Hospital Network
Elk Grove Village, Illinois, 60007
San Juan Oncology Associates
Farmington, New Mexico, 87401
Front Range Cancer Specialists
Fort Collins, Colorado, 80528
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
The Jones Clinic
Germantown, Tennessee, 38138
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534
The Queen's Medical Center Cancer Center
Honolulu, Hawaii, 96813
The Methodist Hospital
Houston, Texas, 77030
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46260
University of Iowa Hospitals
Iowa City, Iowa, 52242
Cascade Cancer Center
Kirkland, Washington, 98304
Tennessee Cancer Specialists
Knoxville, Tennessee, 37920
Hematology Oncology Associates
Lake Worth, Florida, 33461
Owsley Brown Frazier Cancer Center
Louisville, Kentucky, 40245
Jayne Gurtler, MD
Metairie, Louisiana, 70006
Medical Consultants, PC
Muncie, Indiana, 47303
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
Warren Hospital
Phillipsburg, New Jersey, 08865
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, 94523
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952
JTV Cancer Care Institute
Rapid City, South Dakota, 57701
North America Research Institute
San Dimas, California, 91773
Bronx River Medical Associates, P.C.
The Bronx, New York, 10467
Oncology Associates of Bridgeport
Trumball, Connecticut, 06611
Arizona Clinical Research Center
Tucson, Arizona, 85715
Associates in Hematology-Oncology PC
Upland, Pennsylvania, 19013
Berks Hematology-Oncology Associates, Ltd
West Reading, Pennsylvania, 19612
Southeastern Medical Oncology Center
Wilson, North Carolina, 27893
About this study
Official title: APRiCOT-P (Apricoxib in Combination Oncology Treatment - Pancreas): Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.
Read the detailed description
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by progression-free survival to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumors will have a clinical benefit compared with Gemcitabine/Erlotinib only.
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- Being tested
- gemcitabine, placebo, Erlotinib, apricoxib
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
Also called Gemcitabine - Gemzar
Gemcitabine: per package insert.
placeboDrug
Also called No other names
placebo: 100 mg tablets, 400 mg/day
ErlotinibDrug
Also called Erlotinib - Tarceva
Erlotinib - per package insert.
apricoxibDrug
Also called No other names
apricoxib: 100mg tablets, given orally
| Study group | Role | What they receive |
|---|---|---|
| apricoxib + gemcitabine + erlotinib | Experimental | 400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib Receives: Drug: gemcitabine; Drug: Erlotinib; Drug: apricoxib |
| placebo + gemcitabine + erlotinib | Placebo comparator | placebo + 1000mg/m2 gemcitabine + 100mg erlotinib Receives: Drug: gemcitabine; Drug: placebo; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
Measured: Randomization then every other cycle
Secondary outcomes (1)
Overall Survival
Measured: Randomization then every other cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2010
- Study completionMay 2011
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tragara Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tracy Parrott, Study director, Tragara Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709826
- Sponsor's protocol ID
- TP2001-203
- Other IDs
- APRiCOT-P
- Status last verified
- Oct 2012
- First submitted
- 1 Jul 2008
- Last updated
- 7 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APRiCOT-P (Apricoxib in Combination Oncology Treatment - Pancreas): Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00709826
- Acronym / sponsor ID
- TP2001-203
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Tragara Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Posted 7 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.
Detailed description
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by progression-free survival to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumors will have a clinical benefit compared with Gemcitabine/Erlotinib only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| apricoxib + gemcitabine + erlotinib | Experimental | Drug: gemcitabine, Drug: Erlotinib, Drug: apricoxib400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib |
| placebo + gemcitabine + erlotinib | Placebo comparator | Drug: gemcitabine, Drug: placebo, Drug: Erlotinibplacebo + 1000mg/m2 gemcitabine + 100mg erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic.
- Life expectancy greater than or equal to 3 months.
- Patients must have measurable disease by RECIST.
- ECOG PS of 0, 1, or 2.
- Negative serum pregnancy test at the time of first dose for women of childbearing potential.
Key exclusion criteria (9 listed)
- Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4).
- RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment.
- Evidence of New York Heart Association class III or greater cardiac disease.
- History of myocardial infarction, stroke, ventricular arrhythmia.
- Symptomatic central nervous system metastases.
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 |
|---|---|---|
| gemcitabineAlso: Gemcitabine - GemzarGemcitabine: per package insert. | Drug | apricoxib + gemcitabine + erlotinib, placebo + gemcitabine + erlotinib |
| placeboAlso: No other namesplacebo: 100 mg tablets, 400 mg/day | Drug | placebo + gemcitabine + erlotinib |
| ErlotinibAlso: Erlotinib - TarcevaErlotinib - per package insert. | Drug | apricoxib + gemcitabine + erlotinib, placebo + gemcitabine + erlotinib |
| apricoxibAlso: No other namesapricoxib: 100mg tablets, given orally | Drug | apricoxib + gemcitabine + erlotinib |
Primary outcome
Progression Free Survival
Time frame: Randomization then every other cycle
Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
1 secondary outcome
Overall Survival
Time frame: Randomization then every other cycle
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
- 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.
Tracy Parrott study director
Tragara Pharmaceuticals, Inc.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine, Erlotinib and apricoxib in people with Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Tragara Pharmaceuticals, Inc. at 39 sites in United States.
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 5 inclusion and 9 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 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. 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 7 Nov 2012). 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?
Progression Free Survival (time frame: Randomization then every other cycle). 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 7 Nov 2012.