Breast CancerPhase 2APRiCOT-BNCT00657137
APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)
A Phase 2 study testing apricoxib + lapatinib + capecitabine in people with Breast Cancer, run by Tragara Pharmaceuticals, Inc. at 44 sites in United States.
Trial summary
This study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate urinary PGE-M measurements or baseline COX-2 expression in tumor tissue by IHC as a surrogate selection criterion for patients who will… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- apricoxib + lapatinib + capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 44 sitesUnited States
- Study dates
- Apr 2008to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females with pathologically determined locally advanced or metastatic human epidermal growth factor receptor 2 positive (HER2/neu+) breast cancer
- Have progressed after treatment with chemotherapy including a taxane and trastuzumab
- Must have measurable disease by RECIST
- ECOG PS of 0,1, or 2
- MUGA scan or echocardiogram results show left ventricular ejection fraction greater than or equal to 50%
Who cannot join
- Radiation therapy within 2 weeks, chemotherapy within 3 weeks, or noncytoxic investigational agents within 4 weeks of initiating study treatment
- Evidence of New York Heart Association class III or greater cardiac disease
- History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality
- History of congenital QT prolongation
- Concurrent severe or uncontrolled medical disease
- Symptomatic central nervous system metastases
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- Pregnant or nursing women
- Hypersensitivity or intolerance to apricoxib, lapatinib, capecitabine, 5-FU, sulfonamides, aspirin, or NSAIDs
- Severe renal insufficiency
- History of upper GI bleeding, ulceration, or perforation- Concurrent use of potent CYP3A4 inhibitors and CYP3A4 inducers
- Prior treatment with capecitabine
- Patients on anti-arrhythmic treatment
- Prior lapatinib therapy
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
SJMH Cancer Center
Ann Arbor, Michigan
Comprehensive Blood and Cancer Center
Bakersfield, California
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California
Fletcher Allen Healthcare Inc.
Burlington, Vermont
Charleston Oncology Hematology Associates
Charleston, South Carolina
Bay Area Cancer Research Group, LLC
Concord, California
Samaritan Hematology and Oncology Consulting
Corvallis, Oregon
San Juan Oncology Associates
Farmington, New Mexico
Genesys Hurley Cancer Center Institute
Flint, Michigan
Front Range Cancer Specialists
Fort Collins, Colorado
St. Jude Heritage Healthcare
Fullerton, California
University of Texas Medical Branch
Galveston, Texas
St. Francis Cancer Treatment Center
Grand Island, Nebraska
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania
Jabboury Foundation for Cancer Research Inc
Houston, Texas
The Methodist Hospital Research Institute
Houston, Texas
Wilshire Oncology Medical Group Inc
Inland Valleys/Pomona, California
Foote Health System
Jackson County, Michigan
Baptist Regional Cancer Center
Knoxville, Tennessee
Hematology Oncology Associates
Lake Worth, Florida
Bresline Cancer Center at Michigan State University
Lansing, Michigan
Suburban Hematology-Oncology Associates
Lawrenceville, Georgia
St. Mary Mercy Hospital
Livonia, Michigan
UCLA
Los Angeles, California
Warren Billhartz Cancer Center
Maryville, Illinois
Medical Consultants PC
Muncie, Indiana
Peninsula Cancer Institute
Newport News, Virginia
Mid-Illinois Hematology Oncology Associates
Normal, Illinois
Olive View- UCLA Medical Center
Olive View, California
MD Anderson Cancer Center in Orlando
Orlando, Florida
Eastern Regional Medical Center
Philadelphia, Pennsylvania
Warren Hospital
Phillipsburg, New Jersey
Mercy Hospital
Port Huron, Michigan
Providence Portland Medical Center
Portland, Oregon
Cancer Care Associates Medical Group Inc
Redondo Beach, California
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont
St. Mary's of Michigan
Saginaw, Michigan
North America Research Institute
San Dimas, California
Central Coast Medical Oncology Corporation
Santa Maria, California
Flower Hospital Cancer Center
Sylvania, Ohio
Madigan Army Medical Center
Tacoma, Washington
University of Toledo
Toledo, Ohio
Arizona Clinical Research Center
Tucson, Arizona
Associates in Hematology-Oncology PC
Upland, Pennsylvania
About this study
Official title: A Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of Patients With HER2/Neu+ Breast Cancer Who Have Failed Trastuzumab and Chemotherapy Including a Taxane
This study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate urinary PGE-M measurements or baseline COX-2 expression in tumor tissue by IHC as a surrogate selection criterion for patients who will benefit from future treatment with apricoxib.
- Conditions
- Breast Cancer
- Being tested
- apricoxib + lapatinib + capecitabine, placebo + lapatinib + capecitabine
- Keywords
- HER2/neu positive, locally advanced or metastatic
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apricoxib + lapatinib + capecitabineDrug
apricoxib: 100 mg tablets, 400 mg/day
lapatinib: per package insert
capecitabine: per package insert
placebo + lapatinib + capecitabineDrug
placebo: 100 mg tablets, 400 mg/day
lapatinib: per package insert
capecitabine: per package insert
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | apricoxib + lapatinib + capecitabine Receives: Drug: apricoxib + lapatinib + capecitabine |
| B | Placebo comparator | placebo + lapatinib + capecitabine Receives: Drug: placebo + lapatinib + capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the anti-tumor activity of the combination of apricoxib/lapatinib-capecitabine compared with placebo/lapatinib-capecitabine as measured by time to disease progression.
Measured: Time to disease progression
Secondary outcomes (1)
Progression-free survival and safety/tolerability
Measured: Time to disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tragara Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Zaknoen, M.D., Study director, Tragara Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657137
- Sponsor's protocol ID
- TP2001-202
- Other IDs
- APRiCOT-B
- Acronym
- APRiCOT-B
- Status last verified
- Mar 2012
- First submitted
- 31 Mar 2008
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of Patients With HER2/Neu+ Breast Cancer Who Have Failed Trastuzumab and Chemotherapy Including a Taxane
- ClinicalTrials.gov ID
- NCT00657137
- Acronym / sponsor ID
- APRiCOT-B / TP2001-202
- Conditions
- Breast Cancer
- Keywords
- HER2/neu positive, locally advanced or metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tragara Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Not posted in the source record
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 lapatinib/capecitabine with placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate urinary PGE-M measurements or baseline COX-2 expression in tumor tissue by IHC as a surrogate selection criterion for patients who will benefit from future treatment with apricoxib.
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 |
|---|---|---|
| A | Experimental | Drug: apricoxib + lapatinib + capecitabineapricoxib + lapatinib + capecitabine |
| B | Placebo comparator | Drug: placebo + lapatinib + capecitabineplacebo + lapatinib + capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females with pathologically determined locally advanced or metastatic human epidermal growth factor receptor 2 positive (HER2/neu+) breast cancer
- Have progressed after treatment with chemotherapy including a taxane and trastuzumab
- Must have measurable disease by RECIST
- ECOG PS of 0,1, or 2
- MUGA scan or echocardiogram results show left ventricular ejection fraction greater than or equal to 50%
Key exclusion criteria (13 listed)
- Radiation therapy within 2 weeks, chemotherapy within 3 weeks, or noncytoxic investigational agents within 4 weeks of initiating study treatment
- Evidence of New York Heart Association class III or greater cardiac disease
- History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality
- History of congenital QT prolongation
- Concurrent severe or uncontrolled medical disease
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 |
|---|---|---|
| apricoxib + lapatinib + capecitabineapricoxib: 100 mg tablets, 400 mg/day lapatinib: per package insert capecitabine: per package insert | Drug | A |
| placebo + lapatinib + capecitabineplacebo: 100 mg tablets, 400 mg/day lapatinib: per package insert capecitabine: per package insert | Drug | B |
Primary outcome
To determine the anti-tumor activity of the combination of apricoxib/lapatinib-capecitabine compared with placebo/lapatinib-capecitabine as measured by time to disease progression.
Time frame: Time to disease progression
1 secondary outcome
Progression-free survival and safety/tolerability
Time frame: Time to disease progression
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
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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.
Sara Zaknoen, M.D. study director
Tragara Pharmaceuticals, Inc.
44 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 apricoxib + lapatinib + capecitabine in people with Breast Cancer, run by Tragara Pharmaceuticals, Inc. at 44 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 13 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: stopped early, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 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?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
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?
To determine the anti-tumor activity of the combination of apricoxib/lapatinib-capecitabine compared with placebo/lapatinib-capecitabine as measured by time to disease progression. (time frame: Time to disease progression). 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 15 Mar 2012.