Recurrent Non Small Cell Lung CancerPhase 2TP2001-201NCT00652340

APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer

A Phase 2 study testing apricoxib/erlotinib in people with Recurrent Non Small Cell Lung Cancer, run by Tragara Pharmaceuticals, Inc. at 47 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will compare the anti-tumor efficacy of apricoxib and erlotinib with placebo and erlotinib as measured by time to disease progression to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumor will have a clinical benefit compared with… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Non Small Cell Lung Cancer
What is being tested?: apricoxib/erlotinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 47 sitesUnited States
Study dates: Apr 2008to Mar 2012
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

Pathologically determined Stage IV NSCLC including Stage IIIb (pleural effusion)
Failed at least one prior platinum-based chemotherapy for Stage IIIb or Stage IV NSCLC. Patients receiving platinum-based chemotherapy only given in an adjuvant setting are not eligible.
Measurable disease by RECIST
Greater than or equal to 18 years of age
ECOG PS of 0 or 1

Who cannot join

Radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic investigational agents within 4 weeks of initiating study treatment
Evidence of NYHA class III or greater cardiac disease
History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months
Known HIV infection or AIDS
Symptomatic CNS metastases
Pregnant or nursing women

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Hypersensitivity or intolerance to erlotinib, sulfonamides, aspirin, or other NSAIDs.
History of upper GI bleeding, ulceration, or perforation
Prior history of COX-2 inhibitor therapy for the treatment of metastatic NSCLC
Previous anti-EGFR kinase therapy

Trial locations and contacts

47 sites in 1 country.

City, postcode or hospital

47 sites in 1 country

United States47 sites

Study site
Akron, Ohio
Study site
Ann Arbor, Michigan
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Arlington, Texas
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Bakersfield, California
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Canton, Ohio
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Charleston, South Carolina
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Chicago, Illinois
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Columbus, Ohio
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Corvallis, Oregon
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Elmhurst, New York
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Galveston, Texas
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Gastonia, North Carolina
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Huntington, West Virginia
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Jackson, Michigan
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Jefferson, Ohio
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Kokomo, Indiana
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Lake North, Florida
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Lakeland, Florida
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Lansing, Michigan
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Livonia, Michigan
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Los Angeles, California
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Louisville, Kentucky
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Miami, Florida
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Morgantown, West Virginia
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Neptune City, New Jersey
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New Albany, Indiana
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New Orleans, Louisiana
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Newport News, Virginia
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Norwich, Connecticut
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Portland, Oregon
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Rancho Mirage, California
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Richmond, Virginia
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Robbinsdale, Minnesota
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Saginaw, Michigan
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Saint Joseph, Michigan
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San Diego, California
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San Dimas, California
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Savannah, Georgia
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St Louis, Missouri
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Stockton, California
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Stony Brook, New York
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Sylvania, Ohio
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Tacoma, Washington
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Tucson, Arizona
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Upland, Pennsylvania
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Waterloo, Iowa
Study site
Wilmington, North Carolina

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About this study

Official title: APRiCOT-L (Apricoxib in Combination Oncology Treatment - Lung) A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients

Conditions: Recurrent Non Small Cell Lung Cancer
Being tested: apricoxib/erlotinib, erlotinib/placebo
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

apricoxib/erlotinibDrug
apricoxib: 100 mg tablets, 400mg/day
erlotinib: per package insert
erlotinib/placeboDrug
erlotinib: per package insert
placebo: 100 mg tablets, 400 mg/day

Study groups in NCT00652340
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: apricoxib/erlotinib
B	Placebo comparator	Not described Receives: Drug: erlotinib/placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Disease Progression (TDP)
Measured: Baseline and every other cycle.

Secondary outcomes (1)

Overall Survival
Measured: Randomization and every cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Mar 2012

First posted3 Apr 2008 (estimated)
Study startApr 2008
Primary completionJun 2010
Study completionMar 2012

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Recurrent Non Small Cell Lung 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: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00652340
Sponsor's protocol ID: TP2001-201
Other IDs: APRiCOT-L
Acronym: TP2001-201
Status last verified: Mar 2012
First submitted: 31 Mar 2008
Last updated: 9 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Gitlitz BJ, Bernstein E, Santos ES, Otterson GA, Milne G, Syto M, Burrows F, Zaknoen S. A randomized, placebo-controlled, multicenter, biomarker-selected, phase 2 study of apricoxib in combination with erlotinib in patients with advanced non-small-cell lung cancer. J Thorac Oncol. 2014 Apr;9(4):577-82. doi: 10.1097/JTO.0000000000000082.
PubMed 24736085

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: APRiCOT-L (Apricoxib in Combination Oncology Treatment - Lung) A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients
ClinicalTrials.gov ID: NCT00652340
Acronym / sponsor ID: TP2001-201 / TP2001-201
Conditions: Recurrent Non Small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Tragara Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Jun 2010 (actual)
Study completion: Mar 2012 (actual)
First posted: 3 Apr 2008 (estimated)
Results: Posted 9 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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/erlotinib
B	Placebo comparator	Drug: erlotinib/placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Pathologically determined Stage IV NSCLC including Stage IIIb (pleural effusion)
Failed at least one prior platinum-based chemotherapy for Stage IIIb or Stage IV NSCLC. Patients receiving platinum-based chemotherapy only given in an adjuvant setting are not eligible.
Measurable disease by RECIST
Greater than or equal to 18 years of age
ECOG PS of 0 or 1

Key exclusion criteria (10 listed)

Radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic investigational agents within 4 weeks of initiating study treatment
Evidence of NYHA class III or greater cardiac disease
History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months
Known HIV infection or AIDS
Symptomatic CNS 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
apricoxib/erlotinibapricoxib: 100 mg tablets, 400mg/day erlotinib: per package insert	Drug	A
erlotinib/placeboerlotinib: per package insert placebo: 100 mg tablets, 400 mg/day	Drug	B

Primary outcome

Time to Disease Progression (TDP)
Time frame: Baseline and every other cycle.

1 secondary outcome

Overall Survival
Time frame: Randomization and every cycle

Results and safety

Results posted to the registry on 9 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Apricoxib/Erlotinib	78	74
Placebo/Erlotinib	42	39

Primary outcome: Time to Disease Progression (TDP)

Time frame: Baseline and every other cycle.. Median (95% Confidence Interval). Unit: months

Measure	Apricoxib/Erlotinib n = 78	Placebo/Erlotinib n = 42
Value	1.80 (1.40 to 2.80)	2.10 (1.40 to 4.00)

Population analysed: A 1-sided log rank test was used to achieve 80% power at an α=0.20 significance level to detect a difference of 0.13 between the proportions of patients who are progression free in AP/E (0.34) and P/E (0.21) after 5 months; an overall sample size of 115 patients (77 in AP/E and 38 in P/E) will be randomized in a 2:1 ratio in this study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: First dose of study drug to 30 days after last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Apricoxib/Erlotinib	13 of 78 (16.7%)	77 of 78 (98.7%)	Not reported
Placebo/Erlotinib	4 of 42 (9.5%)	42 of 42 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24736085Gitlitz BJ, Bernstein E, Santos ES, Otterson GA, Milne G, Syto M, Burrows F, Zaknoen S. A randomized, placebo-controlled, multicenter, biomarker-selected, phase 2 study of apricoxib in combination with erlotinib in patients with advanced non-small-cell lung cancer. J Thorac Oncol. 2014 Apr;9(4):577-82. doi: 10.1097/JTO.0000000000000082.

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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.

47 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/erlotinib in people with Recurrent Non Small Cell Lung Cancer, run by Tragara Pharmaceuticals, Inc. at 47 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 10 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 9 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 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 9 Apr 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?

Time to Disease Progression (TDP) (time frame: Baseline and every other cycle.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00652340, which also lists 1 linked publication.

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 9 Apr 2012.