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APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer (TP2001-201)

Primary Purpose

Recurrent Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
apricoxib/erlotinib
erlotinib/placebo
Sponsored by
Tragara Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Time to Disease Progression (TDP)

Secondary Outcome Measures

Overall Survival

Full Information

First Posted
March 31, 2008
Last Updated
March 13, 2012
Sponsor
Tragara Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00652340
Brief Title
APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer
Acronym
TP2001-201
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tragara Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 erlotinib alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
apricoxib/erlotinib
Intervention Description
apricoxib: 100 mg tablets, 400mg/day erlotinib: per package insert
Intervention Type
Drug
Intervention Name(s)
erlotinib/placebo
Intervention Description
erlotinib: per package insert placebo: 100 mg tablets, 400 mg/day
Primary Outcome Measure Information:
Title
Time to Disease Progression (TDP)
Time Frame
Baseline and every other cycle.
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
Randomization and every cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Parrott
Organizational Affiliation
Tragara Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
Country
United States
City
Bakersfield
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Rancho Mirage
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
San Dimas
State/Province
California
Country
United States
City
Stockton
State/Province
California
Country
United States
City
Norwich
State/Province
Connecticut
Country
United States
City
Lake North
State/Province
Florida
Country
United States
City
Lakeland
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Savannah
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Kokomo
State/Province
Indiana
Country
United States
City
New Albany
State/Province
Indiana
Country
United States
City
Waterloo
State/Province
Iowa
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Jackson
State/Province
Michigan
Country
United States
City
Lansing
State/Province
Michigan
Country
United States
City
Livonia
State/Province
Michigan
Country
United States
City
Saginaw
State/Province
Michigan
Country
United States
City
St. Joseph
State/Province
Michigan
Country
United States
City
Robbinsdale
State/Province
Minnesota
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Neptune
State/Province
New Jersey
Country
United States
City
Elmhurst
State/Province
New York
Country
United States
City
Stony Brook
State/Province
New York
Country
United States
City
Gastonia
State/Province
North Carolina
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Akron
State/Province
Ohio
Country
United States
City
Canton
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Jefferson City
State/Province
Ohio
Country
United States
City
Sylvania
State/Province
Ohio
Country
United States
City
Corvallis
State/Province
Oregon
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Upland
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
Galveston
State/Province
Texas
Country
United States
City
Newport News
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Tacoma
State/Province
Washington
Country
United States
City
Huntington
State/Province
West Virginia
Country
United States
City
Morgantown
State/Province
West Virginia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24736085
Citation
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.
Results Reference
derived

Learn more about this trial

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

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