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0822GCC: Phase 2 Study of Efficacy and Safety of Apricoxib/Placebo With Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00771953
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : July 22, 2013
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
Tragara Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Maryland, Baltimore

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Lung Cancer
Non Small Cell Lung Cancer
Interventions Drug: apricoxib
Drug: Placebo
Drug: Docetaxel or Pemetrexed
Enrollment 109
Recruitment Details University Medical Centers and Hospital Based Oncology Programs recruited participants from November 2011 through August 2011
Pre-assignment Details 110 patients started a 5 day run in period with 400mg apricoxib. 7 did not complete due to AEs, and 23 did not have at least 50% drop in PGE-M (randomization requirement). Of the remaining 80, 2 withdrew, 2 were ineligible by physician discretion, 1 died and 3 had progressive disease. Thus, 72 patients were randomized.
Arm/Group Title Apricoxib Plus Docetaxel or Pemetrexed Placebo Plus Docetaxel or Pemetrexed
Hide Arm/Group Description Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
Period Title: Overall Study
Started 36 36
Completed 26 26
Not Completed 10 10
Reason Not Completed
Adverse Event             5             3
Death             2             2
Progression before active Tx             1             2
Sponsor decision             1             0
Other complicating disease             1             0
Withdrawal by Subject             0             3
Arm/Group Title Apricoxib Plus Docetaxel or Pemetrexed Placebo Plus Docetaxel or Pemetrexed Total
Hide Arm/Group Description Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days Total of all reporting groups
Overall Number of Baseline Participants 36 36 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 36 participants 36 participants 72 participants
62
(42 to 87)
66
(49 to 76)
64
(42 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Female
16
  44.4%
16
  44.4%
32
  44.4%
Male
20
  55.6%
20
  55.6%
40
  55.6%
1.Primary Outcome
Title Progression Free Survival
Hide Description For determining progression-free survival, progression was determined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame From the date of randomization until the first date that recurrent or progressive disease is objectively documented.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apricoxib Plus Docetaxel Placebo Plus Docetaxel Apricoxib Plus Pemetrexed Placebo Plus Pemetrexed
Hide Arm/Group Description:
Apricoxib 400mg qd plus docetaxel 75mg/m2 q21 days
Placebo plus docetaxel 75mg/m2 q21 days
Apricoxib 400mg qd plus pemetrexed 500mg/m2 q21 days
Placebo plus pemetrexed 500mg/m2 q21 days
Overall Number of Participants Analyzed 17 20 19 16
Median (95% Confidence Interval)
Unit of Measure: days
75
(47 to 104)
97
(48 to 216)
103
(62 to 225)
98
(37 to 197)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Apricoxib Plus Docetaxel or Pemetrexed Placebo Plus Docetaxel or Pemetrexed
Hide Arm/Group Description Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
All-Cause Mortality
Apricoxib Plus Docetaxel or Pemetrexed Placebo Plus Docetaxel or Pemetrexed
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Apricoxib Plus Docetaxel or Pemetrexed Placebo Plus Docetaxel or Pemetrexed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/36 (30.56%)      11/36 (30.56%)    
Blood and lymphatic system disorders     
Febrile neutropenia *  0/36 (0.00%)  0 1/36 (2.78%)  1
Neutropenia   0/36 (0.00%)  0 2/36 (5.56%)  3
Granulocytopenia   1/36 (2.78%)  1 0/36 (0.00%)  0
Thrombosis *  0/36 (0.00%)  0 2/36 (5.56%)  2
Cardiac disorders     
Atrial flutter *  1/36 (2.78%)  1 0/36 (0.00%)  0
Gastrointestinal disorders     
Colonic perforation *  1/36 (2.78%)  1 0/36 (0.00%)  0
General disorders     
Abdominal pain *  0/36 (0.00%)  0 2/36 (5.56%)  2
Chest pain *  0/36 (0.00%)  0 1/36 (2.78%)  1
Coumadin toxicity *  1/36 (2.78%)  1 0/36 (0.00%)  0
Dehydration *  0/36 (0.00%)  0 1/36 (2.78%)  1
Headache *  1/36 (2.78%)  1 1/36 (2.78%)  1
Hyperkalemia   1/36 (2.78%)  2 0/36 (0.00%)  0
Hypernatremia   0/36 (0.00%)  0 1/36 (2.78%)  1
Hyponatremia   0/36 (0.00%)  0 1/36 (2.78%)  1
Hypoxia *  1/36 (2.78%)  1 1/36 (2.78%)  1
Hepatobiliary disorders     
Creatinine increase   0/36 (0.00%)  0 1/36 (2.78%)  1
Hypoglycemia *  1/36 (2.78%)  1 0/36 (0.00%)  0
Infections and infestations     
Infection *  1/36 (2.78%)  1 0/36 (0.00%)  0
Pneumonia *  0/36 (0.00%)  0 1/36 (2.78%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Death * [1]  0/36 (0.00%)  0 1/36 (2.78%)  1
Nervous system disorders     
Aseptic meningitis *  1/36 (2.78%)  1 0/36 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchitis *  1/36 (2.78%)  1 0/36 (0.00%)  0
CPOD exacerbation *  1/36 (2.78%)  1 0/36 (0.00%)  0
Cough *  0/36 (0.00%)  0 1/36 (2.78%)  1
Dyspnea *  2/36 (5.56%)  2 0/36 (0.00%)  0
Pulmonary embolism *  1/36 (2.78%)  1 0/36 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
progressive disease
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Apricoxib Plus Docetaxel or Pemetrexed Placebo Plus Docetaxel or Pemetrexed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/36 (33.33%)      11/36 (30.56%)    
Blood and lymphatic system disorders     
Leukopenia *  3/36 (8.33%)  3 0/36 (0.00%)  0
Lymphopenia *  1/36 (2.78%)  1 3/36 (8.33%)  3
Neutropenia *  9/36 (25.00%)  9 9/36 (25.00%)  10
Lowered WBC count *  2/36 (5.56%)  3 1/36 (2.78%)  1
General disorders     
Hyponatremia *  2/36 (5.56%)  3 0/36 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
This study is limited by the relatively low numbers and the hetereogeneity between concurrent treatments (docetaxel vs. pemetrexed). However, in analyses stratified by docetaxel and pemetrexed, results for an affect of apricoxib were still null.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michelle Medeiros
Organization: University of Maryland Baltimore Greenebaum Cancer Center
Phone: 410-328-1160
EMail: mmedeiros@umm.edu
Publications:
Gitlitz BJ, et al. Apricot-l: Results of a biomarker-based phase II randomized placebocontrolled study of apricoxib in combination with erlotinib in non-small cell lung cancer (NSCLC) patients. Journal of Clinical Oncology 29: 2011 (suppl; abstr 7528)
Layout table for additonal information
Responsible Party: University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT00771953    
Other Study ID Numbers: HP-00043076; 0822GCC
UMGCC 0822 ( Other Identifier: University of Maryland Greenebaum Cancer Center )
First Submitted: October 10, 2008
First Posted: October 15, 2008
Results First Submitted: May 28, 2013
Results First Posted: July 22, 2013
Last Update Posted: October 30, 2019