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APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00709826
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : November 7, 2012
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
Tragara Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pancreatic Cancer
Metastatic Pancreatic Cancer
Interventions Drug: gemcitabine
Drug: placebo
Drug: Erlotinib
Drug: apricoxib
Enrollment 109
Recruitment Details Study opened to accrual in August 2008. Enrollment closed on November 2010. One hundred and nine patients were randomized. Patients were recruited from clinical oncology practices.
Pre-assignment Details  
Arm/Group Title Apricoxib/Gemcitabine/Erlotinib Placebo/Gemcitabine/Erlotinib
Hide Arm/Group Description Patients randomized to receive apricoxib + gemcitabine + erlotinib. Patients randomized to receive placebo + gemcitabine + erlotinib.
Period Title: Overall Study
Started 70 39
Completed 68 38
Not Completed 2 1
Arm/Group Title Apricoxib/Gemcitabine/Erlotinib Placebo/Gemcitabine/Erlotinib Total
Hide Arm/Group Description Patients randomized to receive apricoxib + gemcitabine + erlotinib. Patients randomized to receive placebo + gemcitabine + erlotinib. Total of all reporting groups
Overall Number of Baseline Participants 70 39 109
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 39 participants 109 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
  54.3%
17
  43.6%
55
  50.5%
>=65 years
32
  45.7%
22
  56.4%
54
  49.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 39 participants 109 participants
63  (64.2) 67  (66) 64  (64.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 39 participants 109 participants
Female
41
  58.6%
22
  56.4%
63
  57.8%
Male
29
  41.4%
17
  43.6%
46
  42.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 70 participants 39 participants 109 participants
70 39 109
1.Primary Outcome
Title Progression Free Survival
Hide Description 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.
Time Frame Randomization then every other cycle
Hide Outcome Measure Data
Hide Analysis Population Description
A 1-sided log rank test was used to achieve 80% power at an α=0.20 significance level to detect a difference of 0.16 between the proportions of patients who were progression free in AP/EG (0.35) and P/EG (0.19) after 9 months; an overall sample size of approximately 110 patients (73 in AP/EG and 37 in P/EG) was randomized in a 2:1 ratio.
Arm/Group Title Apricoxib/Gemcitabine/Erlotinib Placebo/Gemcitabine/Erlotinib
Hide Arm/Group Description:
Patients randomized to receive apricoxib + gemcitabine + erlotinib.
Patients randomized to receive placebo + gemcitabine + erlotinib.
Overall Number of Participants Analyzed 70 39
Median (95% Confidence Interval)
Unit of Measure: Months
3.0
(2.57 to 6.47)
2.8
(2.63 to 4.60)
2.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Randomization then every other cycle
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apricoxib/Gemcitabine/Erlotinib Placebo/Gemcitabine/Erlotinib
Hide Arm/Group Description:
Patients randomized to receive apricoxib + gemcitabine + erlotinib.
Patients randomized to receive placebo + gemcitabine + erlotinib.
Overall Number of Participants Analyzed 70 39
Median (95% Confidence Interval)
Unit of Measure: Months
5.0
(3.67 to 50.47)
4.8
(4.07 to 5.70)
Time Frame First dose of study drug to 30 days after last dose of study drug
Adverse Event Reporting Description Only drug-related serious adverse events are listed.
 
Arm/Group Title Apricoxib/Gemcitabine/Erlotinib Placebo/Gemcitabine/Erlotinib
Hide Arm/Group Description Patients randomized to receive apricoxib + gemcitabine + erlotinib. Patients randomized to receive placebo + gemcitabine + erlotinib.
All-Cause Mortality
Apricoxib/Gemcitabine/Erlotinib Placebo/Gemcitabine/Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Apricoxib/Gemcitabine/Erlotinib Placebo/Gemcitabine/Erlotinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/70 (22.86%)      5/39 (12.82%)    
Blood and lymphatic system disorders     
Anemia  1  1/70 (1.43%)  1 0/39 (0.00%)  0
Cardiac disorders     
Myocardial infarction  1  0/70 (0.00%)  0 1/39 (2.56%)  1
Gastrointestinal disorders     
Duodenal ulcer perforation  1  1/70 (1.43%)  1 0/39 (0.00%)  0
Gastrointestinal hemorrhage  1  5/70 (7.14%)  5 0/39 (0.00%)  0
Nausea  1  1/70 (1.43%)  1 0/39 (0.00%)  0
Esophagitis ulcerative  1  1/70 (1.43%)  1 0/39 (0.00%)  0
Ulcer  1  1/70 (1.43%)  1 0/39 (0.00%)  0
Vomiting  1  1/70 (1.43%)  1 1/39 (2.56%)  1
Infections and infestations     
Pneumocystis jiroveci pneumonia  1  1/70 (1.43%)  1 0/39 (0.00%)  0
Sepsis  1  1/70 (1.43%)  1 0/39 (0.00%)  0
Investigations     
International normalized ratio increased  1  1/70 (1.43%)  1 0/39 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/70 (1.43%)  1 0/39 (0.00%)  0
Failure to thrive  1  0/70 (0.00%)  0 1/39 (2.56%)  1
Nervous system disorders     
Headache  1  0/70 (0.00%)  0 1/39 (2.56%)  1
Renal and urinary disorders     
Renal failure  1  1/70 (1.43%)  1 0/39 (0.00%)  0
Renal failure acute  1  1/70 (1.43%)  1 0/39 (0.00%)  0
Vascular disorders     
Cerebrovascular accident  1  1/70 (1.43%)  1 0/39 (0.00%)  0
Embolic stroke  1  0/70 (0.00%)  0 1/39 (2.56%)  1
Pulmonary embolism  1  1/70 (1.43%)  1 0/39 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Apricoxib/Gemcitabine/Erlotinib Placebo/Gemcitabine/Erlotinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   70/70 (100.00%)      39/39 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  37/70 (52.86%)  37 18/39 (46.15%)  18
Thrombocytopenia  1  29/70 (41.43%)  29 14/39 (35.90%)  14
Neutropenia  1  21/70 (30.00%)  21 13/39 (33.33%)  13
Gastrointestinal disorders     
Diarrhea  1  41/70 (58.57%)  41 17/39 (43.59%)  17
Nausea  1  41/70 (58.57%)  41 15/39 (38.46%)  15
Constipation  1  26/70 (37.14%)  26 7/39 (17.95%)  7
Vomiting  1  23/70 (32.86%)  23 12/39 (30.77%)  12
Abdominal pain  1  21/70 (30.00%)  21 6/39 (15.38%)  6
Mucosal inflammation  1  12/70 (17.14%)  12 4/39 (10.26%)  4
Abdominal distension  1  10/70 (14.29%)  10 3/39 (7.69%)  3
Dyspepsia  1  9/70 (12.86%)  9 1/39 (2.56%)  1
Gastrointestinal hemorrhage  1  8/70 (11.43%)  8 1/39 (2.56%)  1
Abdominal pain upper  1  7/70 (10.00%)  7 3/39 (7.69%)  3
Ascites  1  6/70 (8.57%)  6 1/39 (2.56%)  1
Flatulence  1  6/70 (8.57%)  6 0/39 (0.00%)  0
Stomatitis  1  5/70 (7.14%)  5 1/39 (2.56%)  1
Gastroesophageal reflux disease  1  4/70 (5.71%)  4 2/39 (5.13%)  2
General disorders     
Fatigue  1  40/70 (57.14%)  40 24/39 (61.54%)  24
Dehydration  1  17/70 (24.29%)  17 6/39 (15.38%)  6
Asthenia  1  9/70 (12.86%)  9 6/39 (15.38%)  6
Chills  1  8/70 (11.43%)  8 4/39 (10.26%)  4
Pyrexia  1  5/70 (7.14%)  5 7/39 (17.95%)  7
Edema  1  4/70 (5.71%)  4 2/39 (5.13%)  2
Pain  1  4/70 (5.71%)  4 3/39 (7.69%)  3
Hepatobiliary disorders     
Jaundice  1  6/70 (8.57%)  6 3/39 (7.69%)  3
Hyperbilirubinemia  1  4/70 (5.71%)  4 3/39 (7.69%)  3
Infections and infestations     
Pneumonia  1  6/70 (8.57%)  6 2/39 (5.13%)  2
Cellulitis  1  5/70 (7.14%)  5 1/39 (2.56%)  1
Upper respiratory tract infection  1  5/70 (7.14%)  5 1/39 (2.56%)  1
Urinary tract infection  1  4/70 (5.71%)  4 7/39 (17.95%)  7
Investigations     
Weight decreased  1  6/70 (8.57%)  6 4/39 (10.26%)  4
Alanine aminotransferase increased  1  5/70 (7.14%)  5 2/39 (5.13%)  2
Liver function test abnormal  1  5/70 (7.14%)  5 1/39 (2.56%)  1
Aspartate aminotransferase increased  1  4/70 (5.71%)  4 2/39 (5.13%)  2
Metabolism and nutrition disorders     
Anorexia  1  18/70 (25.71%)  18 6/39 (15.38%)  6
Hypokalemia  1  10/70 (14.29%)  10 6/39 (15.38%)  6
Decreased appetite  1  4/70 (5.71%)  4 5/39 (12.82%)  5
Hypomagnesemia  1  2/70 (2.86%)  2 6/39 (15.38%)  6
Hyponatremia  1  2/70 (2.86%)  2 6/39 (15.38%)  6
Musculoskeletal and connective tissue disorders     
Edema peripheral  1  21/70 (30.00%)  21 18/39 (46.15%)  18
Back pain  1  7/70 (10.00%)  7 3/39 (7.69%)  3
Nervous system disorders     
Dizziness  1  10/70 (14.29%)  10 5/39 (12.82%)  5
Dysgeusia  1  5/70 (7.14%)  5 4/39 (10.26%)  4
Headache  1  5/70 (7.14%)  5 2/39 (5.13%)  2
Psychiatric disorders     
Insomnia  1  11/70 (15.71%)  11 5/39 (12.82%)  5
Anxiety  1  7/70 (10.00%)  7 3/39 (7.69%)  3
Depression  1  5/70 (7.14%)  5 5/39 (12.82%)  5
Renal and urinary disorders     
Renal failure  1  6/70 (8.57%)  6 0/39 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  22/70 (31.43%)  22 14/39 (35.90%)  14
Cough  1  8/70 (11.43%)  8 5/39 (12.82%)  5
Skin and subcutaneous tissue disorders     
Rash  1  32/70 (45.71%)  32 20/39 (51.28%)  20
Dermatitis Acneiform  1  15/70 (21.43%)  15 2/39 (5.13%)  2
Night sweats  1  7/70 (10.00%)  7 1/39 (2.56%)  1
Alopecia  1  5/70 (7.14%)  5 4/39 (10.26%)  4
Dry skin  1  5/70 (7.14%)  5 2/39 (5.13%)  2
Pruritus  1  5/70 (7.14%)  5 6/39 (15.38%)  6
Erythema  1  4/70 (5.71%)  4 2/39 (5.13%)  2
Vascular disorders     
Deep vein thrombosis  1  8/70 (11.43%)  8 5/39 (12.82%)  5
Epistaxis  1  7/70 (10.00%)  7 4/39 (10.26%)  4
Hypotension  1  7/70 (10.00%)  7 5/39 (12.82%)  5
Pulmonary embolism  1  4/70 (5.71%)  4 4/39 (10.26%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tracy Parrott
Organization: Tragara Pharmaceuticals
Phone: 760-208-6919
EMail: tparrott@tragarapharma.com
Layout table for additonal information
Responsible Party: Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00709826     History of Changes
Other Study ID Numbers: TP2001-203
APRiCOT-P ( Other Identifier: Tragara Pharmaceuticals )
First Submitted: July 1, 2008
First Posted: July 3, 2008
Results First Submitted: June 18, 2012
Results First Posted: November 7, 2012
Last Update Posted: November 7, 2012