APRiCOT-P: Study of Apricoxib With Gemcitabine and Erloti... | NCT00709826

ID	Type	Description	Link
APRiCOT-P	Other Identifier	Tragara Pharmaceuticals

Label	Type	Description	Intervention Names
apricoxib + gemcitabine + erlotinib	Experimental	400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib	Drug: gemcitabine Drug: Erlotinib Drug: apricoxib
placebo + gemcitabine + erlotinib	Placebo Comparator	placebo + 1000mg/m2 gemcitabine + 100mg erlotinib	Drug: gemcitabine Drug: placebo Drug: Erlotinib

Name	Type	Description	Arm Group Labels	Other Names
gemcitabine	Drug	Gemcitabine: per package insert.	apricoxib + gemcitabine + erlotinib placebo + gemcitabine + erlotinib

Measure	Description	Time Frame
Progression Free Survival	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.	Randomization then every other cycle

Measure	Description	Time Frame
Overall Survival		Randomization then every other cycle

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic.
Life expectancy greater than or equal to 3 months.
Patients must have measurable disease by RECIST.
ECOG PS of 0, 1, or 2.
Negative serum pregnancy test at the time of first dose for women of childbearing potential.

Exclusion Criteria:

Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4).
RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment.
Evidence of New York Heart Association class III or greater cardiac disease.
History of myocardial infarction, stroke, ventricular arrhythmia.
Symptomatic central nervous system metastases.
Pregnant or nursing women.
Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
History of upper gastrointestinal bleeding, ulceration or perforation. History of lower GI bleeding, ulceration, or perforation within 12 months.
Previous anti-EGFR kinase therapy.

Name	Affiliation	Role
Tracy Parrott	Tragara Pharmaceuticals, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Clinical Research Center		Tucson	Arizona	85715	United States
Comprehensive Blood and Cancer Center

ID	Title	Description
FG000	Apricoxib/Gemcitabine/Erlotinib	Patients randomized to receive apricoxib + gemcitabine + erlotinib.
FG001	Placebo/Gemcitabine/Erlotinib	Patients randomized to receive placebo + gemcitabine + erlotinib.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

Overall Survival

Posted

Median

95% Confidence Interval

Months

Randomization then every other cycle

ID	Title	Description
OG000	Apricoxib/Gemcitabine/Erlotinib	Patients randomized to receive apricoxib + gemcitabine + erlotinib.
OG001	Placebo/Gemcitabine/Erlotinib	Patients randomized to receive placebo + gemcitabine + erlotinib.

Units	Counts
Participants	OG00070 OG00139

Title

Denominators

Categories

Title	Measurements
	OG0005.0(3.67 to 50.47) OG0014.8(4.07 to 5.70)

Primary

Progression Free Survival

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.

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.

Posted

Median

95% Confidence Interval

Months

Randomization then every other cycle

ID	Title	Description
OG000	Apricoxib/Gemcitabine/Erlotinib	Patients randomized to receive apricoxib + gemcitabine + erlotinib.
OG001	Placebo/Gemcitabine/Erlotinib	Patients randomized to receive placebo + gemcitabine + erlotinib.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0010 events0 affected39 at risk
Myocardial infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected70 at risk EG0011 events1 affected39 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0010 events0 affected39 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected70 at risk EG0010 events0 affected39 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0010 events0 affected39 at risk
Esophagitis ulcerative	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0010 events0 affected39 at risk
Ulcer	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0010 events0 affected39 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0011 events1 affected39 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0010 events0 affected39 at risk
Sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0010 events0 affected39 at risk
International normalized ratio increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0010 events0 affected39 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0010 events0 affected39 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected70 at risk EG0011 events1 affected39 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected70 at risk EG0011 events1 affected39 at risk
Renal failure	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0010 events0 affected39 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0010 events0 affected39 at risk
Cerebrovascular accident	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0010 events0 affected39 at risk
Embolic stroke	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 events0 affected70 at risk EG0011 events1 affected39 at risk
Pulmonary embolism	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 events1 affected70 at risk EG0010 events0 affected39 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00041 events41 affected70 at risk EG00117 events17 affected39 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00041 events41 affected70 at risk EG00115 events15 affected39 at risk
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG00040 events40 affected70 at risk EG00124 events24 affected39 at risk
Anemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00037 events37 affected70 at risk EG00118 events18 affected39 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00032 events32 affected70 at risk EG00120 events20 affected39 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00029 events29 affected70 at risk EG00114 events14 affected39 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00026 events26 affected70 at risk EG0017 events7 affected39 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00023 events23 affected70 at risk EG00112 events12 affected39 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00022 events22 affected70 at risk EG00114 events14 affected39 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00021 events21 affected70 at risk EG0016 events6 affected39 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00021 events21 affected70 at risk EG00113 events13 affected39 at risk
Edema peripheral	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00021 events21 affected70 at risk EG00118 events18 affected39 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00018 events18 affected70 at risk EG0016 events6 affected39 at risk
Dehydration	General disorders	MedDRA (10.0)	Systematic Assessment	EG00017 events17 affected70 at risk EG0016 events6 affected39 at risk
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00015 events15 affected70 at risk EG0012 events2 affected39 at risk
Mucosal inflammation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00012 events12 affected70 at risk EG0014 events4 affected39 at risk
Insomnia	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG00011 events11 affected70 at risk EG0015 events5 affected39 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00010 events10 affected70 at risk EG0013 events3 affected39 at risk
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00010 events10 affected70 at risk EG0015 events5 affected39 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00010 events10 affected70 at risk EG0016 events6 affected39 at risk
Asthenia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0009 events9 affected70 at risk EG0016 events6 affected39 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0009 events9 affected70 at risk EG0011 events1 affected39 at risk
Chills	General disorders	MedDRA (10.0)	Systematic Assessment	EG0008 events8 affected70 at risk EG0014 events4 affected39 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0008 events8 affected70 at risk EG0015 events5 affected39 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0008 events8 affected70 at risk EG0015 events5 affected39 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0008 events8 affected70 at risk EG0011 events1 affected39 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events7 affected70 at risk EG0013 events3 affected39 at risk
Anxiety	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events7 affected70 at risk EG0013 events3 affected39 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events7 affected70 at risk EG0013 events3 affected39 at risk
Epistaxis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events7 affected70 at risk EG0014 events4 affected39 at risk
Hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events7 affected70 at risk EG0015 events5 affected39 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0007 events7 affected70 at risk EG0011 events1 affected39 at risk
Ascites	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0006 events6 affected70 at risk EG0011 events1 affected39 at risk
Flatulence	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0006 events6 affected70 at risk EG0010 events0 affected39 at risk
Jaundice	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0006 events6 affected70 at risk EG0013 events3 affected39 at risk
Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0006 events6 affected70 at risk EG0012 events2 affected39 at risk
Renal failure	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0006 events6 affected70 at risk EG0010 events0 affected39 at risk
Weight decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0006 events6 affected70 at risk EG0014 events4 affected39 at risk
Alanine aminotransferase increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected70 at risk EG0012 events2 affected39 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected70 at risk EG0014 events4 affected39 at risk
Cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected70 at risk EG0011 events1 affected39 at risk
Depression	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected70 at risk EG0015 events5 affected39 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected70 at risk EG0012 events2 affected39 at risk
Dysgeusia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected70 at risk EG0014 events4 affected39 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected70 at risk EG0012 events2 affected39 at risk
Liver function test abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected70 at risk EG0011 events1 affected39 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected70 at risk EG0016 events6 affected39 at risk
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected70 at risk EG0017 events7 affected39 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected70 at risk EG0011 events1 affected39 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0005 events5 affected70 at risk EG0011 events1 affected39 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected70 at risk EG0012 events2 affected39 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected70 at risk EG0015 events5 affected39 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected70 at risk EG0012 events2 affected39 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected70 at risk EG0012 events2 affected39 at risk
Hyperbilirubinemia	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected70 at risk EG0013 events3 affected39 at risk
Edema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected70 at risk EG0012 events2 affected39 at risk
Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected70 at risk EG0013 events3 affected39 at risk
Pulmonary embolism	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected70 at risk EG0014 events4 affected39 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0004 events4 affected70 at risk EG0017 events7 affected39 at risk
Hypomagnesemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected70 at risk EG0016 events6 affected39 at risk
Hyponatremia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0002 events2 affected70 at risk EG0016 events6 affected39 at risk

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	Apricoxib/Gemcitabine/Erlotinib	Patients randomized to receive apricoxib + gemcitabine + erlotinib.
BG001	Placebo/Gemcitabine/Erlotinib	Patients randomized to receive placebo + gemcitabine + erlotinib.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Apricoxib/Gemcitabine/Erlotinib	Patients randomized to receive apricoxib + gemcitabine + erlotinib.			16	70	70	70
EG001	Placebo/Gemcitabine/Erlotinib	Patients randomized to receive placebo + gemcitabine + erlotinib.			5	39	39	39

ID	Term
D000093542	Gemcitabine
D000069347	Erlotinib Hydrochloride
C514354	apricoxib