Trial Outcomes & Findings for APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer (NCT NCT00652340)

NCT ID: NCT00652340

Last Updated: 2012-04-09

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

120 participants

Primary outcome timeframe

Baseline and every other cycle.

Results posted on

2012-04-09

Participant Flow

The study opened to accural in April 2008. Enrollment closed in May 2010. One hundred seventy six patients were enrolled with 120 patients randomized. Patients were recruited from clinical oncology practices.

Enrolled patients underwent a 5-day open label treatment with apricoxib to determine the maximum suppression of PGEM from a baseline measurment. PGEM was used as a biomarker of COX-2 activity in the tumor. Patients with at least a 50% decrease on day 5 from their baseline measurment were eligible to be randomized.

Participant milestones

Participant milestones
Measure	Apricoxib/Erlotinib Patients randomized to receive apricoxib and erlotinib.	Placebo/Erlotinib Patients randomized to receive placebo and erlotinib.
Overall Study STARTED	78	42
Overall Study COMPLETED	74	39
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Apricoxib/Erlotinib Patients randomized to receive apricoxib and erlotinib.	Placebo/Erlotinib Patients randomized to receive placebo and erlotinib.
Overall Study Had not progressed.	4	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apricoxib/Erlotinib n=78 Participants Patients randomized to receive apricoxib and erlotinib.	Placebo/Erlotinib n=42 Participants Patients randomized to receive placebo and erlotinib.	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	23 Participants n=7 Participants	69 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants	19 Participants n=7 Participants	51 Participants n=5 Participants
Age Continuous	62.1 years STANDARD_DEVIATION 10.78 • n=5 Participants	64.6 years STANDARD_DEVIATION 11.16 • n=7 Participants	62.9 years STANDARD_DEVIATION 10.94 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	17 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	25 Participants n=7 Participants	67 Participants n=5 Participants
Region of Enrollment United States	78 participants n=5 Participants	42 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and every other cycle.

Population: 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.

Outcome measures

Outcome measures
Measure	Apricoxib/Erlotinib n=78 Participants Patients randomized to receive apricoxib and erlotinib.	Placebo/Erlotinib n=42 Participants Patients randomized to receive placebo and erlotinib.
Time to Disease Progression (TDP)	1.80 months Interval 1.4 to 2.8	2.10 months Interval 1.4 to 4.0

SECONDARY outcome

Timeframe: Randomization and every cycle

Outcome measures

Outcome measures
Measure	Apricoxib/Erlotinib n=78 Participants Patients randomized to receive apricoxib and erlotinib.	Placebo/Erlotinib n=42 Participants Patients randomized to receive placebo and erlotinib.
Overall Survival	5.90 months Interval 4.1 to 8.5	5.60 months Interval 3.8 to 9.1

Adverse Events

Apricoxib/Erlotinib

Serious events: 13 serious events

Other events: 77 other events

Deaths: 0 deaths

Placebo/Erlotinib

Serious events: 4 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Tracy Parrott

Tragara Pharmaceuticals

Phone: 858-350-6919

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Apricoxib/Erlotinib n=78 participants at risk Patients randomized to receive apricoxib and erlotinib.	Placebo/Erlotinib n=42 participants at risk Patients randomized to receive placebo and erlotinib.
Blood and lymphatic system disorders Anemia	1.3% 1/78 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	0.00% 0/42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/78 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	2.4% 1/42 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Cardiac disorders Acute myocardial infarction	1.3% 1/78 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	0.00% 0/42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Cardiac disorders Left ventricular dysfunction	1.3% 1/78 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	0.00% 0/42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Cardiac disorders Myocardial infarction	0.00% 0/78 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	2.4% 1/42 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Gastrointestinal disorders Diarrhea	2.6% 2/78 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	0.00% 0/42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Gastrointestinal disorders Gastric ulcer perforation	1.3% 1/78 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	0.00% 0/42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Gastrointestinal disorders Gastrointestinal hemorrhage	1.3% 1/78 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	2.4% 1/42 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Gastrointestinal disorders Intestinal perforation	1.3% 1/78 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	0.00% 0/42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Gastrointestinal disorders Peritonitis	1.3% 1/78 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	0.00% 0/42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/78 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	2.4% 1/42 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Investigations Blood creatinine increased	1.3% 1/78 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	0.00% 0/42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Nervous system disorders Cerebral infarction	1.3% 1/78 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	0.00% 0/42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Nervous system disorders Cerebrovascular accident	1.3% 1/78 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	0.00% 0/42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Renal and urinary disorders Renal failure acute	1.3% 1/78 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	0.00% 0/42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.00% 0/78 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	2.4% 1/42 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	1.3% 1/78 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	0.00% 0/42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.

Measure	Apricoxib/Erlotinib n=78 participants at risk Patients randomized to receive apricoxib and erlotinib.	Placebo/Erlotinib n=42 participants at risk Patients randomized to receive placebo and erlotinib.
Skin and subcutaneous tissue disorders Rash	53.8% 42/78 • Number of events 42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	54.8% 23/42 • Number of events 23 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Gastrointestinal disorders Diarrhea	52.6% 41/78 • Number of events 41 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	59.5% 25/42 • Number of events 25 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
General disorders fatigue	42.3% 33/78 • Number of events 33 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	28.6% 12/42 • Number of events 12 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Gastrointestinal disorders Nausea	34.6% 27/78 • Number of events 27 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	28.6% 12/42 • Number of events 12 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Skin and subcutaneous tissue disorders Dry skin	25.6% 20/78 • Number of events 20 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	26.2% 11/42 • Number of events 11 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Respiratory, thoracic and mediastinal disorders Cough	23.1% 18/78 • Number of events 18 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	11.9% 5/42 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
General disorders Anorexia	21.8% 17/78 • Number of events 17 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	35.7% 15/42 • Number of events 15 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.5% 16/78 • Number of events 16 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	26.2% 11/42 • Number of events 11 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Gastrointestinal disorders Vomiting	20.5% 16/78 • Number of events 16 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	9.5% 4/42 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Gastrointestinal disorders Mucosal inflammation	19.2% 15/78 • Number of events 15 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	9.5% 4/42 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Skin and subcutaneous tissue disorders Dermatitis acneiform	16.7% 13/78 • Number of events 13 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	26.2% 11/42 • Number of events 11 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Gastrointestinal disorders Constipation	15.4% 12/78 • Number of events 12 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	11.9% 5/42 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Psychiatric disorders Insomnia	14.1% 11/78 • Number of events 11 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	16.7% 7/42 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Nervous system disorders Dizziness	12.8% 10/78 • Number of events 10 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	9.5% 4/42 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Gastrointestinal disorders Dyspepsia	12.8% 10/78 • Number of events 10 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	14.3% 6/42 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Skin and subcutaneous tissue disorders Pruritis	12.8% 10/78 • Number of events 10 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	21.4% 9/42 • Number of events 9 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Blood and lymphatic system disorders Anemia	11.5% 9/78 • Number of events 9 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	4.8% 2/42 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Investigations Blood creatinine increased	11.5% 9/78 • Number of events 9 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	0.00% 0/42 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
General disorders Weight decreased	11.5% 9/78 • Number of events 9 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	14.3% 6/42 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Musculoskeletal and connective tissue disorders Edema peripheral	10.3% 8/78 • Number of events 8 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	14.3% 6/42 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Psychiatric disorders Anxiety	9.0% 7/78 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	2.4% 1/42 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Musculoskeletal and connective tissue disorders Back pain	9.0% 7/78 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	11.9% 5/42 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
General disorders Dehydration	9.0% 7/78 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	7.1% 3/42 • Number of events 3 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Skin and subcutaneous tissue disorders Epistaxis	9.0% 7/78 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	2.4% 1/42 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Infections and infestations Pneumonia	9.0% 7/78 • Number of events 7 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	9.5% 4/42 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Skin and subcutaneous tissue disorders Alopecia	7.7% 6/78 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	9.5% 4/42 • Number of events 4 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Psychiatric disorders Depression	7.7% 6/78 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	4.8% 2/42 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Respiratory, thoracic and mediastinal disorders Wheezing	7.7% 6/78 • Number of events 6 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	2.4% 1/42 • Number of events 1 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Gastrointestinal disorders Abdominal pain	6.4% 5/78 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	11.9% 5/42 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Gastrointestinal disorders Dysgeusia	6.4% 5/78 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	7.1% 3/42 • Number of events 3 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Respiratory, thoracic and mediastinal disorders Hemoptysis	6.4% 5/78 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	4.8% 2/42 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.
Cardiac disorders Hypertension	6.4% 5/78 • Number of events 5 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.	4.8% 2/42 • Number of events 2 • First dose of study drug to 30 days after last dose of study drug. Only drug related serious adverse events are listed.