Trial Outcomes & Findings for 0822GCC: Phase 2 Study of Efficacy and Safety of Apricoxib/Placebo With Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer (NCT NCT00771953)
NCT ID: NCT00771953
Last Updated: 2019-10-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
From the date of randomization until the first date that recurrent or progressive disease is objectively documented.
Results posted on
2019-10-30
Participant Flow
University Medical Centers and Hospital Based Oncology Programs recruited participants from November 2011 through August 2011
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.
Participant milestones
| Measure |
Apricoxib Plus Docetaxel or Pemetrexed
Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
|
Placebo Plus Docetaxel or Pemetrexed
Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
Apricoxib Plus Docetaxel or Pemetrexed
Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
|
Placebo Plus Docetaxel or Pemetrexed
Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Progression before active Tx
|
1
|
2
|
|
Overall Study
Sponsor decision
|
1
|
0
|
|
Overall Study
Other complicating disease
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
0822GCC: Phase 2 Study of Efficacy and Safety of Apricoxib/Placebo With Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Apricoxib Plus Docetaxel or Pemetrexed
n=36 Participants
Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
|
Placebo Plus Docetaxel or Pemetrexed
n=36 Participants
Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
62 years
n=5 Participants
|
66 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization until the first date that recurrent or progressive disease is objectively documented.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.
Outcome measures
| Measure |
Apricoxib Plus Docetaxel
n=17 Participants
Apricoxib 400mg qd plus docetaxel 75mg/m2 q21 days
|
Placebo Plus Docetaxel
n=20 Participants
Placebo plus docetaxel 75mg/m2 q21 days
|
Apricoxib Plus Pemetrexed
n=19 Participants
Apricoxib 400mg qd plus pemetrexed 500mg/m2 q21 days
|
Placebo Plus Pemetrexed
n=16 Participants
Placebo plus pemetrexed 500mg/m2 q21 days
|
|---|---|---|---|---|
|
Progression Free Survival
|
75 days
Interval 47.0 to 104.0
|
97 days
Interval 48.0 to 216.0
|
103 days
Interval 62.0 to 225.0
|
98 days
Interval 37.0 to 197.0
|
Adverse Events
Apricoxib Plus Docetaxel or Pemetrexed
Serious events: 11 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo Plus Docetaxel or Pemetrexed
Serious events: 11 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Apricoxib Plus Docetaxel or Pemetrexed
n=36 participants at risk
Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
|
Placebo Plus Docetaxel or Pemetrexed
n=36 participants at risk
Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Abdominal pain
|
0.00%
0/36
|
5.6%
2/36 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/36
|
5.6%
2/36 • Number of events 3
|
|
Nervous system disorders
Aseptic meningitis
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Cardiac disorders
Atrial flutter
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
General disorders
Chest pain
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Colonic perforation
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
CPOD exacerbation
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Coumadin toxicity
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Hepatobiliary disorders
Creatinine increase
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Dehydration
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
2/36 • Number of events 2
|
0.00%
0/36
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
General disorders
Headache
|
2.8%
1/36 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Hyperkalemia
|
2.8%
1/36 • Number of events 2
|
0.00%
0/36
|
|
General disorders
Hypernatremia
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Hepatobiliary disorders
Hypoglycemia
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
General disorders
Hyponatremia
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
General disorders
Hypoxia
|
2.8%
1/36 • Number of events 1
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Infection
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Infections and infestations
Pneumonia
|
0.00%
0/36
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.8%
1/36 • Number of events 1
|
0.00%
0/36
|
|
Blood and lymphatic system disorders
Thrombosis
|
0.00%
0/36
|
5.6%
2/36 • Number of events 2
|
Other adverse events
| Measure |
Apricoxib Plus Docetaxel or Pemetrexed
n=36 participants at risk
Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
|
Placebo Plus Docetaxel or Pemetrexed
n=36 participants at risk
Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
|
|---|---|---|
|
General disorders
Hyponatremia
|
5.6%
2/36 • Number of events 3
|
0.00%
0/36
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
3/36 • Number of events 3
|
0.00%
0/36
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.8%
1/36 • Number of events 1
|
8.3%
3/36 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
9/36 • Number of events 9
|
25.0%
9/36 • Number of events 10
|
|
Blood and lymphatic system disorders
Lowered WBC count
|
5.6%
2/36 • Number of events 3
|
2.8%
1/36 • Number of events 1
|
Additional Information
Michelle Medeiros
University of Maryland Baltimore Greenebaum Cancer Center
Phone: 410-328-1160
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place