Trial Outcomes & Findings for A Trial of Placebo Versus Enzastaurin for Lung Cancer Prevention in Former Smokers (NCT NCT00414960)
NCT ID: NCT00414960
Last Updated: 2020-09-21
Results Overview
The number of cells positively stained for Ki-67 (a marker of cellular proliferation) was enumerated and divided by the total number of cells in each specimen. The average Ki-67 labeling index (LI) (percentage of cells positively labeled with Ki-67) for all histological specimens was then calculated for each participant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Baseline, endpoint (up to 8 months)
Results posted on
2020-09-21
Participant Flow
Participant milestones
| Measure |
Enzastaurin
Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each).
|
Placebo
Treatment with placebo po QD appearing identical to enzastaurin.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
15
|
|
Overall Study
Received at Least One Dose of Study Drug
|
24
|
15
|
|
Overall Study
COMPLETED
|
18
|
14
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
Enzastaurin
Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each).
|
Placebo
Treatment with placebo po QD appearing identical to enzastaurin.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Trial of Placebo Versus Enzastaurin for Lung Cancer Prevention in Former Smokers
Baseline characteristics by cohort
| Measure |
Enzastaurin
n=25 Participants
Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each).
|
Placebo
n=15 Participants
Treatment with placebo po QD appearing identical to enzastaurin.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.84 years
STANDARD_DEVIATION 6.06 • n=5 Participants
|
66.97 years
STANDARD_DEVIATION 4.67 • n=7 Participants
|
66.89 years
STANDARD_DEVIATION 5.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
24 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Evidence of Airway Obstruction
Absence
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Evidence of Airway Obstruction
Presence
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
Grade 0
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
Grade 1
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
History of Stage I Non-small Cell Lung Cancer
Yes
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
History of Stage I Non-small Cell Lung Cancer
No
|
24 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, endpoint (up to 8 months)Population: The number of participants analyzed was based on the efficacy population (EP). The EP included participants who met study criteria, were randomized to the study, and who had Ki-67 measurements from biopsy specimens.
The number of cells positively stained for Ki-67 (a marker of cellular proliferation) was enumerated and divided by the total number of cells in each specimen. The average Ki-67 labeling index (LI) (percentage of cells positively labeled with Ki-67) for all histological specimens was then calculated for each participant.
Outcome measures
| Measure |
Enzastaurin
n=21 Participants
Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each).
|
Placebo
n=13 Participants
Treatment with placebo po QD appearing identical to enzastaurin.
|
|---|---|---|
|
Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint
|
3.74 percentage of cells with Ki-67
Standard Deviation 11.68
|
6.15 percentage of cells with Ki-67
Standard Deviation 11.08
|
SECONDARY outcome
Timeframe: Baseline through end of study (up to 32 months)Population: The number of participants analyzed was based on the safety population (SP). The SP included participants who received at least 1 dose of enzastaurin or placebo during the study.
Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.
Outcome measures
| Measure |
Enzastaurin
n=24 Participants
Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each).
|
Placebo
n=15 Participants
Treatment with placebo po QD appearing identical to enzastaurin.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
SAEs
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Other Non-Serious AEs
|
24 Participants
|
10 Participants
|
Adverse Events
Enzastaurin
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enzastaurin
n=24 participants at risk
Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each).
|
Placebo
n=15 participants at risk
Treatment with placebo po QD appearing identical to enzastaurin.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
4.2%
1/24 • Number of events 1
|
0.00%
0/15
|
|
Vascular disorders
Deep vein thrombosis
|
4.2%
1/24 • Number of events 1
|
0.00%
0/15
|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • Number of events 1
|
0.00%
0/15
|
Other adverse events
| Measure |
Enzastaurin
n=24 participants at risk
Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each).
|
Placebo
n=15 participants at risk
Treatment with placebo po QD appearing identical to enzastaurin.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
8.3%
2/24 • Number of events 2
|
0.00%
0/15
|
|
Cardiac disorders
Supraventricular extrasystoles
|
8.3%
2/24 • Number of events 3
|
0.00%
0/15
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
2/24 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
4/24 • Number of events 4
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
2/24 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
1/24 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Fatigue
|
4.2%
1/24 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Local swelling
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Oedema peripheral
|
8.3%
2/24 • Number of events 2
|
0.00%
0/15
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
2/24 • Number of events 3
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
4.2%
1/24 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/24
|
6.7%
1/15 • Number of events 3
|
|
Investigations
Blood creatinine increased
|
8.3%
2/24 • Number of events 2
|
0.00%
0/15
|
|
Investigations
Electrocardiogram QT prolonged
|
12.5%
3/24 • Number of events 5
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
25.0%
6/24 • Number of events 7
|
0.00%
0/15
|
|
Investigations
Haemoglobin increased
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Urine colour abnormal
|
16.7%
4/24 • Number of events 4
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
8.3%
2/24 • Number of events 2
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.8%
5/24 • Number of events 5
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
8/24 • Number of events 13
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
8.3%
2/24 • Number of events 2
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
6/24 • Number of events 9
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Number of events 2
|
0.00%
0/15
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
Chromaturia
|
8.3%
2/24 • Number of events 2
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Number of events 2
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
2/24 • Number of events 2
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/24
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
2/24 • Number of events 3
|
0.00%
0/15
|
|
Vascular disorders
Hypertension
|
4.2%
1/24 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60