| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-S009 | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the difference of a marker of cellular proliferation in all bronchial biopsy specimens of former smokers stratified by lung cancer risk, collected before and after treatment per patient between the enzastaurin and placebo groups.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzastaurin | Experimental | Treatment with enzastaurin 500 milligrams (mg) orally (po) once daily (QD) given as 4 tablets (125 mg each). |
|
| Placebo | Placebo Comparator | Treatment with placebo po QD appearing identical to enzastaurin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzastaurin | Drug | 500 mg po QD for 6 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint | 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. | Baseline, endpoint (up to 8 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. | Baseline through end of study (up to 32 months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tampa | Florida | 33612 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enzastaurin | Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each). |
| FG001 | Placebo | Treatment with placebo po QD appearing identical to enzastaurin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enzastaurin | Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each). |
| BG001 | Placebo | Treatment with placebo po QD appearing identical to enzastaurin. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Percentage of Cells Staining Positive for Ki-67 in All Biopsy Specimens at Endpoint | 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. | 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. | Posted | Mean | Standard Deviation | percentage of cells with Ki-67 | Baseline, endpoint (up to 8 months) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enzastaurin | Treatment with enzastaurin 500 milligrams (mg) orally (po), once daily (QD) given as 4 tablets (125 mg each). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
The planned enrollment for the study was 186 participants, but enrollment was terminated early due to the difficulty of accruing participants once 40 were enrolled into the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C504878 | enzastaurin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | po QD for 6 months |
|
| United States |
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Evidence of Airway Obstruction | Evidence of airway obstruction present if Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC ratio) ≤0.7; evidence of airway obstruction absent if FEV1/FVC ratio >0.7. | Count of Participants | Participants | No |
|
| Eastern Cooperative Oncology Group (ECOG) | Measure of performance status as defined by ECOG on a scale of Grade 0 to Grade 5: 0=Fully active, able to carry on pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light and sedentary work; 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead. | Count of Participants | Participants | No |
|
| History of Stage I Non-small Cell Lung Cancer | Participants were asked if they have a history of Stage 1 (cancer is small and has not spread to the lymph nodes) Non-small Cell Lung Cancer. | Count of Participants | Participants | No |
|
| OG001 | Placebo | Treatment with placebo po QD appearing identical to enzastaurin. |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) | Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. | 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. | Posted | Count of Participants | Participants | No | Baseline through end of study (up to 32 months) |
|
|
|
| 2 |
| 24 |
| 24 |
| 24 |
| EG001 | Placebo | Treatment with placebo po QD appearing identical to enzastaurin. | 0 | 15 | 10 | 15 |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Conduction disorder | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Haemoglobin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Urine colour abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |