Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-S001 | 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
This study will collect further basic safety data on participants with cancer treated with enzastaurin. This study is not open to the public.
The purpose of the this study is to extend the clinical experience of participants who complete enzastaurin therapy per clinical pharmacology and biopharmaceutics studies conducted by Eli Lilly and Company and who may benefit from continued enzastaurin therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzastaurin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin | Drug | 500 milligrams (mg), oral, daily, six 42-day cycle and subsequent cycles or until participants met study discontinuation criteria of progressive disease or unacceptable toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report. | Baseline through study completion (up to 26 months and 30-day safety follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression (Time to Documented Tumor Activity) | Time to disease progression was defined as the time in months from study enrollment to the first date of progressive disease. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease was defined as having at least a 20% increase in sum of the longest diameter of target lesions. Time to disease progression was censored at the date of the last follow-up for participants who did not experience progressive disease, death, or their disease status was unknown. |
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. | Sun City | Arizona | 85351 |
Eligible participants must have completed other enzastaurin clinical pharmacology studies to meet the enrollment criteria for the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enzastaurin | Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants who received at least 1 dose of enzastaurin.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enzastaurin | Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met. |
| 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 | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report. | All enrolled participants who received at least 1 dose of enzastaurin. | Posted | Count of Participants | Participants | No | Baseline through study completion (up to 26 months and 30-day safety follow-up) |
|
Not provided
Study-specific clinical outcomes of death due to disease progression were not reported as serious adverse events (SAEs) unless the investigator deemed them related to the use of study drug.
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 | Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | 12.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C504878 | enzastaurin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline through study completion (up to 26 months and 30-day safety follow-up) |
| Percentage of Participants With Best Overall Response (Documented Antitumor Activity) | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response was defined as the disappearance of all target lesions. Partial Response was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease was defined as having at least a 20% increase in sum of longest diameter of target lesions. Stable Disease was defined as small changes that did not meet the above criteria. Also, reported were unknown and missing responses. Percentage of participants was calculated as the total number of participants affected divided by the number of participants analyzed then multiplied by 100. | Baseline through study completion (up to 26 months and 30-day safety follow-up) |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Disease Stage at Initial Pathological Diagnosis | Disease stage describes how big the tumor is and how far it has spread from the site of origin. Stages ranged from I (cancer is small and hasn't spread to the lymph nodes) to IV (cancer has spread throughout the body). Stage II has localized growth with no metastasis and is further differentiated based on the tumor size by Stage IIA (smaller) to Stage IIC (larger). | Count of Participants | Participants | No |
|
| Initial Pathological Diagnosis | Count of Participants | Participants | No |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status Score | ECOG performance status was used to classify participants according to their functional impairment. Score 0 = fully active, able to carry on all pre-disease performance without restriction. Score 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light house work, office work. Score 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. | Count of Participants | Participants | No |
|
|
|
| Secondary | Time to Disease Progression (Time to Documented Tumor Activity) | Time to disease progression was defined as the time in months from study enrollment to the first date of progressive disease. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease was defined as having at least a 20% increase in sum of the longest diameter of target lesions. Time to disease progression was censored at the date of the last follow-up for participants who did not experience progressive disease, death, or their disease status was unknown. | All enrolled participants who received at least 1 dose of enzastaurin. Two (2) participants were censored. | Posted | Median | 95% Confidence Interval | months | Baseline through study completion (up to 26 months and 30-day safety follow-up) |
|
|
|
| Secondary | Percentage of Participants With Best Overall Response (Documented Antitumor Activity) | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response was defined as the disappearance of all target lesions. Partial Response was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease was defined as having at least a 20% increase in sum of longest diameter of target lesions. Stable Disease was defined as small changes that did not meet the above criteria. Also, reported were unknown and missing responses. Percentage of participants was calculated as the total number of participants affected divided by the number of participants analyzed then multiplied by 100. | All enrolled participants who received at least 1 dose of enzastaurin. | Posted | Number | percentage of participants | Baseline through study completion (up to 26 months and 30-day safety follow-up) |
|
|
|
| 9 |
| 23 |
| 19 |
| 23 |
| Ascites | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Oesophageal haemorrhage | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | 12.0 | Systematic Assessment |
|
| Chest pain | General disorders | 12.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | 12.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | 12.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | 12.0 | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 12.0 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 12.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 12.0 | Systematic Assessment |
|
| Tumor associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 12.0 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | 12.0 | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | 12.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | 12.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | 12.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | 12.0 | Systematic Assessment |
|
| Weight decreased | Investigations | 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
|
Not provided
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Unknown Response |
|
| Missing Response |
|