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| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-JCAR | Other Identifier | Eli Lilly and Company |
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Enzastaurin given daily to participants with colorectal cancer who have Stage 4 disease and have not received prior chemotherapy for advanced colorectal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzastaurin HCl | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzastaurin HCl | Drug | 1200 milligrams (mg) loading dose orally, then 500 mg, orally, daily, up to six 28-day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Progression Free Survival (PFS) at 6 Months | PFS defined as time from date of first dose of enzastaurin to first date of documented progressive disease (PD) or date of death (any cause), whichever occurred first. Using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) PD defined as ≥20% increase in sum of the longest diameter (LD) of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of ≥1 new lesions. Participants not known to have died as of data-inclusion cut-off date and who did not have PD, PFS was censored at date of last progression-free disease assessment prior to date of any post discontinuation anticancer therapy. Participants who took any subsequent systemic anticancer therapy prior to PD or death, PFS was censored at date of last progression-free disease assessment prior to the date of any post discontinuation anticancer therapy. PFS at 6 months = participants who were progression free and alive at 6 months divided by the number of treated participants x 100. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Objective response rate during treatment was defined as the number of participants with documented complete response (CR) or partial response (PR) divided by the total number of participants. CR and PR defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels in non-target lesions. PR defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Percentage of participants with CR or PR (ORR) was the number of participants with documented CR or PR divided by the total number of treated participants x 100. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Vascular Endothelial Growth Factor (VEGF) to Cycle 2 and Cycle 3 | VEGF levels were measured to detect potentially rapid-growing tumors in participants who received enzastaurin. | Baseline, Cycle 2 and Cycle 3 (28-day cycles) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 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. | Odense | 5000 |
Participant flow reports those who discontinued from study drug.
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Enzastaurin HCl | 1200 milligrams (mg) administered orally as a loading dose then 500 mg administered orally, once daily, for up to six 28-day cycles. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enzastaurin HCl | 1200 milligrams (mg) administered orally as a loading dose, then 500 mg administered orally, once daily, for up to six 28-day cycles. |
| 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 | Percentage of Participants With Progression Free Survival (PFS) at 6 Months | PFS defined as time from date of first dose of enzastaurin to first date of documented progressive disease (PD) or date of death (any cause), whichever occurred first. Using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) PD defined as ≥20% increase in sum of the longest diameter (LD) of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of ≥1 new lesions. Participants not known to have died as of data-inclusion cut-off date and who did not have PD, PFS was censored at date of last progression-free disease assessment prior to date of any post discontinuation anticancer therapy. Participants who took any subsequent systemic anticancer therapy prior to PD or death, PFS was censored at date of last progression-free disease assessment prior to the date of any post discontinuation anticancer therapy. PFS at 6 months = participants who were progression free and alive at 6 months divided by the number of treated participants x 100. | All randomized participants who received at least 1 dose of study drug. Censored participants =5 | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to 6 months |
Not provided
Study-specific clinical outcomes due to progressive disease were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the 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 HCl | 1200 milligrams (mg) of enzastaurin HCl administered orally as a loading dose then 500 mg, administered orally once daily up to six 28-day cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 16.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
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| ID | Term |
|---|---|
| C504878 | enzastaurin |
Not provided
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| Baseline to measured progressive disease (PD) up to 24 months |
| Overall Survival (OS) | OS was defined as the time from the date of the first dose of enzastaurin to the date of death from any cause. Survival time was censored at the date of the last contact for participants who were still alive. | Baseline to date of death from any cause up to 24 months |
| Progression Free Survival (PFS) | PFS was defined as the time from the date of the first dose of enzastaurin to the first date of documented progressive disease (PD) or the date of death from any cause, whichever occurred first. Participants who were not known to have died as of the data-inclusion cut-off date, and who did not have PD, PFS was censored at the date of the last progression-free disease assessment date prior to the date of any post discontinuation anticancer therapy. Participants who took any subsequent systemic anticancer therapy prior to PD or death, PFS was censored at the date of the last progression-free disease assessment prior to the date of any post discontinuation anticancer therapy. | Baseline to measured PD up to 9 months |
| Duration of Stable Disease (SD) | Duration of SD measured from date of first dose of enzastaurin to date of documented progressive disease (PD) or date of death from any cause, whichever occurred first, using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). PD was defined as ≥20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD since treatment began or appearance of ≥1 new lesions. SD was defined as no improvement and not meeting the requirements of PD using smallest sum LD since treatment began as reference. Participants with SD (or better) who had not died at data-inclusion cut-off date without PD, or participants who took subsequent systemic anticancer therapy prior to PD or death, duration was censored at date of last progression-free disease assessment prior to the date of post discontinuation anticancer therapy. | Time from SD to measured PD up to 9 months |
| Time to Treatment Response | Time to treatment response was defined as date of first dose of study drug to the date of confirmed complete response (CR) or partial response (PR) using Response evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels in non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Time to treatment response was not evaluable, as there were no participants with CR or PR. | Baseline to date of confirmed response up to 24 months |
| Duration of Complete Response (CR) or Partial Response (PR) (Duration of Response) | The duration CR or PR was defined as the time from first objective status assessment of CR or PR to the first date of documented progressive disease (PD) or death from any cause. CR and PR were determined using Response evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels in non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. PD defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Duration of response was not evaluable, as there were no participants with CR or PR. | Time from response to PD |
| Number of Participants With Adverse Events (AEs) or Who Died | Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious adverse events (AEs) regardless of causality is located in the Reported Adverse Events module. The number of participants who died included those who died due to an SAE (any cause) while on study and those who died due to progressive disease (PD) during the 30-day post-study discontinuation follow-up. | Baseline to study completion up to 24 months and 30-day post-study discontinuation |
| Change From Baseline in QTc Interval | QTc interval was a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A QTc interval adjusted using Bazette's correction (QTcB) was used in order to aid interpretation. | Baseline, Cycle 1 Day 1 and Cycle 2 Day 1 of 28-day cycles |
| Pharmacokinetics-Minimum Observed Concentration (Cmin) of Total Analytes | Cmin of enzastaurin + LSN326020 (a metabolite of LY317615) after loading dose in Cycle 1 and at a steady state during Cycles 2 and 3. | Cycle 1 Day 2-predose, Cycle 2 Day 1-predose and Cycle 3 Day 1-predose of 28-day cycles |
| Change From Baseline in Carcinoembryonic Antigen (CEA) Response at Each Cycle | CEA levels were measured to detect potentially rapid-growing tumors in participants who received enzastaurin. | Baseline and Cycles 1, 2, 3, 4, 5, 6 (28-day cycles) |
| Denmark |
| 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. | Vejle | 7100 | Denmark |
| 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. | Uppsala | 75185 | Sweden |
| Death |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Eastern Cooperative Oncology Group (ECOG) | ECOG performance status: 0 - Fully active, able to carry on all pre-disease performance without restriction. 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. | Count of Participants | Participants | No |
|
| Pathological Diagnosis | Pathological diagnosis at baseline. | Count of Participants | Participants | No |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Enzastaurin HCl | 1200 milligrams (mg) administered orally as a loading dose, then 500 mg administered orally, once daily, for up to six 28-day cycles. |
|
|
| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Objective response rate during treatment was defined as the number of participants with documented complete response (CR) or partial response (PR) divided by the total number of participants. CR and PR defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels in non-target lesions. PR defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Percentage of participants with CR or PR (ORR) was the number of participants with documented CR or PR divided by the total number of treated participants x 100. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to measured progressive disease (PD) up to 24 months |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of the first dose of enzastaurin to the date of death from any cause. Survival time was censored at the date of the last contact for participants who were still alive. | All randomized participants who received at least 1 dose of study drug. Censored participants =23. | Posted | Median | 95% Confidence Interval | months | Baseline to date of death from any cause up to 24 months |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from the date of the first dose of enzastaurin to the first date of documented progressive disease (PD) or the date of death from any cause, whichever occurred first. Participants who were not known to have died as of the data-inclusion cut-off date, and who did not have PD, PFS was censored at the date of the last progression-free disease assessment date prior to the date of any post discontinuation anticancer therapy. Participants who took any subsequent systemic anticancer therapy prior to PD or death, PFS was censored at the date of the last progression-free disease assessment prior to the date of any post discontinuation anticancer therapy. | All randomized participants who received at least 1 dose of study drug. Censored participants =5. | Posted | Median | 95% Confidence Interval | months | Baseline to measured PD up to 9 months |
|
|
|
| Secondary | Duration of Stable Disease (SD) | Duration of SD measured from date of first dose of enzastaurin to date of documented progressive disease (PD) or date of death from any cause, whichever occurred first, using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). PD was defined as ≥20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD since treatment began or appearance of ≥1 new lesions. SD was defined as no improvement and not meeting the requirements of PD using smallest sum LD since treatment began as reference. Participants with SD (or better) who had not died at data-inclusion cut-off date without PD, or participants who took subsequent systemic anticancer therapy prior to PD or death, duration was censored at date of last progression-free disease assessment prior to the date of post discontinuation anticancer therapy. | Subset of all randomized participants who received at least 1 dose of study drug who achieved complete response (CR), partial response (PR) or SD. Censored participants =5. | Posted | Median | 95% Confidence Interval | months | Time from SD to measured PD up to 9 months |
|
|
|
| Secondary | Time to Treatment Response | Time to treatment response was defined as date of first dose of study drug to the date of confirmed complete response (CR) or partial response (PR) using Response evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels in non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Time to treatment response was not evaluable, as there were no participants with CR or PR. | Zero participants were analyzed. | Posted | Baseline to date of confirmed response up to 24 months |
|
|
| Secondary | Duration of Complete Response (CR) or Partial Response (PR) (Duration of Response) | The duration CR or PR was defined as the time from first objective status assessment of CR or PR to the first date of documented progressive disease (PD) or death from any cause. CR and PR were determined using Response evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels in non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. PD defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Duration of response was not evaluable, as there were no participants with CR or PR. | Zero participants were analyzed. | Posted | Time from response to PD |
|
|
| Secondary | Number of Participants With Adverse Events (AEs) or Who Died | Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious adverse events (AEs) regardless of causality is located in the Reported Adverse Events module. The number of participants who died included those who died due to an SAE (any cause) while on study and those who died due to progressive disease (PD) during the 30-day post-study discontinuation follow-up. | All randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline to study completion up to 24 months and 30-day post-study discontinuation |
|
|
|
| Secondary | Change From Baseline in QTc Interval | QTc interval was a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A QTc interval adjusted using Bazette's correction (QTcB) was used in order to aid interpretation. | All randomized participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | milliseconds (msec) | Baseline, Cycle 1 Day 1 and Cycle 2 Day 1 of 28-day cycles |
|
|
|
| Secondary | Pharmacokinetics-Minimum Observed Concentration (Cmin) of Total Analytes | Cmin of enzastaurin + LSN326020 (a metabolite of LY317615) after loading dose in Cycle 1 and at a steady state during Cycles 2 and 3. | All randomized participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | nanomoles per liter (nmol/L) | Cycle 1 Day 2-predose, Cycle 2 Day 1-predose and Cycle 3 Day 1-predose of 28-day cycles |
|
|
|
| Secondary | Change From Baseline in Carcinoembryonic Antigen (CEA) Response at Each Cycle | CEA levels were measured to detect potentially rapid-growing tumors in participants who received enzastaurin. | All participants with both baseline and post baseline CEA measurements. | Posted | Median | Inter-Quartile Range | micrograms per liter (mcg/L) | Baseline and Cycles 1, 2, 3, 4, 5, 6 (28-day cycles) |
|
|
|
| Other Pre-specified | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) to Cycle 2 and Cycle 3 | VEGF levels were measured to detect potentially rapid-growing tumors in participants who received enzastaurin. | Participants with both baseline and post-baseline VEGF measurements. | Posted | Median | Inter-Quartile Range | picograms per liter (pg/L) | Baseline, Cycle 2 and Cycle 3 (28-day cycles) |
|
|
|
| 4 |
| 28 |
| 22 |
| 28 |
| Cardiac failure | Cardiac disorders | 16.0 | Systematic Assessment |
|
| Gastrointestinal obstruction | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Infection | Infections and infestations | 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 16.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Chills | General disorders | 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | 16.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | 16.0 | Systematic Assessment |
|
| Blood urea | Investigations | 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
Not provided
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| Title | Measurements |
|---|---|
|
| Died due to SAE while on study |
|
|
| Cycle 3 Day 1 |
|
|
|
| Cycle 3 |
|
|
| Cycle 4 |
|
|
| Cycle 5 |
|
|
| Cycle 6 |
|
|
|