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| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-S035 | Other Identifier | Eli Lilly and Company |
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Lack of efficacy
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The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine + Enzastaurin | Experimental |
| |
| Capecitabine + Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin | Drug | 1125 milligrams (mg) loading dose then 500 mg, oral, daily, 21-day cycles until progressive disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy. | Randomization to measured progressive disease or death up to 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Expression of Tumor Markers in Tissue Samples (Tumor Markers and Genes Evaluation) | Protein expression was planned to be measured using an Immunohistochemistry (IHC) assay to determine membrane and cytoplasmic phosphorylated glycogen synthase kinase 3 beta (pGSK3B), nuclear phosphorylated adenosine 3'5'-cyclic monophosphate (cAMP) response-element binding protein (pCREB), cytoplasmic pCREB, protein kinase C beta 2 (PKCB2), cytoplasmic phospho S6 (pS6), and cytoplasmic phosphatase and tensin homolog (PTEN) IHC H-scores. Tumor tissue samples were to be scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining, and H- scores calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+) . |
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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 - 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. | Buenos Aires | 1430 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20814815 | Derived | Clemons M, Joy AA, Abdulnabi R, Kotliar M, Lynch J, Jordaan JP, Iscoe N, Gelmon K. Phase II, double-blind, randomized trial of capecitabine plus enzastaurin versus capecitabine plus placebo in patients with metastatic or recurrent breast cancer after prior anthracycline and taxane therapy. Breast Cancer Res Treat. 2010 Nov;124(1):177-86. doi: 10.1007/s10549-010-1152-0. Epub 2010 Sep 3. |
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Participant flow reports those participants who discontinued from study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Capecitabine + Enzastaurin | Capecitabine: 1250 milligrams per square meter (mg/m^2), twice daily (BID) on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease. Enzastaurin: 1125-milligram (mg) loading dose on Day 1 of Cycle 1, then 500 mg daily on subsequent days to complete 21-day cycles until progressive disease. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| placebo | Drug | oral, daily, 21-day cycles until progressive disease |
|
| capecitabine | Drug | 1250 mg/m^2, BID, days 1-14 of each 21-day cycle until progressive disease |
|
| Randomization, Cycle 2, end of study |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State | Area Under the Concentration versus time curve during 1 dosing interval at steady state (AUCτ,ss) for Cycle 2 Day 1 for Enzastaurin, its metabolite LY326020 and total analytes (enzastaurin + LY326020). AUCτ,ss was calculated using concentration versus time data by post hoc estimation of enzastaurin, its metabolite LY326020, and total analytes (enzastaurin + LY326020). | From pre-dose to 24 hours post-dose on Day 1 of Cycle 2 |
| Pharmacokinetics: Area Under the Concentration Curve Versus Time From Time 0 to Last Quantifiable Value (AUC0-tlast) of Capecitabine | AUC0-tlast for Capecitabine, 5'-deoxy-5-fluorouridine (5'-DFUR) and 5-fluorouracil (5-FU) was calculated from the plasma concentration-time data for each analyte for Cycle 2, Day 1. | Pre-dose to 6 hours post-dose on Day 1 of Cycle 2 |
| Pharmacokinetics: Maximum Observed Concentration (Cmax) of Capecitabine | Cmax for Capecitabine, 5'-deoxy-5-fluorouridine (5'-DFUR) and its metabolites 5-fluorouracil (5-FU) was calculated from the plasma concentration-time data for each analyte for Day 1 of Cycle 2. | From pre-dose to 6 hours post-dose on Day 1 of Cycle 2 |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate) | Response rate was defined as percent of participants with objective response [CR or PR] over randomized and treated participants using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) Guidelines. CR was defined as the disappearance of all tumor 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 of LDs or complete disappearance of target lesions, with persistence (but not worsening) of one or more non-target lesions. No new lesions may have appeared. | Randomization to last visit (up to 9.66 months) |
| Duration of Response (DOR) | The DOR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. According to the Response Evaluation Criteria in Solid Tumors (RECIST V1.0) criteria, CR was the disappearance of all tumor lesions. PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions, with occurrence of no new lesions. For participants not known to have died as of the data cut-off date and who did not have progressive disease, DOR was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, DOR was censored at the date of last visit with adequate assessment. | Randomization to last visit (up to 9.66 months) |
| Overall Survival (OS) | OS was defined as the time in months from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last contact date. | Randomization to date of death from any cause up to 20.83 months |
| Pharmacology Toxicity and Adverse Events (AEs) | Data presented are the number of participants who experienced serious AEs, AEs, death due to progressive disease (PD), death due to AEs while on treatment and death during the 30-day post-treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | Baseline to study completion [Cycle 19 (21 days/cycle) and 30-day safety follow-up] |
| Argentina |
| 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. | Resistencia | 3500 | Argentina |
| 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. | Tucumain | 4000 | Argentina |
| 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. | Garran | Australian Capital Territory | 2605 | Australia |
| 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. | Caringbah | New South Wales | 2229 | Australia |
| 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. | Wollongong | New South Wales | 2500 | Australia |
| 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. | Frankston | Victoria | 3199 | Australia |
| 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. | Nedlands | Western Australia | 6009 | Australia |
| 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. | Subiaco | Western Australia | 6008 | Australia |
| 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. | Avignon | 84082 | France |
| 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. | La Roche-sur-Yon | 85925 | France |
| 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. | Lyon | 69373 | France |
| 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. | Paris | 75651 | France |
| 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. | Saint-Brieuc | 22015 | France |
| 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. | Acapulco | 39670 | Mexico |
| 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. | Chihuahua City | 31238 | Mexico |
| 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. | Cuernavaca | 62290 | Mexico |
| 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. | Guadalajara | 44670 | Mexico |
| 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. | Mexico City | 07300 | Mexico |
| 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. | Durban | 4091 | South Africa |
| FG001 |
| Capecitabine + Placebo |
Capecitabine: 1250 mg/m^2, BID on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease. Placebo: taken as 4 tablets orally, daily, to complete 21-day cycles until progressive disease. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to treat (ITT) Population: All randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Capecitabine + Enzastaurin | Capecitabine: 1250 milligrams per square meter (mg/m^2), twice daily (BID) on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease. Enzastaurin: 1125-milligram (mg) loading dose on Day 1 of Cycle 1, then 500 mg daily on subsequent days to complete 21-day cycles until progressive disease. |
| BG001 | Capecitabine + Placebo | Capecitabine: 1250 mg/m^2, BID on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycles until progressive disease. Placebo: taken as 4 tablets orally, tablets daily, to complete 21-day cycles until progressive disease. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Body Mass Index (BMI) | The BMI was reported for 41 participants from each treatment arm. BMI is a measure of body fat based on height and weight that applies to adult men and women. | Mean | Standard Deviation | kilograms per square meter (kg/m^2) |
| ||||||||||||||
| Body Surface Area (BSA) | The BSA was reported for 41 participants from each treatment arm. Calculated to express in square meter (m^2). | Mean | Standard Deviation | square meter (m^2) |
| ||||||||||||||
| Disease Stage | Stage (St) I-small tumor without spread to the axillary lymph nodes (ALN). St II-small to large with or without spreading to nearby ALN, St IIA-no tumor in breast but found in 1-3 ALN; tumor in breast <2.0cm plus spread to ALN; tumor is >2 to 5cm and no spread to ALN. St IIB-tumor >2 to 5cm with spread to 1-3 ALN; tumor is >5 cm with no LN spread. St IIIA- tumor any size with spread to 4-9 ALN or internally mammary LN; the tumor is > 5cm; spread to 1 to 3 ALN. St IIIB-spread to chest and/or skin. St IIIC-spread to 10 or more ALN. St IV and IVB- cancer has spread to other organs of the body. | Count of Participants | Participants | No |
|
| 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 | Progression Free Survival (PFS) | PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy. | Intent-to-treat (ITT) population: All randomized participants who received at least 1 dose of study drug. Participants censored: Capecitabine + Enzastaurin = 13; Capecitabine + Placebo = 14. | Posted | Median | 95% Confidence Interval | months | Randomization to measured progressive disease or death up to 14 months |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Expression of Tumor Markers in Tissue Samples (Tumor Markers and Genes Evaluation) | Protein expression was planned to be measured using an Immunohistochemistry (IHC) assay to determine membrane and cytoplasmic phosphorylated glycogen synthase kinase 3 beta (pGSK3B), nuclear phosphorylated adenosine 3'5'-cyclic monophosphate (cAMP) response-element binding protein (pCREB), cytoplasmic pCREB, protein kinase C beta 2 (PKCB2), cytoplasmic phospho S6 (pS6), and cytoplasmic phosphatase and tensin homolog (PTEN) IHC H-scores. Tumor tissue samples were to be scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining, and H- scores calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+) . | Zero participants were analyzed. The study was terminated and no data was collected. | Posted | Randomization, Cycle 2, end of study |
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| Secondary | Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State | Area Under the Concentration versus time curve during 1 dosing interval at steady state (AUCτ,ss) for Cycle 2 Day 1 for Enzastaurin, its metabolite LY326020 and total analytes (enzastaurin + LY326020). AUCτ,ss was calculated using concentration versus time data by post hoc estimation of enzastaurin, its metabolite LY326020, and total analytes (enzastaurin + LY326020). | All randomized participants who received at least 1 dose of enzastaurin and had data for AUCτ,ss analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomoles*hour per liter (nmol*hr/L) | From pre-dose to 24 hours post-dose on Day 1 of Cycle 2 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: Area Under the Concentration Curve Versus Time From Time 0 to Last Quantifiable Value (AUC0-tlast) of Capecitabine | AUC0-tlast for Capecitabine, 5'-deoxy-5-fluorouridine (5'-DFUR) and 5-fluorouracil (5-FU) was calculated from the plasma concentration-time data for each analyte for Cycle 2, Day 1. | All randomized participants who received at least 1 dose of capecitabine and had data for AUC 0-tlast analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*hour/milliliter (ug*hr/mL) | Pre-dose to 6 hours post-dose on Day 1 of Cycle 2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: Maximum Observed Concentration (Cmax) of Capecitabine | Cmax for Capecitabine, 5'-deoxy-5-fluorouridine (5'-DFUR) and its metabolites 5-fluorouracil (5-FU) was calculated from the plasma concentration-time data for each analyte for Day 1 of Cycle 2. | All randomized participants who received at least 1 dose of capecitabine and had data for Cmax analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter(ug/mL) | From pre-dose to 6 hours post-dose on Day 1 of Cycle 2 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate) | Response rate was defined as percent of participants with objective response [CR or PR] over randomized and treated participants using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) Guidelines. CR was defined as the disappearance of all tumor 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 of LDs or complete disappearance of target lesions, with persistence (but not worsening) of one or more non-target lesions. No new lesions may have appeared. | Intent-to-treat (ITT) population: All randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to last visit (up to 9.66 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | The DOR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. According to the Response Evaluation Criteria in Solid Tumors (RECIST V1.0) criteria, CR was the disappearance of all tumor lesions. PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions, with occurrence of no new lesions. For participants not known to have died as of the data cut-off date and who did not have progressive disease, DOR was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, DOR was censored at the date of last visit with adequate assessment. | Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study drug with a CR or PR. Participants censored: Capecitabine + Enzastaurin = 3; Capecitabine + Placebo = 2. | Posted | Median | 95% Confidence Interval | months | Randomization to last visit (up to 9.66 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time in months from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last contact date. | Intent-to-treat (ITT) population: All randomized participants who received at least 1 dose of study drug. Participants censored: Capecitabine + Enzastaurin = 23; Capecitabine + Placebo = 28. | Posted | Median | 95% Confidence Interval | months | Randomization to date of death from any cause up to 20.83 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacology Toxicity and Adverse Events (AEs) | Data presented are the number of participants who experienced serious AEs, AEs, death due to progressive disease (PD), death due to AEs while on treatment and death during the 30-day post-treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | Posted | Count of Participants | Participants | No | Baseline to study completion [Cycle 19 (21 days/cycle) and 30-day safety follow-up] |
|
|
Baseline to study completion [Cycle 19 (21 days/cycle) and 30-day safety follow-up]
Study-specific clinical outcomes due to progressive disease (PD) were not considered to be serious adverse events (SAEs) unless it was deemed related to study drug by the investigator.
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 | A - Capecitabine + Enzastaurin | Capecitabine: 1250 milligrams per square meter (mg/m^2) twice daily (BID) on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease. Enzastaurin: 1125-milligram (mg) loading dose on Day 1 of Cycle 1, then 500 mg daily on subsequent days to complete 21-day cycles until progressive disease. | 12 | 42 | 38 | 42 | ||
| EG001 | B - Capecitabine + Placebo | Capecitabine: 1250 mg/m^2 BID on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease. Placebo: 4 tablets orally, daily, to complete 21-day cycles until progressive disease. | 12 | 43 | 40 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 12.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 12.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 12.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 12.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 12.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 12.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 12.0 | Systematic Assessment |
| |
| Sudden death | General disorders | 12.0 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | 12.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 12.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 12.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 12.0 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | 12.0 | Systematic Assessment |
| |
| Biopsy | Investigations | 12.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 12.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 12.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 12.0 | Systematic Assessment |
| |
| Coma | Nervous system disorders | 12.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | 12.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | 12.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 12.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | 12.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 12.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 12.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 12.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 12.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 12.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 12.0 | Systematic Assessment |
| |
| Pain | General disorders | 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 12.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | 12.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | 12.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 12.0 | Systematic Assessment |
| |
| Urine colour abnormal | Investigations | 12.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 12.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | 12.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 12.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | 12.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 12.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 12.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 12.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | 12.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 12.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 12.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | 12.0 | Systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | 12.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C504878 | enzastaurin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Hispanic |
|
| Mexico |
|
| Argentina |
|
| Australia |
|
| Canada |
|
| Stage II |
|
| Stage IIA |
|
| Stage IIB |
|
| Stage III |
|
| Stage IIIA |
|
| Stage IIIB |
|
| Stage IIIC |
|
| Stage IV |
|
| Stage IVB |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
|
|
| OG001 | Capecitabine + Placebo | Capecitabine: 1250 mg/m^2 BID on Days 1-14 followed by a 1-week rest period (Days 15-21) for each 21-day cycle until progressive disease. Placebo: 4 tablets orally, daily, to complete 21-day cycles until progressive disease. |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|