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| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-S038 | Other Identifier | Eli Lilly and Company |
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Study has been terminated due to slow enrollment
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed with locally recurrent or metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzastaurin + Bevacizumab + Paclitaxel | Experimental | Participants randomized to this arm (Arm A) will receive enzastaurin, paclitaxel and bevacizumab until disease progression. Prior to randomization, a safety lead-in will be conducted in 6 participants who will be treated according to Arm A for 2 cycles (1 cycle = 28 days). Only after an acceptable safety analysis of the safety lead-in, will other participants be randomized to Phase 2 (either Arm A or Arm B). In Phase 2, participants from the safety lead-in will continue treatment according to Enzastaurin + Bevacizumab + Paclitaxel (Arm A). |
|
| Bevacizumab + Paclitaxel + Placebo | Placebo Comparator | Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzastaurin | Drug | 1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time from the date of study enrollment to the first date of objectively determined progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). PD is ≥20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died and who did not have PD, PFS was censored at the date of the last progression-free assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation systemic anticancer therapy. No participant completed a full cycle of therapy and thus no formal analysis was performed. | Baseline to measured PD (up to 15 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR), assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). CR was defined as the disappearance of all tumor lesions; PR was defined as either ≥30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions. In either case of PR, no new lesions should have appeared. The percentage of participants with ORR was calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100. No participant completed a full cycle of therapy and thus no formal analysis was performed. |
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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. | Newark | Delaware | 19713 |
This study consisted of a safety lead-in prior to randomization. The study was terminated prior to completion of safety lead-in period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enzastaurin + Bevacizumab + Paclitaxel | Safety Lead-in Period: Enzastaurin 1125 milligrams (mg) loading dose (total nine 125-mg tablets: 3 tablets, 3 times daily) administered orally, only on Day 1 of Cycle 1, followed by 500 mg (four 125-mg tablets) administered orally, once daily in a 28-day cycle plus bevacizumab 10 milligrams per kilogram (mg/kg) administered intravenously on Days 1 and 15 of every 28-day cycle plus paclitaxel 90 milligrams per square meter (mg/m^2) administered intravenously on Days 1, 8 and 15 of every 28-day cycle. Participants were to receive enzastaurin, bevacizumab and paclitaxel for 2 cycles (1 cycle = 28 days). Randomization Period: Participants were to receive the same treatment as administered during the safety lead-in period. Treatment was to continue until there was evidence of disease progression or intolerable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bevacizumab | Drug | 10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression |
|
| Paclitaxel | Drug | 90 milligrams per square meter (mg/m^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression |
|
| Placebo | Drug | Oral, daily, until disease progression |
|
| Baseline to measured Progressive disease (up to 15 days) |
| Number of Participants With Adverse Events (AEs) or Any Serious AEs (SAEs) | A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. | Baseline to study completion (Day 15) plus 30-day safety follow-up |
| United States |
| 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. | Galesburg | Illinois | 61401 | United States |
| 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. | Fort Wayne | Indiana | 46815 | United States |
| 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. | Goshen | Indiana | 46526 | United States |
| 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. | Indianapolis | Indiana | 46202 | United States |
| 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. | Lafayette | Indiana | 47905 | United States |
| 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. | Omaha | Nebraska | 68114 | United States |
| FG001 | Bevacizumab + Paclitaxel + Placebo | Safety lead-in Period: No treatment Randomization Period: Participants were to receive bevacizumab 10 mg/kg administered intravenously on Days 1 and 15 of every 28-day cycle plus paclitaxel 90 mg/m^2 administered intravenously on Days 1, 8 and 15 of every 28-day cycle plus placebo loading dose administered orally (total 9 tablets: 3 tablets, 3 times daily) only on Day 1 of Cycle 1, followed by oral administration once daily in a 28-day cycle. Treatment was to continue until there was disease progression or intolerable toxicity. |
| Entered Safety lead-in |
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| Randomized |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enzastaurin + Bevacizumab + Paclitaxel | Safety Lead-in Period: Enzastaurin 1125 milligrams (mg) loading dose (total nine 125-mg tablets: 3 tablets, 3 times daily) administered orally, only on Day 1 of Cycle 1, followed by 500 mg (four 125-mg tablets) administered orally, once daily in a 28-day cycle plus bevacizumab 10 milligrams per kilogram (mg/kg) administered intravenously on Days 1 and 15 of every 28-day cycle plus paclitaxel 90 milligrams per square meter (mg/m^2) administered intravenously on Days 1, 8 and 15 of every 28-day cycle. Participants were to receive enzastaurin, bevacizumab and paclitaxel for 2 cycles (1 cycle = 28 days). Randomization Period: Participants were to receive the same treatment as administered during the safety lead-in period. Treatment was to continue until there was evidence of disease progression or intolerable toxicity. |
| 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 |
|
| 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 the date of study enrollment to the first date of objectively determined progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). PD is ≥20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died and who did not have PD, PFS was censored at the date of the last progression-free assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation systemic anticancer therapy. No participant completed a full cycle of therapy and thus no formal analysis was performed. | No participant completed a full cycle of therapy and data were not collected for this Outcome Measure. | Posted | Baseline to measured PD (up to 15 days) |
|
| |||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR), assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). CR was defined as the disappearance of all tumor lesions; PR was defined as either ≥30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions. In either case of PR, no new lesions should have appeared. The percentage of participants with ORR was calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100. No participant completed a full cycle of therapy and thus no formal analysis was performed. | No participant completed a full cycle of therapy and data were not collected for this Outcome Measure. | Posted | Baseline to measured Progressive disease (up to 15 days) |
| ||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) or Any Serious AEs (SAEs) | A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. | All enrolled participants. | Posted | Count of Participants | Participants | No | Baseline to study completion (Day 15) plus 30-day safety follow-up |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enzastaurin + Bevacizumab + Paclitaxel | Safety Lead-in Period: Enzastaurin 1125 milligrams (mg) loading dose (total nine 125-mg tablets: 3 tablets, 3 times daily) administered orally, only on Day 1 of Cycle 1, followed by 500 mg (four 125-mg tablets) administered orally, once daily in a 28-day cycle plus bevacizumab 10 milligrams per kilogram (mg/kg) administered intravenously on Days 1 and 15 of every 28-day cycle plus paclitaxel 90 milligrams per square meter (mg/m^2) administered intravenously on Days 1, 8 and 15 of every 28-day cycle. Participants were to receive enzastaurin, bevacizumab and paclitaxel for 2 cycles (1 cycle = 28 days). Randomization Period: Participants were to receive the same treatment as administered during the safety lead-in period. Treatment was to continue until there was evidence of disease progression or intolerable toxicity. | 0 | 2 | 2 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
The study was terminated early due to slow enrollment and competing studies.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| 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 |
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| ID | Term |
|---|---|
| C504878 | enzastaurin |
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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| Unknown or Not Reported |
|
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