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| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-S019 | Other Identifier | Eli Lilly and Company |
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Participants with ovarian cancer usually get the drugs carboplatin and paclitaxel as initial treatment. In many participants the tumor will shrink, or even disappear, after treatment with these drugs. But, unfortunately, the tumor will grow again in many participants. This trial will try to address the question: Can we delay the time till the tumor grows again by adding a 3rd drug to the standard therapy? To answer this question, participants will, by chance, either get the experimental drug enzastaurin or a "dummy pill" (placebo) during the chemotherapy and for up to 3 years after chemotherapy. Participants and physicians will not know if a participant gets enzastaurin or placebo (double-blinded trial). After a predefined time, the treatment will be uncovered, and the number of participants with tumor growth at a specific time point will be compared between the two treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (Part A) | Experimental | Enzastaurin: 1125 milligram (mg) loading dose then 500 mg oral tablet, daily for six 21-day cycles or up to 3 years Carboplatin: Area under the concentration time curve (AUC) 5 intravenous (IV), every (q) 21 days for six 21-day cycles Paclitaxel:175 milligrams/square meter (mg/m²) IV, q21 days for six 21-day cycles |
|
| B (Part B) | Placebo Comparator | Carboplatin: AUC5 IV, q21 days for six 21-day cycles Paclitaxel: 175 mg/m², IV, q21 days for six 21-day cycles Placebo: oral tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin | Drug |
|
| |
| carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Progression-Free Survival (PFS) | PFS was defined as time from date of randomization to first date of determined progressive disease (PD) or death from any cause. PD defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) and Gynecological Cancer Intergroup (GCIG) criteria. RECIST: ≥20% increase in sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since treatment started or appearance of ≥ 1new lesions and/or unequivocal progression of existing non-target lesions. GCIG: Cancer Antigen-125 (CA-125) serum ≥2 times upper limit of normal (ULN) for those in normal range or nadir for participants who never achieved normal range. Participants not known to have died and did not have PD were censored at last progression-free assessment. Those who received subsequent systemic anticancer therapy (after study drug discontinued) prior to determined PD or death, were censored at date of last progression-free disease assessment prior to post-discontinuation chemotherapy. | Randomization up to date of PD or death (up to 28.6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Percentage of Participants With PFS at 2 Years | PFS was defined as time from date of randomization to first date of determined PD or death from any cause. PD defined using RECIST v1.0 and GCIG criteria. RECIST v1.0: as ≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. GCIG: CA-125 serum ≥2 times ULN for those in normal range or nadir (the lowest value of blood counts after chemotherapy) for participants who never achieved normal range. Participants not known to have died and did not have PD were censored at last progression-free assessment. Those who received subsequent systemic anticancer therapy (after study drug discontinued) prior to determined PD or death, were censored at date of last progression-free disease assessment prior to post-discontinuation chemotherapy. |
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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. | Leuven | 3000 |
Part 1: Unblinded, single cohort safety lead-in of enzastaurin (enz) with paclitaxel (pac)/carboplatin (carb). Part 2: Randomized, double-blind, placebo-controlled trial consisting of: Baseline, Chemotherapy (start of study drug to discontinuation of pac and carb), Maintenance (day chemotherapy ends to study completion), Follow-up (up to 3 years).
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 - Modified Regimen A | Enzastaurin: 1125 milligrams (mg) loading dose on Cycle 1 Day 4 then 500 mg oral tablet, daily (QD), for six 21-day cycles on subsequent days of chemotherapy Carboplatin: Area under the concentration time curve (AUC)5 intravenous (IV), every (q) 21 days, for six 21-day cycles of chemotherapy Paclitaxel: 175 milligrams/square meter (mg/m²), IV, q21 days, for six 21-day cycles of chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| paclitaxel | Drug |
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| placebo | Drug |
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| Randomization to measured PD evaluated at 2 years |
| Part 2: Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | ORR was the percentage of participants with a CR or PR using RECIST v1.0 and CA-125 GCIG criteria. RECIST v1.0: CR was defined as the disappearance of all tumors. PR was defined ≥30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD or complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions and appearance of no new lesions. GCIG: CA-125 serum ≥2 times above ULN for those in normal range or nadir for participants who never achieved normal range. ORR calculated as: (CR + PR) / (total number of participants qualified for tumor response analysis per arm) * 100. | Randomization to PD or death from any cause (up to 28.6 months) |
| Part 2: Percentage of Participants With CR or PR or Stable Disease (SD) (Rate of Response) | Rate of response was defined using RECIST v1.0 and CA-125 GCIG criteria. RECIST v1.0: CR was defined as the disappearance of all target lesions. PR was defined ≥30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD or complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions and appearance of no new lesions. SD was defined as small changes that did not meet the above criteria. PD was defined as having a ≥20% increase in the sum of the LD of target lesions. GCIG: CA-125 serum ≥2 times above ULN for those in normal range or nadir for participants who never achieved normal range. Rate of response calculated as: (CR + PR + SD)/(total number of participants qualified for tumor response analysis per arm) *100. | Randomization to PD or death from any cause (up to 28.6 months) |
| Part 2: Translational Research: PFS Based on Protein Expression (PE) (To Assess Biological Markers in Tumors That Could Indicate Who Could Benefit From Enzastaurin Treatment) | PE measured using Immunohistochemistry (IHC) assay, scored 0 (negative, no staining) to 3+ (brightest staining). IHC H-scores for protein biomarkers (PKCβ2, PTEN, pCREB, pGSK3b, pS6) calculated as: [1*(percentage of cells stained [PCS] as 1+)]+[2*(PCS as 2+)]+[3*(PCS as 3+)]. High PE: ≥marker threshold value and Low PE: \ | Randomization up to date of PD or death (up to 28.6 months) |
| Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs) and the Number of Participants Who Died (To Compare the Safety of the 2 Treatments) | Clinically significant events were defined as SAEs and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. The number of participants SAEs, other non-serious AEs, and those who died due to PD are included. | Randomization up to 28.6 months |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) for Carboplatin With and Without Enzastaurin for Part 1 of Study | Cycle 1 Day 1 (carb) and Cycle 2 Day 1 (carb + enz); carb 0.25 hours (h) (prior to infusion), 0.5, 1, 2, 3, 5, and 21h after start of infusion |
| PK: Cmax for Paclitaxel With and Without Enzastaurin for Part 1 of Study | Cycle 1 Day 1 (pac) and Cycle 2 Day 1 (pac + enz); pac 1, 2, 3h (immediately after stopping infusion), 3.25, 3.5, 4, 5, 6, 8, 24, and 30h after start of infusion |
| PK: AUC From Time 0 to Infinity (AUC0-∞) for Carboplatin With and Without Enzastaurin for Part 1 of Study | Cycle 1 Day 1 (carb) and Cycle 2 Day 1 (carb + enz); carb at 0.25h (prior to infusion), 0.5, 1, 2, 3, 5, and 21h after start of infusion |
| PK: AUC0-∞ for Paclitaxel With and Without Enzastaurin for Part 1 of Study | Cycle 1 Day 1 (pac) and Cycle 2 Day 1 (pac + enz); pac at 1, 2, 3h (immediately after stopping infusion), 3.25, 3.5, 4, 5, 6, 8, 24, and 30h after start of infusion |
| PK: Cmax at Steady State (Cmax,ss) for Part 1 of Study | Cmax,ss for enzastaurin, its metabolite LSN326020 (LY326020) and total analytes are reported. | Cycle 1 Day 21 (enz) and Cycle 2 Day 1 (carb + pac + enz) at pre-dose, 2, 4, 6, 8 and 24h after the enz dose |
| PK: AUC During the Dosing Interval at Steady State (AUCτ,ss) for Part 2 of Study | AUCτ,ss for enzastaurin, its metabolite LSN326020 (LY326020), and total analytes are reported. | Cycle 2 Day 1 (carb + pac + enz) at pre-dose, 2, 4, 6, 8 and 24h after the enz dose |
| Belgium |
| 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. | Liège | 4000 | Belgium |
| 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. | Berlin | 13353 | Germany |
| 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. | Düsseldorf | 40489 | Germany |
| 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. | Erlangen | D-91054 | Germany |
| 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. | Wiesbaden | D-65199 | Germany |
| 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. | Gdansk | 80-402 | Poland |
| 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. | Warsaw | 02-781 | Poland |
| 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. | Ivanovo | 153040 | Russia |
| 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. | Kazan' | 420029 | Russia |
| 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. | Moscow | 115478 | Russia |
| 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. | Stavropol | 355047 | Russia |
| 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. | Barcelona | 08035 | Spain |
| 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. | Madrid | 28041 | Spain |
| 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. | Valencia | 46010 | Spain |
| FG001 | Part 2 - Regimen A | Enzastaurin: 1125 mg loading dose then 500 mg oral tablet on subsequent days, QD, for six 21-day cycles of chemotherapy and maintenance therapy up to 2 years Carboplatin: AUC5, IV, q21 days, for six 21-day cycles of chemotherapy Paclitaxel: 175 mg/m², IV, q21 days, for six 21-day cycles of chemotherapy |
| FG002 | Part 2 - Regimen B | Carboplatin: AUC5, IV, q21 days for six 21-day cycles of chemotherapy Paclitaxel: 175 mg/m², IV, q21 days for six 21-day cycles of chemotherapy Placebo: oral tablet, QD of chemotherapy and maintenance therapy up to 2 years |
| Received ≥1 Dose of Assigned Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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Part 1: All enrolled participants Part 2: All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 - Modified Regimen A | Enzastaurin: 1125 mg loading dose on Cycle 1 Day 4 then 500 mg oral tablet, QD, for six 21-day cycles on subsequent days of chemotherapy Carboplatin: AUC5, IV, q21 days, for six 21-day cycles of chemotherapy Paclitaxel: 175 mg/m², IV, q21 days, for six 21-day cycles of chemotherapy |
| BG001 | Part 2 - Regimen A | Enzastaurin: 1125 mg loading dose then 500 mg oral tablet, QD, for up to six 21-day cycles on subsequent days of chemotherapy and maintenance therapy up to 2 years Carboplatin: AUC5, IV, q21 days, for up to six 21-day cycles of chemotherapy Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy |
| BG002 | Part 2 - Regimen B | Carboplatin: AUC5 IV, q21 days, for up to six 21-day cycles of chemotherapy Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy Placebo: oral tablet, QD, of chemotherapy and maintenance therapy up to 2 years |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| 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 | |||||||||||||||||||||||
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| Primary | Part 2: Progression-Free Survival (PFS) | PFS was defined as time from date of randomization to first date of determined progressive disease (PD) or death from any cause. PD defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) and Gynecological Cancer Intergroup (GCIG) criteria. RECIST: ≥20% increase in sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since treatment started or appearance of ≥ 1new lesions and/or unequivocal progression of existing non-target lesions. GCIG: Cancer Antigen-125 (CA-125) serum ≥2 times upper limit of normal (ULN) for those in normal range or nadir for participants who never achieved normal range. Participants not known to have died and did not have PD were censored at last progression-free assessment. Those who received subsequent systemic anticancer therapy (after study drug discontinued) prior to determined PD or death, were censored at date of last progression-free disease assessment prior to post-discontinuation chemotherapy. | All randomized participants from Part 2 group. Participants censored for Part 2: Regimen A=38, Regimen B=35. Per protocol, Part 1 was not included as it is an open-label safety lead-in portion with PK characterization. | Posted | Median | 95% Confidence Interval | months | Randomization up to date of PD or death (up to 28.6 months) |
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| Secondary | Part 2: Percentage of Participants With PFS at 2 Years | PFS was defined as time from date of randomization to first date of determined PD or death from any cause. PD defined using RECIST v1.0 and GCIG criteria. RECIST v1.0: as ≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. GCIG: CA-125 serum ≥2 times ULN for those in normal range or nadir (the lowest value of blood counts after chemotherapy) for participants who never achieved normal range. Participants not known to have died and did not have PD were censored at last progression-free assessment. Those who received subsequent systemic anticancer therapy (after study drug discontinued) prior to determined PD or death, were censored at date of last progression-free disease assessment prior to post-discontinuation chemotherapy. | All randomized participants from Part 2 group. Participants censored for Part 2: Regimen A=38, Regimen B=35. Per protocol, Part 1 was not included as it is an open-label safety lead-in portion with PK characterization. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to measured PD evaluated at 2 years |
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| Secondary | Part 2: Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | ORR was the percentage of participants with a CR or PR using RECIST v1.0 and CA-125 GCIG criteria. RECIST v1.0: CR was defined as the disappearance of all tumors. PR was defined ≥30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD or complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions and appearance of no new lesions. GCIG: CA-125 serum ≥2 times above ULN for those in normal range or nadir for participants who never achieved normal range. ORR calculated as: (CR + PR) / (total number of participants qualified for tumor response analysis per arm) * 100. | All randomized participants from Part 2 group, who were evaluated for tumor response. Per protocol, Part 1 was not included as it is an open-label safety lead-in portion with PK characterization. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to PD or death from any cause (up to 28.6 months) |
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| Secondary | Part 2: Percentage of Participants With CR or PR or Stable Disease (SD) (Rate of Response) | Rate of response was defined using RECIST v1.0 and CA-125 GCIG criteria. RECIST v1.0: CR was defined as the disappearance of all target lesions. PR was defined ≥30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD or complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions and appearance of no new lesions. SD was defined as small changes that did not meet the above criteria. PD was defined as having a ≥20% increase in the sum of the LD of target lesions. GCIG: CA-125 serum ≥2 times above ULN for those in normal range or nadir for participants who never achieved normal range. Rate of response calculated as: (CR + PR + SD)/(total number of participants qualified for tumor response analysis per arm) *100. | All randomized participants from Part 2 group, who qualified for tumor response analysis. Per protocol, Part 1 was not included as it is an open-label safety lead-in portion with PK characterization. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to PD or death from any cause (up to 28.6 months) |
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| Secondary | Part 2: Translational Research: PFS Based on Protein Expression (PE) (To Assess Biological Markers in Tumors That Could Indicate Who Could Benefit From Enzastaurin Treatment) | PE measured using Immunohistochemistry (IHC) assay, scored 0 (negative, no staining) to 3+ (brightest staining). IHC H-scores for protein biomarkers (PKCβ2, PTEN, pCREB, pGSK3b, pS6) calculated as: [1*(percentage of cells stained [PCS] as 1+)]+[2*(PCS as 2+)]+[3*(PCS as 3+)]. High PE: ≥marker threshold value and Low PE: \ | All randomized participants (Pts) from Part 2 group. Pts censored: Regimens A/B (A/B)-High (H), Low (L) Expression: PKCβ2 Cytoplasm (Cyto) (H4/5,L26/22), PTEN Cyto (H24/24, L6/3), PTEN Membrane (H9/8, L21/19), PTEN Nucleus (H13/6, L17/21), pCREB Nucleus (H14/10, L16/17), pGSK3b Cyto (H7/3, L22/23), pS6 Cyto (H21/18, L9/9). | Posted | Median | 95% Confidence Interval | months | Randomization up to date of PD or death (up to 28.6 months) |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs) and the Number of Participants Who Died (To Compare the Safety of the 2 Treatments) | Clinically significant events were defined as SAEs and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. The number of participants SAEs, other non-serious AEs, and those who died due to PD are included. | All enrolled (Part 1) and all randomized (Part 2) participants who received at least 1 dose of study drug according to the treatment to which the participants were assigned. | Posted | Count of Participants | Participants | No | Randomization up to 28.6 months |
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| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) for Carboplatin With and Without Enzastaurin for Part 1 of Study | All enrolled participants with measurable Cmax in Part 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter (µg/mL) | Cycle 1 Day 1 (carb) and Cycle 2 Day 1 (carb + enz); carb 0.25 hours (h) (prior to infusion), 0.5, 1, 2, 3, 5, and 21h after start of infusion |
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| Secondary | PK: Cmax for Paclitaxel With and Without Enzastaurin for Part 1 of Study | All enrolled participants with measurable Cmax for pac in Part 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Cycle 1 Day 1 (pac) and Cycle 2 Day 1 (pac + enz); pac 1, 2, 3h (immediately after stopping infusion), 3.25, 3.5, 4, 5, 6, 8, 24, and 30h after start of infusion |
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| Secondary | PK: AUC From Time 0 to Infinity (AUC0-∞) for Carboplatin With and Without Enzastaurin for Part 1 of Study | All enrolled participants with measurable AUC0-∞ in Part 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams*minute/milliliter (mg*min/mL | Cycle 1 Day 1 (carb) and Cycle 2 Day 1 (carb + enz); carb at 0.25h (prior to infusion), 0.5, 1, 2, 3, 5, and 21h after start of infusion |
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| Secondary | PK: AUC0-∞ for Paclitaxel With and Without Enzastaurin for Part 1 of Study | All enrolled participants with measurable AUC0-∞ in Part 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Cycle 1 Day 1 (pac) and Cycle 2 Day 1 (pac + enz); pac at 1, 2, 3h (immediately after stopping infusion), 3.25, 3.5, 4, 5, 6, 8, 24, and 30h after start of infusion |
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| Secondary | PK: Cmax at Steady State (Cmax,ss) for Part 1 of Study | Cmax,ss for enzastaurin, its metabolite LSN326020 (LY326020) and total analytes are reported. | All enrolled participants with measurable Cmax,ss in Part 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | Cycle 1 Day 21 (enz) and Cycle 2 Day 1 (carb + pac + enz) at pre-dose, 2, 4, 6, 8 and 24h after the enz dose |
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| Secondary | PK: AUC During the Dosing Interval at Steady State (AUCτ,ss) for Part 2 of Study | AUCτ,ss for enzastaurin, its metabolite LSN326020 (LY326020), and total analytes are reported. | All randomized participants with measurable AUCτ,ss in Part 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | Cycle 2 Day 1 (carb + pac + enz) at pre-dose, 2, 4, 6, 8 and 24h after the enz dose |
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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 | Part 1 - Modified Regimen A | Enzastaurin: 1125 mg loading dose on Cycle 1 Day 4, then 500 mg oral tablet, QD, for six 21-day cycles on subsequent days of chemotherapy Carboplatin: AUC5, IV, q21 days, for six 21-day cycles Paclitaxel: 175 mg/m² IV, q21 days, for six 21-day cycles | 7 | 11 | 11 | 11 | ||
| EG001 | Part 2 - Regimen A | Enzastaurin: 1125 mg loading dose then 500 mg, oral tablets on subsequent days, QD, for six 21-day cycles or up to 2 years Carboplatin: AUC5, IV, q 21 days, for six 21-day cycles Paclitaxel: 175 mg/m², IV, q21 days, for six 21-day cycles | 26 | 67 | 60 | 67 | ||
| EG002 | Part 2 - Regimen B | Carboplatin: AUC5, IV, q21 days, for six 21-day cycles Paclitaxel: 175 mg/m2² IV, q 21 days, six 21 day cycles Placebo: oral tablet, QD | 20 | 72 | 56 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 15.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 15.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | 15.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | 15.0 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | 15.0 | Systematic Assessment |
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| Keratosis follicular | Congenital, familial and genetic disorders | 15.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | 15.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 15.0 | Systematic Assessment |
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| Diaphragmatic hernia | Gastrointestinal disorders | 15.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 15.0 | Systematic Assessment |
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| Faecaloma | Gastrointestinal disorders | 15.0 | Systematic Assessment |
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| Gastrointestinal obstruction | Gastrointestinal disorders | 15.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | 15.0 | Systematic Assessment |
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| Intestinal fistula | Gastrointestinal disorders | 15.0 | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | 15.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 15.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 15.0 | Systematic Assessment |
| |
| Hernia | General disorders | 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 15.0 | Systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | 15.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 15.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | 15.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 15.0 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | 15.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | 15.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | 15.0 | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | 15.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | 15.0 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | 15.0 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | 15.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 15.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 15.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 15.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 15.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 15.0 | Systematic Assessment |
| |
| Viith nerve paralysis | Nervous system disorders | 15.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | 15.0 | Systematic Assessment |
| |
| Ureteric perforation | Renal and urinary disorders | 15.0 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | 15.0 | Systematic Assessment |
| |
| Vaginal perforation | Reproductive system and breast disorders | 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 15.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 15.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 15.0 | Systematic Assessment |
| |
| Cardiac pacemaker insertion | Surgical and medical procedures | 15.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | 15.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 15.0 | Systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | 15.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | 15.0 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 15.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 15.0 | Systematic Assessment |
| |
| Photopsia | Eye disorders | 15.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 15.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 15.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 15.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 15.0 | Systematic Assessment |
| |
| Chills | General disorders | 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 15.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 15.0 | Systematic Assessment |
| |
| Oedema | General disorders | 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 15.0 | Systematic Assessment |
| |
| Pain | General disorders | 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 15.0 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 15.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 15.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 15.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 15.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | 15.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 15.0 | Systematic Assessment |
| |
| Urine colour abnormal | Investigations | 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 15.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 15.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 15.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | 15.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 15.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 15.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 15.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 15.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 15.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 15.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 15.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 15.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 15.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | 15.0 | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | 15.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 15.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 15.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 15.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 15.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 15.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 15.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | 15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 15.0 | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | 15.0 | Systematic Assessment |
| |
| Enterostomy | Surgical and medical procedures | 15.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | 15.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | 15.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | 15.0 | Systematic Assessment |
|
All of the percentages do not add up to 100% because of rounding.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C504878 | enzastaurin |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| East Asian |
|
| West Asian (Indian sub-continent) |
|
| Poland |
|
| Spain |
|
| Russia |
|
| Germany |
|
| OG001 | Part 2 - Regimen B | Carboplatin: AUC5, IV, q21 days, for up to six 21-day cycles of chemotherapy Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy Placebo: oral tablet, QD, of chemotherapy and maintenance therapy up to 2 years |
|
|
Carboplatin: AUC5 IV, q21 days, for up to six 21-day cycles of chemotherapy
Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy
Placebo: oral tablet, QD, of chemotherapy and maintenance therapy up to 2 years
|
|
| Part 2 - Regimen B |
Carboplatin: AUC5, IV, q21 days, for up to six 21-day cycles of chemotherapy Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy Placebo: oral tablet, QD, of chemotherapy and maintenance therapy up to 2 years |
|
|
| OG001 | Part 2 - Regimen B | Carboplatin: AUC5, IV, q21 days, for up to six 21-day cycles of chemotherapy Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy Placebo: oral tablet, QD, of chemotherapy and maintenance therapy up to 2 years |
|
|
| OG002 | Part 2 - Regimen B | Carboplatin: AUC5, IV, q21 days, for up to six 21-day cycles of chemotherapy Paclitaxel: 175 mg/m², IV, q21 days, for up to six 21-day cycles of chemotherapy Placebo: oral tablet, QD, of chemotherapy and maintenance therapy up to 2 years |
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