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| ID | Type | Description | Link |
|---|---|---|---|
| I4J-MC-HHBE | Other Identifier | Eli Lilly and Company | |
| 2012-003174-83 | EudraCT Number |
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Change in clinical strategy.
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The purpose of this study is to find a recommended dose of LY2940680 that can be safely given in combination with etoposide and carboplatin followed by LY2940680 alone in participants with extensive-disease small cell lung cancer. The study will also compare progression-free survival in participants who are administered etoposide, carboplatin and LY2940680 followed by LY2940680 alone versus etoposide, carboplatin, and placebo followed by placebo alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b: LY2940680 + C + E | Experimental | Phase 1b Dose Escalation: Cycles 1-6 (21 day cycles) LY2940680 administered orally, once daily at escalating doses (100 milligrams [mg] up to 400 mg) in combination with etoposide (E) 100 milligram per square meter (mg/m^2) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle and carboplatin (C) Area Under the Curve [AUC] 5 (mg•min/mL) administered by IV infusion on day 1 each cycle. Phase 1b Maintenance: Cycles 7+ (21 day cycles) LY2940680 administered orally, once daily at the same dose as induction. Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation. |
|
| Phase 2: Placebo + C + E | Placebo Comparator | Induction: Cycles 1-6 (21 day cycles) Placebo administered orally once daily in combination with etoposide 100 mg/m2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle. Maintenance: Cycles 7+ (21 day cycles) Placebo administered orally once daily. Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation. |
|
| Phase 2: LY2940680 + C+ E | Experimental | Induction: Cycles 1-6 (21 day cycles) LY2940680 (dose to be determined in Phase 1b portion) administered orally once daily in combination with etoposide 100 mg/m^2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle. Maintenance: Cycles 7+ (21 day cycles). LY2940680 (dose to be determined in Phase 1 portion) administered orally once daily. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2940680 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Recommended Phase 2 Dose of LY2940680: Maximum Tolerated Dose (MTD) | MTD was defined as the highest tested dose that has <33% probability of causing a dose-limiting toxicity(DLT). DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and fulfills any one of the following criterion using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE),version 4.0:Grade 3 non-hematological toxicity except nausea, vomiting, constipation, diarrhea, fatigue, or anorexia that is manageable with appropriate care,transient(i.e., ≤5 days) Grade 3 elevations of alanine aminotransferase(ALT) and/or aspartate aminotransferase(AST), without evidence of other hepatic injury, in the setting of preexisting hepatic metastasis, ≥Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia of any duration,CTCAE Grade 4 hematological toxicity of >5 days duration and any febrile neutropenia. any other significant toxicity deemed by the primary investigator and Lilly clinical research personnel to be dose-limiting. | Baseline to Completion of the Phase 1b (Up To 12 Months) |
| Phase 2: Progression-Free Survival | Randomization to Measured Progressive Disease or Death of Any Cause (Estimated as 18 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680, LSN3185556 at the Recommended Dose | Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours | |
| Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Carboplatin and Etoposide at the Recommended Dose |
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Inclusion Criteria:
Histological or cytological diagnosis of Small Cell Lung Cancer (SCLC), including malignant pleural effusion that is extensive stage per the International Staging System
Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) performance status schedule
No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC
Prior radiation therapy allowed to <25% of the bone marrow. Participants who have received prior radiation to the whole pelvis or chest for the treatment of SCLC are not eligible
At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Adequate organ function including the following:
Estimated life expectancy of at least 12 weeks
For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period
Availability of a tumor tissue sample
Able to swallow capsules
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 |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| Northeast Georgia Cancer Care, LLC |
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.
This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
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Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. Phase 1b study completer was defined as completion of the dose-limiting toxicity (DLT) period (1 cycle- 21 days cycle for LY2940680 in combination with carboplatin and etoposide.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b: 100 mg LY2940680 + C + E | 100 milligrams (mg) LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle. Area under the Curve (AUC) 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle. Maintenance: Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Carboplatin | Drug | Administered IV |
|
| Etoposide | Drug | Administered IV |
|
| Placebo | Drug | Administered orally |
|
| Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours |
| Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for LY2940680 and LSN3185556 at the Recommended Dose | Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours |
| Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for Etoposide and as AUC₀-₆ for Carboplatin at the Recommended Dose | Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours |
| Phase 1b: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) | ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. | Baseline to Study Completion Up to 39 Months |
| Phase 1b: Percentage Inhibition of Expression Levels of Gli1 in Skin Cells | The gene expression data (Gli1) was normalized and the level of percentage of Gli1 inhibition post treatment was calculated. | Baseline, Cycle 2 Day 1, Cycle 7 Day 1 |
| Phase 2: Overall Survival | Randomization to Study Completion (Estimated as 38 Months) |
| Phase 2: Percent Change in Tumor Size (CTS) | Randomization to End of Cycle 2 (Estimated as 24 Months) |
| Phase 2: Number of Participants With a Complete or Partial Tumor Response (Overall Response Rate) | Randomization to Study Completion (Estimated as 38 Months) |
| Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of LY2940680 andLSN3185556 at the Recommended Dose | Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours |
| Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of Carboplatin and Etoposide at the Recommended Dose | Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours |
| Athens |
| Georgia |
| 30607 |
| United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| New York Oncology Hematology Associate | Albany | New York | 12206 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Clinical Research Unit (ITOR) Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Accelerated Comm. Oncology Research Network (ACORN) | Memphis | Tennessee | 38119 | United States |
| The West Clinic | Memphis | Tennessee | 38120 | United States |
| US Oncology | The Woodlands | Texas | 77380 | United States |
| Tyler Cancer Center | Tyler | Texas | 75702 | United States |
| Northwest Cancer Specialists PC | Vancouver | Washington | 98684 | United States |
| Yakima Valley Memorial Hospital | Yakima | Washington | 98902 | 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. | London | SE1 9RT | United Kingdom |
| 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. | Manchester | M20 4BX | United Kingdom |
| FG001 | Phase 1b: 200 mg LY2940680 + C + E | 200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle. Area under the Curve (AUC) 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle. Maintenance: Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation. |
| FG002 | Phase 1B: 400 mg LY2940680 + C + E | 400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle. Area under the Curve (AUC) 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle. Maintenance: Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b: 100 mg LY2940680 + C +E | 100 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle. Area under the Curve [AUC] 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle. Maintenance: Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation. |
| BG001 | Phase 1b: 200 mg LY2940680 + C + E | 200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle. Area under the Curve [AUC] 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle. Maintenance: Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation. |
| BG002 | Phase 1b: 400 mg LY2940680 + C + E | 400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle. Area under the Curve [AUC] 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle. Maintenance: Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation. |
| BG003 | 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 (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Phase 1b: Recommended Phase 2 Dose of LY2940680: Maximum Tolerated Dose (MTD) | MTD was defined as the highest tested dose that has <33% probability of causing a dose-limiting toxicity(DLT). DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and fulfills any one of the following criterion using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE),version 4.0:Grade 3 non-hematological toxicity except nausea, vomiting, constipation, diarrhea, fatigue, or anorexia that is manageable with appropriate care,transient(i.e., ≤5 days) Grade 3 elevations of alanine aminotransferase(ALT) and/or aspartate aminotransferase(AST), without evidence of other hepatic injury, in the setting of preexisting hepatic metastasis, ≥Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia of any duration,CTCAE Grade 4 hematological toxicity of >5 days duration and any febrile neutropenia. any other significant toxicity deemed by the primary investigator and Lilly clinical research personnel to be dose-limiting. | All participants who received at least one dose of study drug and were enrolled in Phase1b of the study. | Posted | Number | milligrams (mg) | Baseline to Completion of the Phase 1b (Up To 12 Months) |
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| Primary | Phase 2: Progression-Free Survival | Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. | Posted | Randomization to Measured Progressive Disease or Death of Any Cause (Estimated as 18 Months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680, LSN3185556 at the Recommended Dose | All participants who received at least one dose of study drug and were enrolled in Phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (µg/mL) | Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours |
| ||||||||||||||||||||||||||||
| Secondary | Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Carboplatin and Etoposide at the Recommended Dose | All participants who received at least one dose of study drug and were enrolled in Phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. C and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (µg/mL) | Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours |
|
| |||||||||||||||||||||||||||
| Secondary | Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for LY2940680 and LSN3185556 at the Recommended Dose | All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*microgram per milliliter (h.µg/mL) | Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours |
| ||||||||||||||||||||||||||||
| Secondary | Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for Etoposide and as AUC₀-₆ for Carboplatin at the Recommended Dose | All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. C and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*microgram per milliliter (h.µg/mL) | Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours |
|
| |||||||||||||||||||||||||||
| Secondary | Phase 1b: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) | ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. | All participants who received at least one dose of drug. | Posted | Mean | 90% Confidence Interval | percentage of participants | Baseline to Study Completion Up to 39 Months |
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| Secondary | Phase 1b: Percentage Inhibition of Expression Levels of Gli1 in Skin Cells | The gene expression data (Gli1) was normalized and the level of percentage of Gli1 inhibition post treatment was calculated. | All participants who received at least one dose of drug and had samples available. | Posted | Median | Inter-Quartile Range | Percentage of Gli 1 Inhibition | Baseline, Cycle 2 Day 1, Cycle 7 Day 1 |
| |||||||||||||||||||||||||||
| Secondary | Phase 2: Overall Survival | Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. | Posted | Randomization to Study Completion (Estimated as 38 Months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Phase 2: Percent Change in Tumor Size (CTS) | Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. | Posted | Randomization to End of Cycle 2 (Estimated as 24 Months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Phase 2: Number of Participants With a Complete or Partial Tumor Response (Overall Response Rate) | Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. | Posted | Randomization to Study Completion (Estimated as 38 Months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of LY2940680 andLSN3185556 at the Recommended Dose | All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. | Posted | Median | Full Range | Hour (h) | Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours |
| ||||||||||||||||||||||||||||
| Secondary | Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of Carboplatin and Etoposide at the Recommended Dose | All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. C and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping. | Posted | Median | Full Range | Hour (h) | Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours |
|
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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 | Phase 1b: 100 mg LY2940680 + C + E | 100 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle. Area under the Curve [AUC] 5 (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle. | 3 | 6 | 6 | 6 | ||
| EG001 | Phase 1b: 200 mg LY2940680 + C + E | 200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle. Area under the Curve [AUC] 5 (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle. | 6 | 6 | 6 | 6 | ||
| EG002 | Phase 1b: 400 mg LY2940680 + C + E | 400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle. Area under the Curve [AUC] 5 (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle. | 8 | 14 | 14 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Post procedural inflammation | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Skin plaque | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C581399 | LY2940680 |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United Kingdom |
|
|
|
|
400 mg LY2940680 administered orally once daily (QD) for 6 cycles.
100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.
|
|
|
| OG002 | Phase 1b: 400 mg LY2940680 + C+ E | 400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle. Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle. |
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|