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| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-JE-JPBC | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate safety and side effects of LY2835219 in Japanese participants with advanced cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - 100 mg Abemaciclib | Experimental | 100 milligram (mg) abemaciclib administered orally every 12 hours (Q12H) in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
|
| Cohort 2 - 150 mg Abemaciclib | Experimental | 150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
|
| Cohort 3 - 200 mg Abemaciclib | Experimental | 200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2835219 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abemaciclib Dose-Limiting Toxicity (DLT) | DLT is defined as an adverse event between Day -3 and Day 29 of Cycle 1 that is possibly related to the study drug and fulfills any one of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. | Cycle 1 = 32 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Abemaciclib | Maximum plasma concentration on Day -3 and Day 28 of Cycle 1. | Cycle 1 Day -3: Predose, 1, 2, 4, 6, 8, 10, 24, 48 and 72 hours (hr) postdose; Cycle 1 Day 28: Predose, 1, 2, 4, 6, 8, 10 and 24 hr postdose (Cycle 1 = 32 days) |
| Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of Abemaciclib |
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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 from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. | Tokyo | 104-0045 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24919854 | Derived | Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13. |
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Participants completed the trial if they received at least one dose of study drug and met discontinuation criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - 100 mg Abemaciclib | 100 milligram (mg) abemaciclib administered orally every 12 hours (Q12H) in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
| FG001 | Cohort 2 - 150 mg Abemaciclib | 150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
| FG002 | Cohort 3 - 200 mg Abemaciclib | 200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - 100 mg Abemaciclib | 100 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
| BG001 | Cohort 2 - 150 mg Abemaciclib |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Abemaciclib Dose-Limiting Toxicity (DLT) | DLT is defined as an adverse event between Day -3 and Day 29 of Cycle 1 that is possibly related to the study drug and fulfills any one of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. | All participants who received at least one dose of study drug and took at least 75% of planned dose in Cycle 1 or experienced a DLT in Cycle 1. | Posted | Count of Participants | Participants | No | Cycle 1 = 32 days |
|
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All participants who received at least one dose of study drug.
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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 | Cohort 1 - 100 mg Abemaciclib | 100 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric fistula | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000590451 | abemaciclib |
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AUC on Day -3 and Day 28 of Cycle 1 are AUC from time zero to infinity [AUC(0-∞)] and AUC during one dosing interval at steady state (AUCτ,ss), respectively. |
| Cycle 1 Day -3: Predose, 1, 2, 4, 6, 8, 10, 24, 48 and 72 hr postdose; Cycle 1 Day 28: Predose, 1, 2, 4, 6, 8, 10 and 24 hr postdose (Cycle 1 = 32 days) |
| Percentage of Participants With a Tumor Response: Objective Response Rate (ORR) | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions. | Baseline to Measured Progressive Disease (Up To 24 months) |
| Japan |
150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
| BG002 | Cohort 3 - 200 mg Abemaciclib | 200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Cohort 2 - 150 mg Abemaciclib |
150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
| OG002 | Cohort 3 - 200 mg Abemaciclib | 200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Abemaciclib | Maximum plasma concentration on Day -3 and Day 28 of Cycle 1. | All participants who received at least one dose of study drug and had evaluable data for Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Cycle 1 Day -3: Predose, 1, 2, 4, 6, 8, 10, 24, 48 and 72 hours (hr) postdose; Cycle 1 Day 28: Predose, 1, 2, 4, 6, 8, 10 and 24 hr postdose (Cycle 1 = 32 days) |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of Abemaciclib | AUC on Day -3 and Day 28 of Cycle 1 are AUC from time zero to infinity [AUC(0-∞)] and AUC during one dosing interval at steady state (AUCτ,ss), respectively. | All participants who received at least one dose of study drug and had evaluable data for AUC. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour/Millilitre (ng*hr/mL) | Cycle 1 Day -3: Predose, 1, 2, 4, 6, 8, 10, 24, 48 and 72 hr postdose; Cycle 1 Day 28: Predose, 1, 2, 4, 6, 8, 10 and 24 hr postdose (Cycle 1 = 32 days) |
|
|
|
| Secondary | Percentage of Participants With a Tumor Response: Objective Response Rate (ORR) | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions. | All participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline to Measured Progressive Disease (Up To 24 months) |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Cohort 2 - 150 mg Abemaciclib | 150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. | 2 | 3 | 3 | 3 |
| EG002 | Cohort 3 - 200 mg Abemaciclib | 200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. | 2 | 6 | 6 | 6 |
| Biliary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 22.0 | Systematic Assessment |
|
| Anal inflammation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Electrocardiogram qt prolonged | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
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| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Cycle 1 Day 28 |
|
|
| AUCτ,ss (n=2,2,5) |
|
|