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| ID | Type | Description | Link |
|---|---|---|---|
| I3G-JE-JGCC | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese patients with advanced and/or metastatic solid tumors for which no proven effective therapy exists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2584702 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2584702 | Drug | Dose escalation starting at 50 milligram (mg). On Day 1, subjects will receive a single oral dose. After a two-day observation period, subjects will receive oral doses twice daily for a 28-day cycle. Patients may continue 28-day cycles of twice daily dosing until discontinuation criteria are met. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Effects | A clinically significant effect was any event that was a dose-limiting toxicity event (DLT). DLT was defined as an adverse event related to LY2584702 during Cycle 1 (Day 1 to Day 30) that fulfills any one of the following criteria; Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 non-hematological toxicity; platelet count <50.0 x 10^9/Liter (L) with bleeding; CTCAE Grade 4 platelet count decreased; neutrophil count <0.5 x 10^9/L lasting for 5 days or longer; any febrile neutropenia; CTCAE Grade 4 anemia; participant risk due to increasing toxicity. | Baseline through 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Tumor Response | Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is ≥30% decrease in sum of longest diameter of target lesions. | Baseline to study completion up to Day 183 |
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Inclusion Criteria:
Have histological or cytological evidence of a diagnosis of advanced and/or metastatic cancer (solid tumors) that is refractory to standard therapy and/or therapies known to provide clinical benefit, or for which no standard therapy exists.
Have the presence of disease amenable to efficacy assessment as defined by the Response Evaluation Criteria In Solid Tumors (RECIST). Japanese patients who have advanced non-measurable disease with elevation of a validated tumor marker may be eligible, if discussed and agreed upon by the investigator and Lilly.
Have adequate organ function including:
Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group scale
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy prior to study enrollment and recovered from the acute effects of therapy.
Have an estimated life expectancy of 12 weeks or greater
Are 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 |
|---|---|---|---|---|---|---|
| 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. | Chiba | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | 50 mg LY2584702 | 50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle |
| FG001 | 75 mg LY2584702 | 75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 50 mg LY2584702 | 50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle |
| BG001 | 75 mg LY2584702 |
| 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 Clinically Significant Effects | A clinically significant effect was any event that was a dose-limiting toxicity event (DLT). DLT was defined as an adverse event related to LY2584702 during Cycle 1 (Day 1 to Day 30) that fulfills any one of the following criteria; Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 non-hematological toxicity; platelet count <50.0 x 10^9/Liter (L) with bleeding; CTCAE Grade 4 platelet count decreased; neutrophil count <0.5 x 10^9/L lasting for 5 days or longer; any febrile neutropenia; CTCAE Grade 4 anemia; participant risk due to increasing toxicity. | All participants who were enrolled in the study. | Posted | Count of Participants | Participants | No | Baseline through 30 days |
|
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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 | 50 mg LY2584702 | 50 milligram (mg) LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | 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 |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C588151 | LY2584702 |
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|
| Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2584702 | AUC of single dose is AUC(0-12hours), and AUC of multiple doses is AUC during one dosing interval at steady state. | Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2584702 | Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose |
75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Pathological Diagnosis | Count of Participants | Participants | No |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status Prior to Cycle 1 | Classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Count of Participants | Participants | No |
|
| OG001 | 75 mg LY2584702 | 75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle |
|
|
| Secondary | Number of Participants With Tumor Response | Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is ≥30% decrease in sum of longest diameter of target lesions. | All participants who were enrolled in the study. | Posted | Count of Participants | Participants | No | Baseline to study completion up to Day 183 |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2584702 | AUC of single dose is AUC(0-12hours), and AUC of multiple doses is AUC during one dosing interval at steady state. | All participants who were enrolled in the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*hr/mL) | Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose |
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY2584702 | All participants who were enrolled in the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose |
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|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | 75 mg LY2584702 | 75 mg LY2584702 single oral dose on Day 1. After a two-day observation period, participants received oral doses twice daily for a 28-day cycle | 0 | 6 | 6 | 6 |
| Cheilitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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