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| ID | Type | Description | Link |
|---|---|---|---|
| H9H-JE-JBAO | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and side effects of LY2157299 in combination with gemcitabine in Japanese participants with pancreatic cancer that is advanced or has spread to another part of the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2157299 + Gemcitabine | Experimental | 150 mg LY2157299 is administered orally twice daily for 14 days followed by 14 days without study drug (28 day cycle.) Gemcitabine 1000 milligram per square meter will be administered intravenously (IV) on Days 8, 15, and 22 in each cycle (28 day cycle). Participants may continue to receive treatment until discontinuation criteria are met. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2157299 | Drug | Administered orally |
| |
| Gemcitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with LY2157299 Dose-Limiting Toxicities (DLT) | Cycle 1 (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2157299 | Cycle 1: Predose on Day 1 through Day 28, Cycle 2 through last cycle: Predose on Day 1 (Cycle = 28 days; treatment estimated to last 4 cycles) | |
| PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2157299 |
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Inclusion Criteria:
Exclusion Criteria:
Are currently enrolled in, or discontinued within the last 30 days of study enrollment, a clinical trial involving an investigational product or nonapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have moderate or severe cardiac disease:
Have known positive tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus antibodies (HCVAbs).
Have symptomatic central nervous system (CNS) malignancy or metastasis.
Are unable to swallow tablets or capsules.
Are pregnant or breastfeeding.
Have serious preexisting medical conditions as follows:
Have previous or concurrent malignancy except for basal or squamous cell skin cancer (non-melanoma) and/or preinvasive carcinoma of the cervix, mucosal gastrointestinal or uterine carcinoma, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to enrollment.
Have endocrine pancreatic tumors or ampullary cancer.
Have current hematological malignancies.
Have previously completed or withdrawn from this study or any other study investigating LY2157299.
Have known allergies to LY2157299 or gemcitabine or any ingredient of LY2157299 or gemcitabine formulations.
Are assessed as inadequate for the study by the investigator.
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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. | Chiba | 277 8577 |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C557799 | LY-2157299 |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Drug |
Administered IV |
|
| Cycle 1: Predose on Day 1 through Day 28, Cycle 2 through last cycle: Predose on Day 1 (Cycle = 28 days; treatment estimated to last 4 cycles) |
| PK: Cmax of Gemcitabine | Cycle 1 (28 days): Predose on Day 8 through 2 hours after gemcitabine infusion on Day 8 |
| PK: AUC of Gemcitabine | Cycle 1 (28 days): Predose on Day 8 through 2 hours after gemcitabine infusion on Day 8 |
| Percentage of Participants with a Tumor Response | Baseline to study completion (estimated as 5 months) |
| Japan |
| 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 | Japan |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |