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| ID | Type | Description | Link |
|---|---|---|---|
| H9H-JE-JBAN | 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 Japanese participants with advanced cancer or cancer that has spread to other parts of the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2157299 | Experimental | 80 up to 150 milligrams of LY2157299 administered orally, twice daily for 14 days, followed by 14 days with no study drug (2 weeks on/2 weeks off schedule) for at least two 28 day cycles. Participants receiving clinical benefit may continue receiving treatment until discontinuation criterion is met. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2157299 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose-Limiting Toxicities | Day 1 through Day 28 of Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299 | Days 1, 3, 6 and 14 of Cycle 1 and Days 1 and 14 of Cycle 2 | |
| Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY2157299 | Predose up to 6 hours postdose on Days 1 and 14 of Cycles 1 and 2 |
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Inclusion Criteria:
Exclusion Criteria:
Have moderate or severe cardiac disease:
Have current hematological malignancies.
Have central nervous system metastases.
Have serious preexisting medical conditions as follows;
Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies (HC Ab). Testing is not required unless circumstances warrant confirmation.
In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559 ) or 1-317-615-4559 Mon - Fri 9AM - 5PM 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 |
|---|---|---|---|
| 26526984 | Derived | Fujiwara Y, Nokihara H, Yamada Y, Yamamoto N, Sunami K, Utsumi H, Asou H, TakahashI O, Ogasawara K, Gueorguieva I, Tamura T. Phase 1 study of galunisertib, a TGF-beta receptor I kinase inhibitor, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Dec;76(6):1143-52. doi: 10.1007/s00280-015-2895-4. Epub 2015 Nov 3. |
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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 |
|---|---|
| C557799 | LY-2157299 |
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| Number of Participants with a Tumor Response | Baseline to study completion estimated at 16 weeks |
| Japan |