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| ID | Type | Description | Link |
|---|---|---|---|
| I4D-JE-JTJK | Other Identifier | Eli Lilly and Company |
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The primary purpose of this study is to assess the tolerability of prexasertib in Japanese participants with advanced solid cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prexasertib | Experimental | Prexasertib intravenously (IV) on day 1 of a 14 day cycle. Treatment with prexasertib may continue until disease progression, unacceptable toxicity, or other discontinuation criteria are met. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prexasertib | Drug | Administered IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Prexasertib Dose-Limiting Toxicities (DLT) | Cycle 1 (14 day cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib | Pre-dose up to 7 Days Post Treatment in Cycle 1/2 (Approximately 7 Days) | |
| Pharmacokinetics (PK): Area Under Curve (AUC) of Prexasertib | Pre-dose up to 7 Days Post Treatment in Cycle1/2 (Approximately 7 Days) |
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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 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 | 277 8577 |
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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 |
|---|---|
| C000608121 | prexasertib |
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| Percentage of Participants with a Tumor Response | Baseline to Study Completion (Approximately 24 weeks) |
| 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 |