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| ID | Type | Description | Link |
|---|---|---|---|
| I4D-EW-JTJG | Other Identifier | Eli Lilly and Company | |
| 2015-003126-13 | EudraCT Number |
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The main purpose of this study is to evaluate the safety of the study drug known as Prexasertib (LY2606368) in participants with advanced cancer or cancer that has spread to other parts of the body. This study will involve a single dose of ¹⁴C radiolabelled Prexasertib . This means that a radioactive substance, carbon 14, will be incorporated into the study drug. This will provide information about the study drug and its breakdown products and will help determine how much passes from the blood into urine, feces and expired air. After a minimum 14-day washout period following the [¹⁴C] Prexasertib dose, participants will be allowed to receive continued access to Prexasertib as outpatients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [¹⁴C]Prexasertib | Experimental | 170 milligrams (mg) of prexasertib containing approximately 50 μCi [¹⁴C] prexasertib radiotracer administered intravenously (IV) as a 1 hour continuous IV infusion. |
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| Prexasertib | Experimental | 105 milligrams per square meter (mg/m²) of prexasertib administered IV as a 1 hour continuous IV infusion once every 14 days (14 day cycles). Treatment may continue until discontinuation criteria are met. Treatment for this arm was administered after ¹⁴C administration (¹⁴C was administered during first phase of the study) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [¹⁴C]Prexasertib | Drug | Administered IV Infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Urinary Excretion of LY2606368 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Baseline through 120 hours after administration of study drug | |
| Fecal Excretion of LY2606368 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Baseline through 120 hours after administration of study drug | |
| LY2606368 Radioactivity in Expired Air Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Baseline through 120 hours after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2606368 and Radioactivity | Predose through 120 hours after administration of study drug | |
| Pharmacokinetics: Area Under the Concentration Time Curve from Time Zero to the Last Measured Concentration (AUC0-tlast) of LY2606368 and Radioactivity |
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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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Liverpool | United Kingdom |
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| Label | URL |
|---|---|
| Click here for more information about this study: A Study of LY2606368 in Participants With Advanced Cancer | View source |
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| ID | Term |
|---|---|
| C000608121 | prexasertib |
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| Prexasertib | Drug | Administered IV Infusion |
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| Predose through 120 hours after administration of study drug |
| Pharmacokinetics: Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-∞) of LY2606368 and Radioactivity | Predose through 120 hours after administration of study drug |
| Relative Abundance of LY2606368 As Measured by Percentage of Radioactivity in Feces and Urine | Baseline through 120 hours after administration of study drug |