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| ID | Type | Description | Link |
|---|---|---|---|
| I4D-MC-JTJL | Other Identifier | Eli Lilly and Company | |
| 2015-005611-33 | EudraCT Number |
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The main purpose of this study is to evaluate the safety of the study drug prexasertib in combination with ralimetinib in participants with advanced or metastatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: prexasertib + ralimetinib | Experimental | Cohort 1: 60 milligrams (mg) prexasertib (LY2606368) given intravenously (IV) and 100 mg ralimetinib given orally. Cohort 2: 60 mg prexasertib (LY2606368) given intravenously (IV) and 200 mg ralimetinib given orally. |
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| Part B1: prexasertib + ralimetinib (colorectal cancer) | Experimental | 60 mg prexasertib (LY2696368) given IV and 200 mg ralimetinib given orally. Participants receive prexasertib IV on Days 1 and 15 and ralimetinib every 12 hours (Q12H) Days 1 and 14 of a 28 day cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prexasertib | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib | Cycle 1 (28 Days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib | Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles) | |
| PK: Area Under the Curve (AUC) of Prexasertib | Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
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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 |
|---|---|---|---|---|---|---|
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States | ||
| Sarah Cannon Research Institute SCRI |
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| Label | URL |
|---|---|
| Click here for more information about this study: A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer | View source |
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| ralimetinib | Drug | Administered orally |
|
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| PK: Cmax of Ralimetinib | Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| PK: AUC of Ralimetinib | Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
| Best Overall Response (BOR): Percentage of Participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE) | Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Estimated up to 32 Weeks) |
| Disease Control Rate (DCR): Percentage of Participants who Exhibit SD, CR or PR | Baseline through Measured Progressive Disease (Estimated up to 32 Weeks) |
| Duration of Response (DOR) | Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 32 Weeks) |
| Progression Free Survival (PFS) | Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks) |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| 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. | Cologne | 50937 | Germany |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D015179 | Colorectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000608121 | prexasertib |
| C580958 | ralimetinib |
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