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| ID | Type | Description | Link |
|---|---|---|---|
| I4T-MC-JVDK | Other Identifier | Eli Lilly and Company | |
| 2015-004381-28 | EudraCT Number |
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The main purpose of this study is to evaluate the safety of ramucirumab in combination with other targeted agents in participants with advanced cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramucirumab + Merestinib | Experimental | Ramucirumab intravenously (IV) on day 1 and day 15 in combination with merestinib orally once a day over a 28 day cycle. Participants receiving benefit may continue until disease progression. |
|
| Ramucirumab + Abemaciclib | Experimental | Ramucirumab IV on day 1 and day 15 in combination with abemaciclib orally twice a day over a 28 day cycle. Participants receiving benefit may continue until disease progression. On June 21st 2017 the Ramucirumab + Abemaciclib arm was cancelled with no participants enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Cycle 1 (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab, Merestinib and Abemaciclib | Predose Cycle 1 Day 1 through Predose Cycle 6 Day 1 (28 day cycles) | |
| Proportion of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] |
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Inclusion Criteria:
Study Arm 1:
Study Arm 2
All Study Arms:
Exclusion Criteria:
Study Arm 1
Study Arm 2
All Arms:
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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 |
|---|---|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35249 | United States | ||
| University of Texas MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32537847 | Derived | Saleh M, Cassier PA, Eberst L, Naik G, Morris VK, Pant S, Terret C, Gao L, Long A, Mao H, McNeely S, Wagner EK, Carlesi RM, Fu S. Phase I Study of Ramucirumab Plus Merestinib in Previously Treated Metastatic Colorectal Cancer: Safety, Preliminary Efficacy, and Pharmacokinetic Findings. Oncologist. 2020 Nov;25(11):e1628-e1639. doi: 10.1634/theoncologist.2020-0520. Epub 2020 Jul 17. |
| Label | URL |
|---|---|
| Click here for more information about this study: A Study in Advanced Cancers Using Ramucirumab (LY3009806) and Other Targeted Agents | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| C586252 | merestinib |
| C000590451 | abemaciclib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Merestinib | Drug | Administered orally |
|
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| Abemaciclib | Drug | Administered orally |
|
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| Baseline through Measured Progressive Disease or Death (Estimated up to 24 months) |
| Progression Free Survival (PFS) | Baseline through Measured Progressive Disease or Death (Estimated up to 24 months) |
| Houston |
| Texas |
| 77030 |
| 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. | Lyon | 69373 | France |
| 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. | Marseille | 13385 | France |
| 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. | London | SE1 9RT | United Kingdom |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |