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| ID | Type | Description | Link |
|---|---|---|---|
| I4C-JE-JTBD | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to assess the safety and tolerability of LY2875358 in Japanese participants with cancer that is advanced and/or may have spread to another part of the body.
This study has 3 parts. Participants may only enroll in one part.
Part A - Participants will receive LY2875358.
Part B1 - Participants with non-small cell lung cancer (NSCLC) will receive LY2875358 and erlotinib.
Part B2 - Participants with NSCLC will receive LY2875358 and gefitinib.
Parts B1 and B2 were added per protocol amendment in January, 2013.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2875358 | Experimental | Part A. LY2875358 will be administered intravenously (IV) at escalating doses (700 mg up to 2000 mg) on Day 1 and Day 15 of a 28-day cycle, until any discontinuation criterion is met. |
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| LY2875358+Erlotinib | Experimental | Part B1. Erlotinib will be administered orally at 150 mg dose level each day. LY2875358 will be administered intravenously (IV) at recommended dose level in Part A on Day 1 and Day 15 of a 28-day cycle. (Part B1 was added per protocol amendment in January, 2013.) |
|
| LY2875358+Gefitinib | Experimental | Part B2. Gefitinib will be administered orally at 250 mg dose level each day. LY2875358 will be administered intravenously (IV) at recommended dose level in Part A on Day 1 and Day 15 of a 28-day cycle. (Part B2 was added per protocol amendment in January, 2013.) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2875358 | Biological | Administered IV |
| |
| Erlotinib |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with one or more drug (or procedure)-related adverse events (AEs) or any serious AEs | Baseline up to 56 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum concentration (Cmax) of LY2875358, erlotinib and gefitinib | Predose up to Cycle 6 | |
| Pharmacokinetics (PK): Area under the concentration time curve (AUC) of LY2875358, erlotinib and gefitinib | Predose up to Cycle 6 |
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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 |
|---|---|
| D008223 | Lymphoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000599789 | emibetuzumab |
| D000069347 | Erlotinib Hydrochloride |
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Administered orally |
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| Gefitinib | Drug | Administered orally |
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| Number of participants with a tumor response | Baseline to study completion (estimated to be 5 months) |
| Japan |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |