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| ID | Type | Description | Link |
|---|---|---|---|
| CP15-0601 | Other Identifier | ImClone, LLC | |
| I5B-IE-JGDC | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine if IMC-3G3 is safe for patients, and also to determine the best dose of IMC-3G3 to give to patients.
The purpose of this study is to establish the safety profile and maximum tolerated dose (MTD) of the anti-PDGFRα monoclonal antibody IMC-3G3 in patients with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-3G3 | Experimental | All patients will receive intravenous infusions of IMC-3G3, with the dose depending on which cohort they are enrolled into. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-3G3 | Biological | Intravenously, once every week for Cohorts 1 through 3 and once every other week for Cohorts 4 and 5. Starting dose will be 4mg/kg in Cohort 1, with dose doubling between cohorts. Dose escalation of 100% (2 x previous dose) Dose escalation increment reduced to 33% (1.33 x previous dose). Cohorts 4 and 5 will receive 15mg/kg and 20mg/kg, intravenously, once every other week. |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Participants Reporting Adverse Events | Approximately 36 months | |
| Maximum Tolerated Dose (MTD) | After all patients complete a cohort, toxicity data is reviewed before the next cohort of patients is treated at the next higher dose level | Approximately 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | 6 weeks | |
| Anti-IMC-3G3 Antibody Assessment | Approximately 36 months | |
| Antitumor Activity of IMC-3G3 as Monotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E-mail: ClinicalTrials@ ImClone.com | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Indianapolis | Indiana | 46282 | United States | ||
| ImClone Investigational Site |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000589393 | olaratumab |
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|
| 6 weeks |
| Pharmacodynamics | 6 weeks |
| Houston |
| Texas |
| 77030 |
| United States |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |