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poor accrual
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REMD-477 (Volagidemab) is a human anti-glucagon receptor antibody. Its proposed mechanism of action in controlling hyperglycemia is by blocking glucagon receptor (GCGR) signaling. In this way, it increases hepatic glucose uptake, decreases hepatic glycogenolysis and gluconeogenesis, increases glycogen synthesis, and ultimately decreases blood glucose levels. This protocol will test the hypotheses that REMD-477 is safe and tolerable in patients with severe hyperglycemia on copanlisib and that it decreases the risk of severe hyperglycemia in patients receiving copanlisib for relapsed refractory lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REMD-477 | Experimental | REMD-477 (human IgG2 anti-glucagon receptor antibody Volagidemab) will be administered as a subcutaneous injection for three weekly doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REMD-477 | Biological | REMD-477 will be administered as a subcutaneous injection for three weekly doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor | 22 days |
| Serious Adverse Events | Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase | 22 days |
| Liver Function Tests (LFT) units per liter (u/L) | Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase | 22 days |
| Blood Glucose measurements | Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase | 22 days |
| Pulse beats per minute | Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase | 22 days |
| breathing Rate breaths per minute | Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase | 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Glucose levels | Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia | 22 days |
| Insulin levels | Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000629677 | volagidemab |
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| 22 days |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |