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| ID | Type | Description | Link |
|---|---|---|---|
| dalantercept | Other Identifier | USAN |
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For cancer cells to grow, they need to have nutrients supplied to them through blood vessels. The study drug, ACE-041, is designed to work by blocking the growth of those blood vessels and preventing cancer cells from growing. The purpose of this study is to establish safe dose levels of ACE-041 in patients with advanced solid tumors or relapsed/refractory multiple myeloma following multiple dose administration. This study will also evaluate if ACE-041 has an effect on tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACE-041 | Experimental | Patients assigned to 1 of 9 possible dosing groups |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACE-041 | Biological | Subcutaneous dose of ACE-041 approximately once every 3 weeks for a total of 4 doses. If disease stays the same or gets better, additional study drug may be offered. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of ACE-041 in patients with advanced solid tumors or relapsed/refractory multiple myeloma by monitoring adverse events, clinical laboratory tests, vital signs, physical examinations, and anti-drug antibody tests. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetic effect of ACE-041 through the collection of blood samples and to evaluate the preliminary anti-tumor activity of ACE-041 through tumor response evaluation, collection of blood biomarkers, and imaging techniques. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acceleron Investigative Site | Scottsdale | Arizona | United States | |||
| Acceleron Investigative Site |
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| Durham |
| North Carolina |
| United States |
| Acceleron Investigative Site | Nashville | Tennessee | United States |
| Acceleron Investigative Site | Salt Lake City | Utah | United States |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000591618 | ALK1-Fc fusion protein, human |
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