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Part B of the study was terminated early due to a lack of enrollment.
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This study has two parts (A and B). The primary purpose of Part A is to find the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a twice a week basis. For Part B, an additional 20 patients will be treated at the maximum dose identified in Part A. AZD4877 is an Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4877 | Drug | intravenous infusion administered twice a week for 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities | on a twice a week schedule for two weeks out of every three weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of AZD4877 by assessment of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE) grade and type of AE, changes in laboratory values, vital signs, and incidence of protocol defined dose modification | assessed after each course of treatment | |
| Dose Expansion (Part B):Estimate efficacy of AZD4877 through evaluation of objective response rate, progression-free survival and disease control rate in patients with B-cell non-Hodgkin lymphoma using the revised response criteria for malignant lymphoma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Skolnik, MD | AstraZeneca | Study Director |
| Lea Burke | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | New York | New York | United States | |||
| Research Site |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C568512 | N-(3-aminopropyl)-N-(1-(5-benzyl-3-methyl-4-oxo-(1,2)thiazolo(5,4-d)pyrimidin-6-yl)-2-methylpropyl)-4-methylbenzamide |
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| Assessed during treatment and post treatment |
| Philadelphia |
| Pennsylvania |
| United States |
| Research Site | Greenville | South Carolina | United States |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |