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The purpose of this study is to determine the safety and maximum tolerated dose, pharmacokinetics, and anti-neoplastic response of AVN-944 in patients with advanced hematologic malignancies.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVN-944 capsules for oral administration | Drug |
Inclusion Criteria:
Histologically or cytologically confirmed chronic myelogenous leukemia, acute myeloid leukemia, acute lymphocytic leukemia, multiple myeloma, Waldenstrom's macroglobulinemia, non-Hodgkin's lymphoma or Hodgkin's disease.
Patients must be refractory to, intolerant of, or decline to receive established therapy known to provide clinical benefit for their condition.
Age > 18 years
ECOG performance score of 0 or 1
Adequate renal function as evidenced by serum creatinine < 2.0 mg/dL
Adequate hepatic function as evidenced by:
Patients must be recovered from the clinically significant effects of any prior surgery, radiotherapy or other antineoplastic therapy.
Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.
Women of childbearing potential as well as fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | United States | ||
| Stanford Cancer Center |
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| Stanford |
| California |
| 94305 |
| United States |
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
| Ohio State University, James Cancer Hospital Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Oregon Health and Science University | Portland | Oregon | 097239 | United States |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D008258 | Waldenstrom Macroglobulinemia |
| 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 |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C526922 | AVN 944 |
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