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Drug manufacturing process and procedure review
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This study is being done to evaluate the safety and effectiveness of APTO-253 for the treatment of patients with the condition of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.
This is a multicenter, open-label, Phase Ia/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of APTO-253 in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory acute myelogenous leukemia (AML) or high-risk MDS patients. This is to be followed by a cohort expansion phase at the MTD or recommended dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation and Expansion | Experimental | APTO-253 will be given in ascending doses in patients with relapsed or refractory AML or high risk MDS (escalation cohort), until the maximum tolerated dose or recommended dose is reached. Followed by up to 30 patients enrolled in the expansion cohort at the recommended dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APTO-253 | Drug | APTO-253 will be given in ascending doses starting at 20 mg/m2 until the maximum tolerated dose or recommended dose is reached. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events of APTO-253 | To determine the safety and tolerability of APTO-253 by assessing treatment-related adverse events as assessed by CTCAE v4.0. | Cycle 1 (28 days) |
| Maximum tolerated dose and dose limiting toxicities | To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of APTO-253 when given on days 1, 8, 15, and 22 of each 28-day cycle. | Cycle 1 (28 days) |
| Establish recommended dose for future development of APTO-253 | To establish the dose of APTO-253 recommended for future development of APTO-253 for patients with specific types of hematologic malignancies. | Up to 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables including maximum plasma concentration (Cmax) | Pharmacokinetic variables including maximum plasma concentration (Cmax) | Cycle 1 (28 days) |
| Pharmacokinetic variables including minimum plasma concentration (Cmin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafael Bejar, MD., PhD. | Aptose Biosciences Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85724 | United States | ||
| UC San Diego Moores Cancer Center |
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| Label | URL |
|---|---|
| Aptose Biosciences | View source |
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Pharmacokinetic variables including minimum plasma concentration (Cmin)
| Cycle 1 (28 days) |
| Pharmacokinetic variables including Area Under the Curve (AUC) | Pharmacokinetic variables including Area Under the Curve (AUC) | Cycle 1 (28 days) |
| Pharmacokinetic variables including volume of distribution | Pharmacokinetic variables including volume of distribution | Cycle 1 (28 days) |
| Pharmacokinetic variables including clearance | Pharmacokinetic variables including clearance | Cycle 1 (28 days) |
| Pharmacokinetic variables including serum half-life | Pharmacokinetic variables including serum half-life | Cycle 1 (28 days) |
| Assess for any evidence of antitumor activity of APTO-253 by hematologic and bone marrow evaluations in acute leukemia and MDS. | To observe patients for any evidence of antitumor activity of APTO-253 by hematologic and bone marrow evaluations in acute leukemia and MDS. | Average 2 Cycles (8 weeks) |
| Determine the ability of APTO-253 to alter the expression of pharmacodynamic biomarkers of drug effect. | To determine the ability of APTO-253 to alter the expression of pharmacodynamic biomarkers of drug effect. | Average 2 Cycles (8 weeks) |
| La Jolla |
| California |
| 92093-0698 |
| United States |
| University of California, Irvine | Orange | California | 92868 | United States |
| Emory University; Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Ochsner Cancer Institute | New Orleans | Louisiana | 70121 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| St. Vincent Frontier Cancer Center | Billings | Montana | 59102 | United States |
| University of Rochester; Wilmot Cancer Institute Clinical Trials Office | Rochester | New York | 14643 | United States |
| University Hospital | Cleveland | Ohio | 44106 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Prisma Health, Institute for Translational Oncology Research | Greenville | South Carolina | 29605 | United States |
| Baylor Research Institute | Dallas | Texas | 75246 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D012008 | Recurrence |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000608520 | APTO-253 |
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