A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | October 2014 |
| End Date: | June 2020 |
| Contact: | Monica Wynn |
| Email: | mwynn@aptose.com |
| Phone: | 858-926-2737 |
A Phase Ib Dose Escalation and Expansion, Multicenter, Open-label, Safety, Pharmacokinetic and Pharmacodynamic Study of APTO-253 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia or High-Risk Myelodysplasia
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.
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 Ib 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.
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.
Inclusion Criteria:
- Patients ≥18 years old
- Life expectancy of at least 2 months
- Off previous cancer therapy for at least 14 days, or 5 half-lives for noncytotoxic
agents prior to first study treatment administration
- Patients must have a calculated creatinine clearance >60 mL/min
- Acceptable hematologic, renal and liver functions and coagulation status parameters
Exclusion Criteria:
- Patients with GVHD requiring systemic immunosuppressive therapy
- Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and
clinical significant disease related metabolic disorder
- Clinically significant intravascular coagulation
- Treatment with other investigational drugs within 14 days prior to first study
treatment administration
We found this trial at
7
sites
Orange, California 92868
Principal Investigator: Deepa Jeyakumar, MD
Phone: 877-827-8839
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201 Dowman Dr
Atlanta, Georgia 30303
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Martha Arellano, MD
Phone: 404-778-4334
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Patrick Burke, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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3310 Live Oak St
Dallas, Texas 75204
Dallas, Texas 75204
(214) 820-2687
Principal Investigator: Moshe Y. Levy, MD
Phone: 214-818-8325
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Houston, Texas 77030
Principal Investigator: Maro Ohanian, MD
Phone: 713-745-4642
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Tucson, Arizona 85724
Principal Investigator: Daruka Mahadevan, M.D
Phone: 520-694-1231
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