Trials / Terminated
TerminatedNCT02267863
A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS
A Phase Ia/b 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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Aptose Biosciences Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Acute Myelogenous Leukemia in Relapse
- Acute Myelogenous Leukemia, Relapsed, Adult
- Acute Myelogenous Leukemia, Adult
- Acute Myelogenous Leukemia
- High Risk Myelodysplasia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | APTO-253 | APTO-253 will be given in ascending doses starting at 20 mg/m2 until the maximum tolerated dose or recommended dose is reached. |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2021-09-01
- Completion
- 2021-09-01
- First posted
- 2014-10-20
- Last updated
- 2022-08-22
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02267863. Inclusion in this directory is not an endorsement.