At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 26 enrolled
Drug / intervention
CPX-351drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Phase II Pharmacokinetic and Pharmacodynamic Assessment of the Potential for QTc Prolongation Following First Induction Treatment With CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Acute Leukemias and MDS Patients
In Brief
A Phase 2 clinical trial evaluating CPX-351 for Acute Myeloid Leukemia (AML) and 2 related conditions. Completed, enrolled 26 participants across 5 sites.
Detailed Summary
The purpose of this study is to assess the effects of CPX-351 on cardiac repolarization, assess plasma drug levels, asses serum copper levels, and assess drug levels in urine. Efficacy and Safety will be assessed in all patients enrolled to the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS)
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJul 2014
First PostedSep 2014
Primary CompletionMay 2015
Study CompletionJan 2016
TodayJul 2026
First PostedSep 12, 2014
Enrollment StartJul 1, 2014
Primary CompletionMay 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.8 years ago
Interventions
CPX-351drug