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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02238925|
Recruitment Status : Completed
First Posted : September 12, 2014
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML) Acute Lymphoblastic Leukemia (ALL) Myelodysplastic Syndrome (MDS)||Drug: CPX-351||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||January 2016|
Single Arm Study (Patients may receive up to 2 Inductions and 4 Consolidations):
Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.
Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.
Consolidations 1-4: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.
- Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF) [ Time Frame: 21 days ]Time-matched QTcF Changes From Baseline after the start of first infusion
- Serum Copper Levels Change From Baseline [ Time Frame: During 1st induction (up to 5 days) ]Change from Baseline to Induction 1, Day 5
- Complete Response Rate [ Time Frame: Following 1st induction, following 2nd induction if applicable ]
- Tmax [ Time Frame: Induction 1, Day 5 ]
- Cmax [ Time Frame: Induction 1, Day 5 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238925
|United States, Indiana|
|Franciscan Saint Francis Health|
|Indianapolis, Indiana, United States, 46237|
|United States, Kansas|
|University of Kansas Cancer Center|
|Westwood, Kansas, United States, 66205|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|