Status:
COMPLETED
The Pharmacokinetics and Cardiac Properties of Elacytarabine (CP-4055)
Lead Sponsor:
Clavis Pharma
Collaborating Sponsors:
Theradex
Syneos Health
Conditions:
Relapsed/Refractory AML
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of the study is to investigate the pharmacokinetics (PK) and cardiac properties of elacytarabine in patients with relapsed or refractory Acute Myeloid Leukaemia (AML). The efficacy and tol...
Detailed Description
Elacytarabine is an investigational drug which is not commercially available. It consists of a fatty acid that is connected to cytarabine which is commonly used in treatment of AML. Due to the connect...
Eligibility Criteria
Inclusion
- Inclusion¨Criteria:
- Patients must have relapsed / refractory AML according to WHO classification (excluding acute promyelocytic leukaemia)
- Patients must have ECOG Performance Status (PS) of 0 - 2
- Patients must be 18 years of age or older
- Women of child-bearing potential must have a negative serum or urine pregnancy test within two weeks prior to treatment start
- Male and female fertile patients must use adequate contraception for the duration of the study, and males also for 3 months after the last elacytarabine dose
- Patients must be capable of understanding and complying with protocol requirements, and they must be able and willing to sign a written informed consent
- Exclusion Criteria:
- A history of allergic reactions to egg. A history of CTCAE grade 3 or 4 allergic reactions to ara-C of
- A history of cancer that according to the investigator might confound the assessment of the endpoints of the clinical study
- Known positive status for human immunodeficiency virus (HIV)
- Pregnant and nursing patients
- Uncontrolled inter-current illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that will limit compliance with study requirements
- Impairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into the clinical study
- Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medications, or uncontrolled congestive heart failure. Any NYHA grade 3 or 4
- A history of familial long QT syndrome
- Patients with history of serious ventricular arrhythmia (VT or VT)
- ECG criteria at the eligibility visit: QTc ≥ 480 msec calculated using Fridericia's correction (QTcF = QT/RRO,33) or bradycardia (\<50bpm) or criteria for left ventricular hypertrophy
- treatment with any medications known to produce QT prolongations
- Treatment with hydroxyurea or 6-mercaptopurine within the last 12 hours prior to treatment on this protocol or any other investigational or standard cytotoxic treatment within the last 14 days
- 9\. Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01258816
Start Date
October 1 2010
End Date
June 1 2013
Last Update
September 23 2013
Active Locations (6)
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1
ICO - Hospital Duran i Reynals
Barcelona, Catalonia, Spain, 08907
2
Hospital General de la Vall d' Hebron
Barcelona, Spain, 08035
3
Hospital San Pedro Alcantara
Cáceres, Spain, 10003
4
Brighton & Sussex University Hospitals NHS Trust
Brighton, United Kingdom, BN2 5BE