Relapsed/Refractory AMLPhase 1NCT01258816
The Pharmacokinetics and Cardiac Properties of Elacytarabine (CP-4055)
A Phase 1 study testing Elacytarabine for infusion in people with Relapsed/Refractory AML, run by Clavis Pharma at 6 sites in 2 countries.
Trial 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 tolerability of elacytarabine will also be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory AML
- What is being tested?
- Elacytarabine for infusion
- Type of treatment
- Injection or infusion
- How many people
- 43 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2010to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Spain3 sites
ICO - Hospital Duran i Reynals
Barcelona, Catalonia, 08907
Hospital General de la Vall d' Hebron
Barcelona, 08035
Hospital San Pedro Alcantara
Cáceres, 10003
United Kingdom3 sites
Brighton & Sussex University Hospitals NHS Trust
Brighton, BN2 5BE
University Hospital of Wales, Cardiff
Cardiff, CF14 4XW
St Bartholomew's Hospital
London, EC1A 7BE
About this study
Official title: A Phase I Study of the Human Pharmacokinetics and Cardiac Safety of Elacytarabine
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 tolerability of elacytarabine will also be assessed.
Read the 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 connection to a fatty acid, elacytarabine might have an increased uptake in blast cells and thereby increased efficacy.
The characterisation of the pharmacokinetics of an investigational drug, as well as the cardiac safety are essential. The PK of both elacytarabine and its metabolites will be assessed at defined timepoints before, during and after infusion. The cardiac safety of elacytarabine will be evaluated by triplicate ECG recordings at the same time points as the PK assessments.
Elacytarabine will be given as a continuous infusion for 5 days. The patients may continue with further courses of elacytarabine as long as the patient benefits from treatment with elacytarabine.
- Conditions
- Relapsed/Refractory AML
- Being tested
- Elacytarabine for infusion
- Keywords
- Acute Myeloid Leukaemia (AML), Pharmacokinetics, Elacytarabine, CP-4055
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elacytarabine for infusionDrug
Also called CP-4055
Elacytarabine 2000 mg/m2/d will be administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w schedule.
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterise the pharmacokinetics of elacytarabine in patients with relapsed/refractory Acute Myeloid Leukaemia
Collection of pheripheral blood samples at specified time points during first week of the treatment course for PK analyses
Measured: During first week of treatment course
Secondary outcomes (3)
Investigate the activity of elacytarabine measured as remission rate (CR + CRi)
Bone marrow and/or blood examination
Measured: After each course
Number of patients with Adverse Events as a measure of safety and tolerability
Measured: Continuously during study
Evaluate the cardiac safety of elacytarabine with focus on the QT/QTc intervals
Triplicate 12-lead ECG assessments will be done at specified time points before, during and after infusion
Measured: During the first week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed/Refractory AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clavis Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theradex, Syneos Health, CardiaBase, Learn & Confirm
- Responsible party
- Sponsor
- Investigators
- Steven Knapper, MD, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258816
- Sponsor's protocol ID
- CP4055-109
- Status last verified
- Sep 2013
- First submitted
- 26 Nov 2010
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Knapper S, Chevassut T, Duarte R, Bergua JM, Salamero O, Johansen M, Jacobsen TF, Hals PA, Rasch W, Gianella-Borradori A, Smith M. Elacytarabine in relapsed/refractory acute myeloid leukaemia: an evaluation of clinical efficacy, pharmacokinetics, cardiac safety and effects on lipid profile. Leuk Res. 2014 Mar;38(3):346-51. doi: 10.1016/j.leukres.2013.12.011. Epub 2013 Dec 25.
PubMed 24433865
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Human Pharmacokinetics and Cardiac Safety of Elacytarabine
- ClinicalTrials.gov ID
- NCT01258816
- Acronym / sponsor ID
- CP4055-109
- Conditions
- Relapsed/Refractory AML
- Keywords
- Acute Myeloid Leukaemia (AML), Pharmacokinetics, Elacytarabine, CP-4055
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Clavis PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Theradex, Syneos Health, CardiaBase, Learn & Confirm
- Study start
- Oct 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 tolerability of elacytarabine will also be assessed.
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 connection to a fatty acid, elacytarabine might have an increased uptake in blast cells and thereby increased efficacy.
The characterisation of the pharmacokinetics of an investigational drug, as well as the cardiac safety are essential. The PK of both elacytarabine and its metabolites will be assessed at defined timepoints before, during and after infusion. The cardiac safety of elacytarabine will be evaluated by triplicate ECG recordings at the same time points as the PK assessments.
Elacytarabine will be given as a continuous infusion for 5 days. The patients may continue with further courses of elacytarabine as long as the patient benefits from treatment with elacytarabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elacytarabine for infusionAlso: CP-4055Elacytarabine 2000 mg/m2/d will be administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w schedule. | Drug | – |
Primary outcome
Characterise the pharmacokinetics of elacytarabine in patients with relapsed/refractory Acute Myeloid Leukaemia
Time frame: During first week of treatment course
Collection of pheripheral blood samples at specified time points during first week of the treatment course for PK analyses
3 secondary outcomes
Investigate the activity of elacytarabine measured as remission rate (CR + CRi)
Time frame: After each course
Number of patients with Adverse Events as a measure of safety and tolerability
Time frame: Continuously during study
Evaluate the cardiac safety of elacytarabine with focus on the QT/QTc intervals
Time frame: During the first week of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
- Derived from this study: PubMed 24433865Knapper S, Chevassut T, Duarte R, Bergua JM, Salamero O, Johansen M, Jacobsen TF, Hals PA, Rasch W, Gianella-Borradori A, Smith M. Elacytarabine in relapsed/refractory acute myeloid leukaemia: an evaluation of clinical efficacy, pharmacokinetics, cardiac safety and effects on lipid profile. Leuk Res. 2014 Mar;38(3):346-51. doi: 10.1016/j.leukres.2013.12.011. Epub 2013 Dec 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Knapper, MD principal investigator
Cardiff University
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elacytarabine for infusion in people with Relapsed/Refractory AML, run by Clavis Pharma at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterise the pharmacokinetics of elacytarabine in patients with relapsed/refractory Acute Myeloid Leukaemia (time frame: During first week of treatment course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01258816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2013.