Acute Myeloid LeukemiaPhase 2NCT01066494
A Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Patients With Acute Myeloid Leukemia (AML)
A Phase 2 study testing Amonafide + cytarabine in people with Acute Myeloid Leukemia, run by Antisoma Research at 6 sites in 2 countries.
Trial summary
A phase IIa study to evaluate the pharmacokinetic and efficacy of amonafide L-malate (AS1413) in combination with cytarabine in treating patients with acute myeloid leukemia (AML) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Amonafide + cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2010to Jan 2011
- Phase
- Phase 2
- 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
- Willing and able to provide written informed consent
- In the opinion of the Investigator able to comply with the study assessments and follow-up
- New diagnosis of AML (i.e. >20 % blasts) as defined by the World Health Organization (WHO) classification (Vardiman 2009) or relapsed or refractory AML as defined by the persistence or recurrence of >5% blasts in bone marrow or peripheral blood following treatment.
- ECOG Performance status ≤ 2
- Age > 18 years and ≤ 70 years
- Adequate hepatic function as evidenced by the following laboratory tests:
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- Total serum bilirubin ≤ 1.5 x ULN or direct (conjugated) bilirubin ≤ 1.5 ULN unless attributable to suspected hepatic involvement with AML
- Serum AST and ALT ≤ 1.5 x ULN unless attributable to suspected hepatic involvement with AML
- Adequate renal function as evidenced by serum creatinine ≤ 1.5 x ULN
- Women of childbearing potential must have a negative serum pregnancy test. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives
- Left Ventricular Ejection Fraction (LVEF) > 50%, as determined by multiplegated acquisition scan (MUGA) or echocardiogram (ECHO) within 28 days prior to administration of 1st dose of remission induction chemotherapy
Who cannot join
- Unwilling to accept the required per protocol blood and urine sample collection
- An initial diagnosis of acute promyelocytic leukemia as defined by French- American-British criteria (Bennett 1976) (otherwise known as FAB M3)
- Clinically active CNS leukemia
- History of clinically significant allergic reactions attributed to compounds of similar chemical or biological composition to amonafide or cytarabine
- Pregnant or breast feeding
- Known HIV positive
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- Known active hepatitis B or C, or any other active liver disease
- Evidence of pulmonary infection. Patients with evidence of pulmonary infection on screening chest x-ray should have chest computed tomography (CT) prior to starting remission induction therapy to confirm absence or presence of pulmonary infection.
- Any major surgery or radiation therapy within 30 days prior to study entry
- Previously received treatment with amonafide
- Treatment with other investigational agents for any reason within 30 days prior to study entry
- Prior remission induction therapy for AML within 30 days of starting amonafide therapy
- Persistent non-hematologic toxicity (other than alopecia) greater than Grade 2 from prior therapy for MDS or AML
- Serious concomitant illnesses (for example, unstable angina or myocardial infarction or stroke within 3 months prior to study entry, congestive heart
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Georgia3 sites
Institute of Haematology and Transfusiology
Tbilisi, 0177
Medulla - Chemotherapy and Immunotherapy Clinic
Tbilisi, 0186
Hema - Haematology and Chemotherapy Clinic
Tbilisi
Ukraine3 sites
Institure of URgent adn Recovery Surgery n.a. V.K. gusaka of Academy Medical Science of Ukraine
Donetsk, 83045
Kyiv bone Marrow Transplantation Centre
Kiev, 03115
Vinnytsya Regional clinical Hospital
Vinnytsia, 21018
About this study
Official title: A Phase IIa Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Adult Patients With Acute Myeloid Leukemia (AML)
A phase IIa study to evaluate the pharmacokinetic and efficacy of amonafide L-malate (AS1413) in combination with cytarabine in treating patients with acute myeloid leukemia (AML)
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Amonafide + cytarabine
- Keywords
- AML, Pgp, MDR, sAML, AS1413, Amonafide
- 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.
Amonafide + cytarabineDrug
Amonafide 600 mg/m2 IV over 4 hours daily on days 1-5 in combination with cytarabine 200 mg/m2 IV continuous infusion (CI) daily on days 1-7
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Amonafide 600 mg/m2 IV over 4 hours daily on days 1-5 in combination with cytarabine 200 mg/m2 IV continuous infusion (CI) daily on days 1-7 Receives: Drug: Amonafide + cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the plasma PK Profile of amonafide and metabolite(s)
Measured: 1 year
To deine the urniary excretion of amonafide and metabolite(s)
Measured: 1 year
To investigate the fecal excretion of amonafide and metabolite(s) in selected patients
Measured: 1 year
To evaluate the safety and tolerability of amonafide in combination with cytarabine
Measured: 1 year
To evaluate the remission rate
Measured: 1 year
Secondary outcomes (1)
All outcomes are of equal weighting
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antisoma Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066494
- Sponsor's protocol ID
- AS1413-C-101
- Status last verified
- Jan 2011
- First submitted
- 9 Feb 2010
- Last updated
- 17 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Adult Patients With Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT01066494
- Acronym / sponsor ID
- AS1413-C-101
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, Pgp, MDR, sAML, AS1413, Amonafide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Antisoma ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 10 Feb 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.
A phase IIa study to evaluate the pharmacokinetic and efficacy of amonafide L-malate (AS1413) in combination with cytarabine in treating patients with acute myeloid leukemia (AML)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Drug: Amonafide + cytarabineAmonafide 600 mg/m2 IV over 4 hours daily on days 1-5 in combination with cytarabine 200 mg/m2 IV continuous infusion (CI) daily on days 1-7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Willing and able to provide written informed consent
- In the opinion of the Investigator able to comply with the study assessments and follow-up
- New diagnosis of AML (i.e. >20 % blasts) as defined by the World Health Organization (WHO) classification (Vardiman 2009) or relapsed or refractory AML as defined by the persistence or recurrence of >5% blasts in bone marrow or peripheral blood following treatment.
- ECOG Performance status ≤ 2
- Age > 18 years and ≤ 70 years
Key exclusion criteria (14 listed)
- Unwilling to accept the required per protocol blood and urine sample collection
- An initial diagnosis of acute promyelocytic leukemia as defined by French- American-British criteria (Bennett 1976) (otherwise known as FAB M3)
- Clinically active CNS leukemia
- History of clinically significant allergic reactions attributed to compounds of similar chemical or biological composition to amonafide or cytarabine
- Pregnant or breast feeding
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 |
|---|---|---|
| Amonafide + cytarabineAmonafide 600 mg/m2 IV over 4 hours daily on days 1-5 in combination with cytarabine 200 mg/m2 IV continuous infusion (CI) daily on days 1-7 | Drug | Single-arm |
Primary outcome
To define the plasma PK Profile of amonafide and metabolite(s)
Time frame: 1 year
To deine the urniary excretion of amonafide and metabolite(s)
Time frame: 1 year
To investigate the fecal excretion of amonafide and metabolite(s) in selected patients
Time frame: 1 year
To evaluate the safety and tolerability of amonafide in combination with cytarabine
Time frame: 1 year
To evaluate the remission rate
Time frame: 1 year
1 secondary outcome
All outcomes are of equal weighting
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amonafide + cytarabine in people with Acute Myeloid Leukemia, run by Antisoma Research 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 11 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 17 Jan 2011. 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 Georgia, Ukraine. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
To define the plasma PK Profile of amonafide and metabolite(s) (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2011.