Overview

This trial is active, not recruiting.

Condition acute myeloid leukemia
Treatment amonafide + cytarabine
Phase phase 2
Sponsor Antisoma Research
Start date January 2010
End date September 2010
Trial size 20 participants
Trial identifier NCT01066494, AS1413-C-101

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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
amonafide + cytarabine
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

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
All outcomes are of equal weighting
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Willing and able to provide written informed consent 2. In the opinion of the Investigator able to comply with the study assessments and follow-up 3. 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. 4. ECOG Performance status ≤ 2 5. Age > 18 years and ≤ 70 years 6. Adequate hepatic function as evidenced by the following laboratory tests: 1. Total serum bilirubin ≤ 1.5 x ULN or direct (conjugated) bilirubin ≤ 1.5 ULN unless attributable to suspected hepatic involvement with AML 2. Serum AST and ALT ≤ 1.5 x ULN unless attributable to suspected hepatic involvement with AML 7. Adequate renal function as evidenced by serum creatinine ≤ 1.5 x ULN 8. 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 9. 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 Exclusion Criteria: 1. Unwilling to accept the required per protocol blood and urine sample collection 2. An initial diagnosis of acute promyelocytic leukemia as defined by French- American-British criteria (Bennett 1976) (otherwise known as FAB M3) 3. Clinically active CNS leukemia 4. History of clinically significant allergic reactions attributed to compounds of similar chemical or biological composition to amonafide or cytarabine 5. Pregnant or breast feeding 6. Known HIV positive 7. Known active hepatitis B or C, or any other active liver disease 8. 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. 9. Any major surgery or radiation therapy within 30 days prior to study entry 10. Previously received treatment with amonafide 11. Treatment with other investigational agents for any reason within 30 days prior to study entry 12. Prior remission induction therapy for AML within 30 days of starting amonafide therapy 13. Persistent non-hematologic toxicity (other than alopecia) greater than Grade 2 from prior therapy for MDS or AML 14. Serious concomitant illnesses (for example, unstable angina or myocardial infarction or stroke within 3 months prior to study entry, congestive heart

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Antisoma Research.