BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigation of maximum tolerated dose, safety, efficacy and pharmcokinetics of BI 811283 in combination with cytarabine (LD-Ara-C) in previously untreated acute myeloid leukaemia (AML) patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Cytarabine

Criteria

Inclusion criteria:

• Male or female adult with previously untreated acute myeloid leukaemia (AML)

• Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)

• Patient is considered ineligible for intensive treatment

• Patient is eligible for low-dose cytarabine (LD-Ara-C) treatment

• Life expectancy > 3 months

• Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at screening

• Signed written informed consent consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation

Exclusion criteria:

• Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).

• Relapsed or treatment refractory AML.

• Hypersensitivity to one of the trial drugs or the excipients.

• Other malignancy requiring treatment.

• Known central nervous system involvement.

• Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (ULN).

• INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).

• Bilirubin greater than 1.5 mg/dl.

• Serum creatinine greater than 2.0 mg/dl.

• LVEF (Left ventricular ejection fraction) < 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.

• Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia.

• Psychiatric illness or social situation that would limit compliance with trial requirements.

• Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy, see also section 4.2.2).

• Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).

• Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.).

• Pregnant or nursing female patients.

• Patient unable to comply with the protocol.