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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Leukemia, Myeloid, Acute

Treatments: Drug: BI 811283 (d 1 and 15); Drug: Cytarabine; Drug: BI 811283 (d1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00632749

1247.3

2007-005684-10 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Schedule A

Experimental group

Description:

BI 811283 on days 1 and 15 in combination with Cytarabine 20 mg twice daily on Days 1-10

Treatment:

Drug: BI 811283 (d 1 and 15)

Drug: Cytarabine

Drug: Cytarabine

Schedule B

Experimental group

Description:

BI 811283 on Day 1 in combination with Cytarabine 20 mg twice daily on Days 1-10

Treatment:

Drug: Cytarabine

Drug: Cytarabine

Drug: BI 811283 (d1)