An open Phase I/IIa trial to investigate the maximum tolerated dose, safety, efficacy and pharmacokinetics of BI 811283 in combination with cytarabine in patients with previously untreated acute myeloid leukaemia ineligible for intensive treatment

• Conditions: Previously untreated acute myeloid leukaemia in adult patients that are not eligiblefor intensive treatment, and adult patients with relapsed or refractory acute myeloid leukaemia that are not eligible for intensive treatment; MedDRA version: 9.1Level: LLTClassification code 10000886Term: Acute myeloid leukemia

• Registration Number: EUCTR2007-005684-10-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-17
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

• For the phase I part: male or female adult with previously untreated AML (except hydroxyurea, see protocol section 4.2.2) or relapsed/refractory AML. For the phase IIa part: male or female adult with previously untreated AML (except hydroxyurea, see protocol section 4.2.2)
• 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 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patient with APL (AML subtype M3 according to the French-American-British
(FAB) classification)
• Relapsed or treatment refractory AML (for phase II part only)
• 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
• INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists
(phenprocoumon, warfarin)
• Bilirubin greater than 1.5 mg/dl (> 26 µmol/l, SI unit equivalent)
• 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 - 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)
• 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 spermacide, etc.)
• Pregnant or nursing female patients
• Patient unable to comply with the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified