An open, randomised clinical Phase I/IIa trial to investigate the maximum tolerated dose, efficacy, safety and pharmacokinetics of repeated three-week courses of a single dose i.v. BI 2536 on day 1 in comparison to single doses i.v. BI 2536 on days 1, 2 and 3 in patients over 60 years of age with refractory or relapsed acute myeloid leukaemia

• Conditions: Male or female patients older than 60 years of age with confirmed AML (except for APL) according to the WHO definition who relapsed after or are refractory to prior chemotherapy. Leukocyte count should be = 25,000 /µl (25 x 109/Liter). Patient should be not eligible for intensive treatment options. Patient should have a life expectancy = 2 months and Eastern co-operative oncology group performance score of 2 or less.

• Registration Number: EUCTR2006-000613-38-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-01
• Last Update Posted: 26 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Male or female patients older than 60 years of age
•Patient with confirmed AML (except for APL) according to the WHO definition who relapsed after or are refractory to prior chemotherapy
•Leukocyte count = 25,000 /µl (25 x 109/Liter)
•Patient not eligible for intensive treatment options
•Life expectancy = 2 months
•Eastern co-operative oncology group performance score of 2 or less
•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 acute promyelocytic leukaemia (APL, AML of the French-American-British (FAB) classification subtype M3)
•Hypersensitivity to the trial drug or the excipients
•Secondary malignancy requiring therapy
•Known central nervous system involvement
•Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal, or AST or ALT greater than 5 times the upper limit of normal in case of known liver involvement
•Bilirubin greater than 1.5 mg/dl (> 26 umol/l, SI unit equivalent)
•Serum creatinine greater than 2.0 mg/dl
•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 (see also section 4.2.2)
•Chemotherapy (except hydroxyurea, see section 4.2.2) or immunotherapy within the past two weeks prior to treatment with BI 2536
•Any other investigational drugs within a period of the drug's half-life x5 prior to treatment with BI 2536
•Persistence of toxicities of prior anti-leukaemia therapies which are deemed to be clinically relevant
•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.)
•Patient unable to comply with the protocol

Study & Design

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