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
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 /mcl (25 x 10e9/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
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 mcmol/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
- Chemotherapy (except hydroxyurea) or immunotherapy or treatment with any other
investigational drug within the past four weeks prior to treatment with the trial
drug
- 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 spermicide, etc.)
- Patient unable to comply with the protocol