An phase I/IIa trial to investigate the maximum tolerated dose, safety, pharmacokinetics, and efficacy of intraveneous BI 6727 as monotherapy or in combination with subcutaneous cytarabine in patients with acute myeloid leukaemia

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 143

Inclusion Criteria

•Male or female adult with relapsed/refractory AML ineligible for intensive treatment. (phase I part only)
•Male or female adult with previously untreated (except hydroxyurea) AML ineligible for intensive treatment (phase IIa part only)
•Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
•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 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

•Previously untreated AML (phase I part only)
•Relapsed or treatment refractory AML (phase IIa part only)
•Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification)
•Hypersensitivity to one of the trial drugs or the excipients
•Other malignancy requiring treatment
•Symptomatic central nervous system involvement
•Clinically relevant QT prolongation (e.g. long QT syndrome, QTcF > 470 ms)
•Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (ULN)
•Prothrombin time (PT) > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)
•Bilirubin greater than 1.5 mg/dl (> 26 µmol/L)
•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, cardiac arrhythmia or severe heart failure/cardiac insufficiency.
•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
•Contraindications for cytarabine treatment according to the SPC
•Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial, i.e. combination of two forms of effective contraception (hormonal contraception, intrauterine device, condom with spermicide, etc.). Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial
•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

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials