BI 2536 Infusional Treatment in Patients Over 60 Years of Age With Refractory or Relapsed Acute Myeloid Leukaemia

Leukemia, Myeloid, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701766
• Other study ID #: 1216.20
• Secondary ID: EudraCT No:2006-
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2008
• Last updated: April 30, 2014
• Start date: October 2006

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareGermany: Bundesinstitut fuer Arzneimittel und Medizinprodukte
• Study type: Interventional

Clinical Trial Summary

The present trial will be performed to determine the MTD and to evaluate the efficacy of BI 2536 in the treatment of elderly patients with relapsed or refractory AML. Different schedules will be compared to identify the better dosing schedule for the further development programme of BI 2536. Dose escalation starting with the maximum tolerated dose previously determined in patients with advanced solid cancers will be performed to determine the maximum tolerated dose for AML patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• BI 2536

Locations

Country	Name	City	State
Austria	1216.20.43001 Boehringer Ingelheim Investigational Site	Innsbruck
Austria	1216.20.43002 Boehringer Ingelheim Investigational Site	Wien
Germany	1216.20.49006 Boehringer Ingelheim Investigational Site	Bonn
Germany	1216.20.49002 Boehringer Ingelheim Investigational Site	Frankfurt
Germany	1216.20.49003 Boehringer Ingelheim Investigational Site	Freiburg
Germany	1216.20.49004 Boehringer Ingelheim Investigational Site	Hannover-Heideviertel
Germany	1216.20.49007 Boehringer Ingelheim Investigational Site	Heidelberg
Germany	1216.20.49005 Boehringer Ingelheim Investigational Site	Münster
Germany	1216.20.49001 Boehringer Ingelheim Investigational Site	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose Best objective response		3 weeks, throughout the study period
Secondary	Event free survival, Overall survival, Remission duration, BI 2536 plasma concentrations, Incidence and intensity of adverse events graded according to CTCAE, PD, Incidence of DLT		throughout the study period