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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00701766
First received: June 18, 2008
Last updated: April 30, 2014
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Leukemia, Myeloid, Acute
Drug: BI 2536
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Maximum tolerated dose Best objective response [ Time Frame: 3 weeks, throughout the study period ]

Secondary Outcome Measures:
  • 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 [ Time Frame: throughout the study period ]

Enrollment: 71
Study Start Date: October 2006
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701766

Locations
Austria
1216.20.43001 Boehringer Ingelheim Investigational Site
Innsbruck, Austria
1216.20.43002 Boehringer Ingelheim Investigational Site
Wien, Austria
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, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00701766     History of Changes
Other Study ID Numbers: 1216.20, EudraCT No:2006-000613-38
Study First Received: June 18, 2008
Last Updated: April 30, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 21, 2014