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

Primary Purpose

Leukemia, Myeloid, Acute

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 2536
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1216.20.43001 Boehringer Ingelheim Investigational Site
  • 1216.20.43002 Boehringer Ingelheim Investigational Site
  • 1216.20.49006 Boehringer Ingelheim Investigational Site
  • 1216.20.49002 Boehringer Ingelheim Investigational Site
  • 1216.20.49003 Boehringer Ingelheim Investigational Site
  • 1216.20.49004 Boehringer Ingelheim Investigational Site
  • 1216.20.49007 Boehringer Ingelheim Investigational Site
  • 1216.20.49005 Boehringer Ingelheim Investigational Site
  • 1216.20.49001 Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

Maximum tolerated dose Best objective response

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

Full Information

First Posted
June 18, 2008
Last Updated
April 30, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00701766
Brief Title
BI 2536 Infusional Treatment in Patients Over 60 Years of Age With Refractory or Relapsed Acute Myeloid Leukaemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BI 2536
Primary Outcome Measure Information:
Title
Maximum tolerated dose Best objective response
Time Frame
3 weeks, throughout the study period
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1216.20.43001 Boehringer Ingelheim Investigational Site
City
Innsbruck
Country
Austria
Facility Name
1216.20.43002 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1216.20.49006 Boehringer Ingelheim Investigational Site
City
Bonn
Country
Germany
Facility Name
1216.20.49002 Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
1216.20.49003 Boehringer Ingelheim Investigational Site
City
Freiburg
Country
Germany
Facility Name
1216.20.49004 Boehringer Ingelheim Investigational Site
City
Hannover-Heideviertel
Country
Germany
Facility Name
1216.20.49007 Boehringer Ingelheim Investigational Site
City
Heidelberg
Country
Germany
Facility Name
1216.20.49005 Boehringer Ingelheim Investigational Site
City
Münster
Country
Germany
Facility Name
1216.20.49001 Boehringer Ingelheim Investigational Site
City
Ulm
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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