NCT00701766

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Last Updated

May 16, 2014

Status Verified

October 1, 2013

Enrollment Period

3 years

First QC Date

June 18, 2008

Last Update Submit

April 30, 2014

Conditions

Leukemia, Myeloid, Acute

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose Best objective response

    3 weeks, throughout the study period

Secondary Outcomes (1)

  • 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

Interventions

BI 2536DRUG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

1216.20.43001 Boehringer Ingelheim Investigational Site

Innsbruck, Austria

Location

1216.20.43002 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1216.20.49006 Boehringer Ingelheim Investigational Site

Bonn, Germany

Location

1216.20.49002 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1216.20.49003 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

1216.20.49004 Boehringer Ingelheim Investigational Site

Hannover-Heideviertel, Germany

Location

1216.20.49007 Boehringer Ingelheim Investigational Site

Heidelberg, Germany

Location

1216.20.49005 Boehringer Ingelheim Investigational Site

Münster, Germany

Location

1216.20.49001 Boehringer Ingelheim Investigational Site

Ulm, Germany

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

BI 2536

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 18, 2008

First Posted

June 19, 2008

Study Start

October 1, 2006

Primary Completion

October 1, 2009

Last Updated

May 16, 2014

Record last verified: 2013-10

Locations

DE(7)AU(2)