Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Leukemia, Myeloid, Acute

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Investigation of maximum tolerated dose, safety, efficacy and pharmcokinetics of BI 811283 in combination with cytarabine (LD-Ara-C) in previously untreated acute myeloid leukaemia (AML) patients

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Male or female adult with previously untreated acute myeloid leukaemia (AML)
  • Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
  • Patient is considered ineligible for intensive treatment
  • Patient is eligible for low-dose cytarabine (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
  • Exclusion criteria:
  • Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).
  • Relapsed or treatment refractory AML.
  • Hypersensitivity to one of the trial drugs or the excipients.
  • Other malignancy requiring treatment.
  • Known central nervous system involvement.
  • Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (ULN).
  • INR \> 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).
  • Bilirubin greater than 1.5 mg/dl.
  • Serum creatinine greater than 2.0 mg/dl.
  • LVEF (Left ventricular ejection fraction) \< 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.
  • 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 (i.e. other chemo- or immunotherapy, see also section 4.2.2).
  • Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).
  • 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.).
  • Pregnant or nursing female patients.
  • Patient unable to comply with the protocol.

Exclusion

    Key Trial Info

    Start Date :

    May 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2014

    Estimated Enrollment :

    68 Patients enrolled

    Trial Details

    Trial ID

    NCT00632749

    Start Date

    May 1 2008

    End Date

    March 1 2014

    Last Update

    September 14 2015

    Active Locations (7)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    1

    1247.3.49007 Boehringer Ingelheim Investigational Site

    Berlin, Germany

    2

    1247.3.49005 Boehringer Ingelheim Investigational Site

    Frankfurt am Main, Germany

    3

    1247.3.49004 Boehringer Ingelheim Investigational Site

    Freiburg im Breisgau, Germany

    4

    1247.3.49006 Boehringer Ingelheim Investigational Site

    Hamburg, Germany