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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


Phase 2
60 Years
N/A
Not Enrolling
Both
Leukemia, Myeloid, Acute

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose Best objective response

Outcome Time Frame:

3 weeks, throughout the study period

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

1216.20

NCT ID:

NCT00701766

Start Date:

October 2006

Completion Date:

Related Keywords:

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

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