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

NCT ID: NCT00632749

Last Updated: 2015-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2014-03-31

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

Conditions

Leukemia, Myeloid, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Schedule A

BI 811283 on days 1 and 15 in combination with Cytarabine 20 mg twice daily on Days 1-10

Group Type: EXPERIMENTAL

BI 811283 (d 1 and 15)

Intervention Type: DRUG

BI 811283 (24 hours i.v.c.i.) on day 1 and 15 of a 4-week treatment cycle

Cytarabine

Intervention Type: DRUG

Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle

Schedule B

BI 811283 on Day 1 in combination with Cytarabine 20 mg twice daily on Days 1-10

Group Type: EXPERIMENTAL

Cytarabine

Intervention Type: DRUG

Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle

BI 811283 (d1)

Intervention Type: DRUG

BI 811283 (24 hours i.v.c.i.) on day 1 of a 4-week treatment cycle

Interventions

BI 811283 (d 1 and 15)

BI 811283 (24 hours i.v.c.i.) on day 1 and 15 of a 4-week treatment cycle

Intervention Type: DRUG

Cytarabine

Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle

Intervention Type: DRUG

BI 811283 (d1)

BI 811283 (24 hours i.v.c.i.) on day 1 of a 4-week treatment cycle

Intervention Type: DRUG

Cytarabine

Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1247.3.49007 Boehringer Ingelheim Investigational Site

Berlin, , Germany

1247.3.49005 Boehringer Ingelheim Investigational Site

Frankfurt am Main, , Germany

1247.3.49004 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

1247.3.49006 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

1247.3.49003 Boehringer Ingelheim Investigational Site

Heidelberg, , Germany

1247.3.49002 Boehringer Ingelheim Investigational Site

Münster, , Germany

1247.3.49001 Boehringer Ingelheim Investigational Site

Ulm, , Germany

Countries

Germany

References

Dohner H, Muller-Tidow C, Lubbert M, Fiedler W, Kramer A, Westermann J, Bug G, Schlenk RF, Krug U, Goeldner RG, Hilbert J, Taube T, Ottmann OG. A phase I trial investigating the Aurora B kinase inhibitor BI 811283 in combination with cytarabine in patients with acute myeloid leukaemia. Br J Haematol. 2019 May;185(3):583-587. doi: 10.1111/bjh.15563. Epub 2018 Nov 19. No abstract available.

Reference Type: DERIVED

PMID: 30450591 (View on PubMed)

Other Identifiers

2007-005684-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1247.3

Identifier Type: -

Identifier Source: org_study_id