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

NCT00632749 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2015-09-14

Study results available
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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

Interventions

DRUG

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

DRUG

Cytarabine

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

DRUG

BI 811283 (d1)

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

DRUG

Cytarabine

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00632749 on ClinicalTrials.gov