At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 68 enrolled
Drug / intervention
BI 811283 (d 1 and 15) +3 moredrug
Likely dose
Cytarabine 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Safety, Efficacy and Pharmacokinetics of BI 811283 in Combination With Cytarabine in Patients With Previously Untreated Acute Myeloid Leukaemia Ineligible for Intensive Treatment
In Brief
A Phase 2 clinical trial evaluating BI 811283 (d 1 and 15), Cytarabine, and 1 other intervention for Leukemia, Myeloid, Acute. Completed, enrolled 68 participants across 7 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloid, Acute
CountriesGermany
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2008
Enrollment StartMay 2008
Primary CompletionMar 2014
TodayJul 2026
First PostedMar 11, 2008
Enrollment StartMay 1, 2008
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 18.3 years ago
Interventions
BI 811283 (d 1 and 15)drug
BI 811283 (24 hours i.v.c.i.) on day 1 and 15 of a 4-week treatment cycle
Cytarabinedrug
Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle
BI 811283 (d1)drug
BI 811283 (24 hours i.v.c.i.) on day 1 of a 4-week treatment cycle
Cytarabinedrug
Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle