NCT00632749

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-05-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2008-03-11
• Last updated: 2015-09-14
• Results posted: 2015-05-25

Locations

7 sites across 1 country: Germany