Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia

PHASE2CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

November 27, 2008

Primary Completion Date

March 9, 2012

Study Completion Date

April 23, 2021

Conditions
Leukemia, Myeloid, Acute
Interventions
DRUG

Volasertib

Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).

DRUG

Cytarabine

Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.

Trial Locations (27)

1200

Brussels - UNIV Saint-Luc, Brussels

3000

UZ Leuven, Leuven

8000

AZ Sint-Jan Brugge, Bruges

8036

LKH-Univ. Hospital Graz, Graz

13353

Campus Virchow-Klinikum, Berlin, Berlin

14033

HOP Clémenceau, Hémato, Caen, Caen

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

24116

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel

25123

A.O. Spedali Civili di Brescia, Brescia

41100

Azienda Ospedaliera Policlinico di Modena, Modena

48149

Universitätsklinikum Münster, Münster

60590

Universitätsklinikum Frankfurt, Frankfurt am Main

69120

Universitätsklinikum Heidelberg, Heidelberg

69437

HOP Edouard Herriot, Lyon

75475

HOP Saint-Louis, Paris

76088

CTR Henri Becquerel, Rouen

79106

Universitätsklinikum Freiburg, Freiburg im Breisgau

87042

HOP Dupuytren 1, Limoges

89081

Universitätsklinikum Ulm, Ulm

95303

HOP, Centre Hospitalier René Dubos, Hémato, Paris, Cergy-Pontoise

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H3G 1A4

Montreal General Hospital - McGill University Health Centre, Montreal

J1H 5N4

CHUS Fleurimont, Sherbrooke

06189

CTR, fondation Paschetta, Hémato, Nice, Nice

N-5021

Haukeland Universitetssykehus, Bergen

N-0450

Oslo Universitetssykehus HF, Ullevål sykehus, Oslo

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT00804856 - Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia | Biotech Hunter | Biotech Hunter