Spots Global Cancer Trial Database for Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia
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Trial Identification
Brief Title: Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia
Official Title: An Open Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous BI 6727 as Monotherapy or in Combination With Subcutaneous Cytarabine in Patients With Acute Myeloid Leukaemia
Study ID: NCT00804856
Conditions
Study Description
Brief Summary: The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I part of the trial, BI 6727 will be investigated as monotherapy and in combination with low dose cytarabine (LD-Ara-C) in patients with relapsed/refractory AML that are not eligible for intensive treatment. The dose of BI 6727 will be escalated to determine the maximum tolerated dose (MTD) of BI 6727 monotherapy and BI 6727 in combination with LD-Ara-C in AML patients. In the phase IIa part, the combination of BI 6727 at MTD with LD-Ara-C and LD-Ara-C monotherapy will be investigated to explore the efficacy of the combination schedule in comparison to LD-Ara-C monotherapy in previously untreated AML patients that are not eligible for intensive treatment.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
LKH-Univ. Hospital Graz, Graz, , Austria
AZ Sint-Jan Brugge, Brugge, , Belgium
Brussels - UNIV Saint-Luc, Bruxelles, , Belgium
UZ Leuven, Leuven, , Belgium
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Montreal General Hospital - McGill University Health Centre, Montreal, Quebec, Canada
CHUS Fleurimont, Sherbrooke, Quebec, Canada
HOP Clémenceau, Hémato, Caen, Caen, , France
HOP, Centre Hospitalier René Dubos, Hémato, Paris, Cergy Pontoise Cedex, , France
HOP Dupuytren 1, Limoges, , France
HOP Edouard Herriot, Lyon Cedex 03, , France
CTR, fondation Paschetta, Hémato, Nice, Nice Cedex 2, , France
HOP Saint-Louis, Paris cedex 10, , France
CTR Henri Becquerel, Rouen Cedex, , France
Campus Virchow-Klinikum, Berlin, Berlin, , Germany
Universitätsklinikum Frankfurt, Frankfurt/Main, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, , Germany
Universitätsklinikum Münster, Münster, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
A.O. Spedali Civili di Brescia, Brescia, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Azienda Ospedaliera Policlinico di Modena, Modena, , Italy
Haukeland Universitetssykehus, Bergen, , Norway
Oslo Universitetssykehus HF, Ullevål sykehus, Oslo, , Norway
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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