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Brief Title: A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
Official Title: An Open-label, Phase I/II Trial to Determine the Maximum Tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 836858 in Combination With Decitabine in Patients With Acute Myeloid Leukemia
Study ID: NCT02632721
Brief Summary: Phase I Dose Escalation: Primary objective is to determine the Maximum Tolerated Dose (MTD) and the recommended dose for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine. Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Cancer Center, Jacksonville, Florida, United States
Northwestern University, Chicago, Illinois, United States
Northwell Health, Lake Success, New York, United States
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Universitätsklinikum Augsburg, Augsburg, , Germany
Vivantes Netzwerk für Gesundheit GmbH, Berlin, , Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Universitätsklinikum Jena, Jena, , Germany
Universitätsklinikum Münster, Münster, , Germany
A.O. Spedali Civili di Brescia, Brescia, , Italy
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital Politècnic La Fe, Valencia, , Spain
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR