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Spots Global Cancer Trial Database for A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)

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Trial Identification

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

Interventions

Decitabine
BI 836858

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Boehringer Ingelheim

Affiliation: Boehringer Ingelheim

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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