Spots Global Cancer Trial Database for Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)
Official Title: An Open Label, Phase I, Dose Escalation Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Volasertib in Combination With Decitabine in Patients >= 65 Years With Acute Myeloid Leukemia
Study ID: NCT02003573
Conditions
Study Description
Brief Summary: Dose Escalation (MTD Finding) Phase: To investigate the maximum tolerated dose (MTD), safety and pharmacokinetics of different volasertib administration schedules in combination with decitabine in previously untreated AML patients \>= 65 years of age who are considered ineligible for standard intensive therapy, or patients with relapsed or refractory AML regardless of prior treatment status. MTD Extension Phase: To collect additional data on safety, efficacy and pharmacokinetics of volasertib in combination with decitabine in previously untreated patients with AML \>= 65 years of age and considered ineligible for standard intensive therapy.
Detailed Description:
Keywords
Eligibility
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Yale Cancer Center, New Haven, Connecticut, United States
Washington School of Medicine, Saint Louis, Missouri, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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