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Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)

NCT02003573 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-01-31

Study results available
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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.

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DRUG

decitabine iv

decitabine iv fixed dose

DRUG

volasertib iv infusion

volasertib iv infusion (Body Surface Area (BSA) based dosing)

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-29
Primary Completion
2015-01-06
Completion
2016-05-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02003573 on ClinicalTrials.gov