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A Study of Volasertib Plus Induction Chemotherapy for Acute Myeloid Leukemia

NCT02527174 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-04-05

No results posted yet for this study

Summary

This is a Phase I clinical trial to determine the maximum tolerated dose (MTD) of the polo-like kinase-1 inhibitor volasertib which can be safely combined with idarubicin plus cytarabine induction chemotherapy for previously untreated patients with acute myeloid leukemia. (AML).

Conditions

  • Leukemia, Myeloid, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute

Interventions

DRUG

Volasertib

Addition of single dose of volasertib intravenously (IV) on Day 4 of treatment protocol.

DRUG

Idarubicin

Given IV daily on Days 1-3 of treatment protocol.

DRUG

Cytarabine

Given IV daily as 24-hour continuous infusion on Day 1-7 of treatment protocol.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Joseph Brandwein, MD · University of Alberta

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-05-31
Completion
2018-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT02527174 on ClinicalTrials.gov