NCT02905994

Volasertib Combined With Induction Chemotherapy in Acute Myeloid Leukemia

A Phase I Trial of Volasertib (BI 6727), an Intravenous Polo-Like Kinase Inhibitor, in Combination With "7+3" Induction Chemotherapy for Patients With Acute Myeloid Leukemia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study intervention involved in this study is the addition of a dose of volasertib as a part of the initial chemotherapy regimen for AML. The trial will involve a combination of the following drugs: * Volasertib (the study drug) * Idarubicin * Cytarabine

Detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. As part of this research study, the participant will receive Volasertib in combination with two other chemotherapy drugs, Idarubicin and Cytarabine. The FDA (the U.S. Food and Drug Administration) has not approved volasertib as a treatment for any disease. Idarubicin and Cytarabine are chemotherapy agents that are commonly used to treat individuals diagnosed with AML. Volasertib inhibits proteins called "polo-like kinases," which are necessary for cell division. Volasertib binds to these proteins and this inhibits the growth of cancer cells. Volasertib has been used in laboratory studies and those studies suggest that volasertib may slow down the growth of Cancer. In a previous clinical trial in patients with the participant type of leukemia where Volasertib was given along with low doses of Cytarabine, this drug was found to have some clinical activity against AML. In this study, researchers would like to combine Volasertib with standard chemotherapy (Cytarabine and Idarubicin) in order to see if it can be given safely with chemotherapy in individuals with AML. The primary purpose of this research study is to determine the highest dose that Volasertib can be given with Idarubicin and Cytarabine without severe or unmanageable side effects. The dose identified in this study will be used in future research studies.

Conditions

• AML

Interventions

Type	Name	Description
DRUG	Volasertib	Polo-Like Kinase Inhibitor
DRUG	Cytarabine	Standard chemotherapy at dosage and schedule for 7+3 induction
DRUG	Idarubicin	Standard chemotherapy at dosage and schedule for 7+3 induction
PROCEDURE	Bone Marrow Biopsy	Bone marrow biopsy assessments scheduled during induction to assess response

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-09-19
• Last updated: 2018-05-04

Locations

2 sites across 1 country: United States