Brief Summary

To investigate safety, tolerability, maximum tolerated dose of volasertib in Japanese patients with AML

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Aug 2012

Typical duration for phase_1

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

Study Start

First participant enrolled

August 1, 2012

Completed

7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed

3.2 years until next milestone

Results Posted

Study results publicly available

July 30, 2018

Completed

Last Updated

July 30, 2018

Status Verified

October 1, 2017

Enrollment Period

2.7 years

First QC Date

August 8, 2012

Results QC Date

October 23, 2017

Last Update Submit

October 23, 2017

Conditions

Leukemia, Myeloid, Acute

Outcome Measures

Primary Outcomes (2)

Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib
Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the number of participants with DLTs in cycle 1 is presented.
From first administration of trial drug up to 28 days
MTD of Volasertib
Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the MTD is presented.
From first administration of trial drug up to 28 days

Secondary Outcomes (4)

Best Response by Complete Remission (CR)
From first administration of trial drug up to 486 days
Best Response by CRi
From first administration of trial drug up to 486 days
Best Response by PR
From first administration of trial drug up to 486 days
Remission Duration
From first administration of trial drug up to 486 days

Study Arms (1)

Volasertib

EXPERIMENTAL

Patient to receive escalating dose of volasertib

Drug: Volasertib

Interventions

VolasertibDRUG

Patient to receive volasertib

Volasertib

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with diagnosis of AML (except for acute promyelocytic leukemia, APL) according to the World Health Organization definition and with one of the following features at screening
Relapsed or refractory AML
Untreated AML patients not considered to be suitable for standard induction therapy according to investigator's judgement
Male or female patients of age \>/= 18 years at the time of informed consent
Eastern Cooperative Oncology Group performance status score 0 - 2 at screening
Signed written informed consent consistent with Japanese Good Clinical Practice.

You may not qualify if:

Patients with APL
Patients in the third or later relapse
Prior stem cell transplantation
Treatment with systemic therapy for the primary disease (including an investigational drug) within 14 days before the first dose of volasertib with the exception of hydroxyurea, or lack of recovery from any acute toxicities or clinically significant adverse events pertinent to the prior systemic therapy
Treatment with gemtuzumab ozogamicin within 6 weeks before the first dose of volasertib
Concomitant medication/treatment with anti-leukemic chemotherapy (systemic or intrathecal), radiotherapy, immunotherapy, or any investigational agent while receiving study treatment
Other malignancy requiring treatment at the time of screening
Clinical central nervous system (CNS) symptoms deemed by the investigator to be related to leukemic CNS involvement or requiring treatment

Contact the study team to confirm eligibility.