Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Leukemia, Myeloid, Acute

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Volasertib

Patient to receive escalating dose of volasertib

Group Type EXPERIMENTAL

Volasertib

Intervention Type DRUG

Patient to receive volasertib

Interventions

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Volasertib

Patient to receive volasertib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Male or female patients of age \>/= 18 years at the time of informed consent
3. Eastern Cooperative Oncology Group performance status score 0 - 2 at screening
4. Signed written informed consent consistent with Japanese Good Clinical Practice.

Exclusion Criteria

1. Patients with APL
2. Patients in the third or later relapse
3. Prior stem cell transplantation
4. 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
5. Treatment with gemtuzumab ozogamicin within 6 weeks before the first dose of volasertib
6. Concomitant medication/treatment with anti-leukemic chemotherapy (systemic or intrathecal), radiotherapy, immunotherapy, or any investigational agent while receiving study treatment
7. Other malignancy requiring treatment at the time of screening
8. Clinical central nervous system (CNS) symptoms deemed by the investigator to be related to leukemic CNS involvement or requiring treatment

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No