Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)

Leukemia, Myeloid, Acute Clinical Trial

Official title:

An Open Label, Phase I Trial of Intravenous Once Every 2 Weeks Administration of BI 6727 (Volasertib) in Japanese Patients With Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662505
• Other study ID #: 1230.26
• Status: Completed
• Phase: Phase 1
• Start date: August 2012
• Est. completion date: May 2015

Study information

• Verified date: October 2017
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Volasertib
Patient to receive volasertib

Locations

Country	Name	City	State
Japan	Boehringer Ingelheim Investigational Site	Chuo-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Isehara, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Maebashi, Gunma,
Japan	Boehringer Ingelheim Investigational Site	Nagasaki, Nagasaki
Japan	Boehringer Ingelheim Investigational Site	Nagoya-shi, Aichi
Japan	Boehringer Ingelheim Investigational Site	Yoshida-gun, Fukui

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Best Response by Complete Remission (CR)	The secondary outcome best response will be presented by the CR, CR with incomplete blood count recovery (CRi) and partial remission (PR).; In this outcome measure the CR will be presented.; The criteria for the CR are: Bone marrow blasts less than 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) >1.0 × 10^9/Litre (L) (1000/microlitre (µL)); platelet count >100 × 10^9/L (100 000/µL); independence of red cell transfusions.	From first administration of trial drug up to 486 days
Secondary	Best Response by CRi	The secondary outcome best response will be presented by the CR, CRi and PR. In this outcome measure the CRi will be presented.; The criteria for the CRi are: All CR criteria are met except for residual neutropenia (<1.0 × 10^9/L [1000/µL]) or thrombocytopenia (<100 × 10^9/L [100 000/µL]).	From first administration of trial drug up to 486 days
Secondary	Best Response by PR	The secondary outcome best response will be presented by the CR, CRi and PR. In this outcome measure the PR is presented.; The criteria for the PR are: All haematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.	From first administration of trial drug up to 486 days
Secondary	Remission Duration	The remission duration is the time from the date of achieving CR or CRi until relapse for patients with documented CR or CRi.	From first administration of trial drug up to 486 days

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