Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Volasertib

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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.

Exclusion criteria:

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

Sites / Locations

Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Volasertib

Arm Description

Patient to receive escalating dose of volasertib

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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]).

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%.

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.

Full Information

NCT ID

NCT01662505

First Posted

August 8, 2012

Last Updated

October 23, 2017

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01662505

Brief Title

Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Myeloid, Acute

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Volasertib

Arm Type

Experimental

Arm Description

Patient to receive escalating dose of volasertib

Intervention Type

Drug

Intervention Name(s)

Volasertib

Intervention Description

Patient to receive volasertib

Primary Outcome Measure Information:

Title

Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib

Description

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.

Time Frame

From first administration of trial drug up to 28 days

Title

MTD of Volasertib

Description

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.

Time Frame

From first administration of trial drug up to 28 days

Secondary Outcome Measure Information:

Title

Best Response by Complete Remission (CR)

Description

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.

Time Frame

From first administration of trial drug up to 486 days

Title

Best Response by CRi

Description

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]).

Time Frame

From first administration of trial drug up to 486 days

Title

Best Response by PR

Description

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%.

Time Frame

From first administration of trial drug up to 486 days

Title

Remission Duration

Description

The remission duration is the time from the date of achieving CR or CRi until relapse for patients with documented CR or CRi.

Time Frame

From first administration of trial drug up to 486 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion criteria: 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. Exclusion criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name