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Completed

NCT Number: NCT01662505

Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)

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

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Key information

Conditions

Leukemia, Myeloid, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Neoplasms Neoplasms by Histologic Type

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volasertib

Drug

Patient to receive volasertib

Primary outcomes

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

    Time frame: From first administration of trial drug up to 28 days

    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.

  2. MTD of Volasertib

    Time frame: From first administration of trial drug up to 28 days

    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 outcomes

  1. Best Response by Complete Remission (CR)

    Time frame: From first administration of trial drug up to 486 days

    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.

  2. Best Response by CRi

    Time frame: From first administration of trial drug up to 486 days

    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]).

  3. Best Response by PR

    Time frame: From first administration of trial drug up to 486 days

    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%.

  4. Remission Duration

    Time frame: From first administration of trial drug up to 486 days

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 10, 2012
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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