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Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)

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ClinicalTrials.gov Identifier: NCT01662505
Recruitment Status : Completed
First Posted : August 10, 2012
Results First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: Volasertib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


Arm Intervention/treatment
Experimental: Volasertib
Patient to receive escalating dose of volasertib
Drug: Volasertib
Patient to receive volasertib




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662505


Locations
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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, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01662505     History of Changes
Other Study ID Numbers: 1230.26
First Posted: August 10, 2012    Key Record Dates
Results First Posted: July 30, 2018
Last Update Posted: July 30, 2018
Last Verified: October 2017
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms