Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01662505
Recruitment Status : Completed
First Posted : August 10, 2012
Last Update Posted : July 31, 2015
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

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. Determination of the maximum tolerated dose based on the incidence of dose limiting toxicities [ Time Frame: up to 28 days ]

Secondary Outcome Measures :
  1. Complete remission (CR) [ Time Frame: up to 1 year ]
  2. Complete remission with incomplete blood count recovery (CRi) [ Time Frame: up to 1 year ]
  3. Partial remission (PR) [ Time Frame: up to 1 year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT01662505

1230.26.002 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1230.26.003 Boehringer Ingelheim Investigational Site
Isehara, Kanagawa, Japan
1230.26.005 Boehringer Ingelheim Investigational Site
Maebashi, Gunma,, Japan
1230.26.004 Boehringer Ingelheim Investigational Site
Nagasaki, Nagasaki, Japan
1230.26.001 Boehringer Ingelheim Investigational Site
Nagoya-shi, Aichi, Japan
1230.26.006 Boehringer Ingelheim Investigational Site
Yoshida-gun, Fukui, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim Identifier: NCT01662505     History of Changes
Other Study ID Numbers: 1230.26
First Posted: August 10, 2012    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type