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Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01662505
First received: August 8, 2012
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Leukemia, Myeloid, Acute
Drug: Volasertib
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Determination of the maximum tolerated dose based on the incidence of dose limiting toxicities [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete remission (CR) [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Complete remission with incomplete blood count recovery (CRi) [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Partial remission (PR) [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: February 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Volasertib
Patient to receive escalating dose of volasertib
Drug: Volasertib
Patient to receive volasertib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662505

Locations
Japan
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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01662505     History of Changes
Other Study ID Numbers: 1230.26
Study First Received: August 8, 2012
Last Updated: November 5, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on November 25, 2014