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An Open Label, Phase I Trial of Intravenous Once Every 2 Weeks Administration of Volasertib in Japanese Patients With Acute Myeloid Leukaemia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Myeloid, Acute

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Trial Information

An Open Label, Phase I Trial of Intravenous Once Every 2 Weeks Administration of Volasertib in Japanese Patients With Acute Myeloid Leukaemia

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of the maximum tolerated dose based on the incidence of dose limiting toxicities

Outcome Time Frame:

up to 28 days

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

1230.26

NCT ID:

NCT01662505

Start Date:

August 2012

Completion Date:

April 2014

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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