Clinical trial NCT01662505: Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia, Myeloid, Acute
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-08-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib
timeFrame: From first administration of trial drug up to 28 days
measure: MTD of Volasertib
timeFrame: From first administration of trial drug up to 28 days
Secondary outcomes:
measure: Best Response by Complete Remission (CR)
timeFrame: From first administration of trial drug up to 486 days
measure: Best Response by CRi
timeFrame: From first administration of trial drug up to 486 days
measure: Best Response by PR
timeFrame: From first administration of trial drug up to 486 days
measure: Remission Duration
timeFrame: From first administration of trial drug up to 486 days
Other outcomes:
Locations:
city: Chuo-ku, Tokyo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Isehara, Kanagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Maebashi, Gunma,
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nagasaki, Nagasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nagoya-shi, Aichi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yoshida-gun, Fukui
country: Japan
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: