Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)

Phase 1

Completed

• Conditions: Leukemia, Myeloid, Acute
• Interventions: Drug: Volasertib

• Registration Number: NCT01662505
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-10
• Results First Submitted: 2017-10-23
• Results First Submitted QC: 2017-10-23
• Last Update Submitted: 2017-10-23
• Results First Posted: 2018-07-30
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volasertib	Volasertib	Patient to receive escalating dose of volasertib

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib	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.
MTD of Volasertib	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

Name	Time	Method
Best Response by Complete Remission (CR)	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.
Best Response by CRi	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 \[100 000/μL\]).
Best Response by PR	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%.
Remission Duration	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.

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇯🇵 Yoshida-gun, Fukui, Japan