Clinical trial · Interventional
Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)
An Open Label, Phase I Trial of Intravenous Once Every 2 Weeks Administration of BI 6727 (Volasertib) in Japanese Patients With Acute Myeloid Leukemia
NCT01662505CI-TRIAL-00034043completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate safety, tolerability, maximum tolerated dose of volasertib in Japanese patients with AML
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Volasertib | Drug | Volasertib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Volasertib
- description
- Patient to receive escalating dose of volasertib
- interventionNames
- Drug: Volasertib
Primary outcomes (2)
- 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
- description
- 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.
- measure
- MTD of Volasertib
- timeFrame
- From first administration of trial drug up to 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.