Clinical Trials List
Protocol Number1230.43
NCT Number(ClinicalTrials.gov Identfier)NCT02721875
2016-07-01 - 2018-05-03
Phase I
Terminated2
ICD-9238.7
Neoplasm of uncertain behavior of other lymphatic and hematopoietic tissues
An open label, phase I trial of intravenous administration of volasertib as monotherapy or in combination with azacitidine in patients with myelodysplastic syndrome after hypomethylating agents treatment failure
-
Trial Applicant
Boehringer Ingelheim
-
Sponsor
Boehringer Ingelheim
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Li-Yuan Bai Division of Hematology & Oncology
- Ching-Chan Lin Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Principal Investigator
Co-Principal Investigator
- Su-Peng Yeh 未分科
Audit
None
Co-Principal Investigator
- 徐思淳 Division of Hematology & Oncology
- Huai-Hsuan Huang Division of Hematology & Oncology
- Chien-Chin Lin Division of Hematology & Oncology
- Wen-Chien Chou Division of Hematology & Oncology
- 劉家豪 Division of Hematology & Oncology
- Chieh-Lung Cheng Division of Hematology & Oncology
- Jih-Luh Tang Division of Hematology & Oncology
- 林建廷 Division of Hematology & Oncology
- CHENG-HONG TSAI Division of Hematology & Oncology
- - - Division of Hematology & Oncology
- 李啟誠 Division of Hematology & Oncology
- Tai-Chung Huang Division of Hematology & Oncology
- MING YAO Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
myelodysplastic syndrome, MDS
Objectives
The objectives of this trial are to evaluate the safety, tolerability, maximum
tolerated dose (MTD), pharmacokinetics and preliminary efficacy of volasertib
in two dosing schedules of intravenous volasertib as monotherapy or in
combination with azacitidine in patients with myelodysplastic syndrome (MDS)
after hypomethylating agents (HMA) treatment failure.
Test Drug
Volasertib
Active Ingredient
Volasertib
Dosage Form
Injection
Dosage
2.0
Endpoints
Primary Endpoints
Maximum tolerated dose (MTD)
Number of patients with Dose limiting toxicities (DLT) in the first treatment
cycle
Secondary Endpoints
Objective response defined as best overall response of CR ,PR and HI
according to the IWG 2006 criteria
Cmax and AUC0-tz of volasertib (for schedule A)
Cmax and AUC0- of volasertib (for schedule B)
Maximum tolerated dose (MTD)
Number of patients with Dose limiting toxicities (DLT) in the first treatment
cycle
Secondary Endpoints
Objective response defined as best overall response of CR ,PR and HI
according to the IWG 2006 criteria
Cmax and AUC0-tz of volasertib (for schedule A)
Cmax and AUC0- of volasertib (for schedule B)
Inclution Criteria
Inclusion criteria:
Patients 18 years and older with diagnosis of WHO classification-defined
primary or treatment-related myeloid neoplasms classified as follows:
o Refractory anaemia with excess blasts (RAEB)-1 (5%-9% marrow
blasts) or
o RAEB-2 (10%-19% marrow blasts or 5% - 19% peripheral blast) or
o CMML (5%-19% blasts) with white blood cell (WBC) count
<13000/mm3
or
o AML (20%-29% marrow blasts, i.e., RAEB-t according to FrenchAmerican-British [FAB] classification) with WBC count <10000/mm3
Patients classified as intermediate, high or very high-risk according to
Revised - International Prognostic Scoring System (IPSS-R) at the time of
enrolment
Patients who have received a maximum of 24 cycles of frontline HMA
treatment prior to enrolment.
Patients must have received a minimum prior dosing schedule of either:
o Azacitidine 75 mg/m2
x 5 days per cycle or 50 mg/m2
x 7 days per
cycle, or
o Decitabine 20 mg/m2
x 5 days per cycle, or
o SGI-110 60 mg/m2
x 5 days per cycle
Patients must meet either one of the following criteria:
o Progressive disease (PD, according to 2006 International Working
Group (IWG) criteria) at any time after initiation of the prior HMA
treatment, or
o Relapse after initial complete (CR) or partial remission (PR) or
haematological improvement (HI) (according to 2006 IWG criteria);
or
o Failure to achieve complete or partial remission or HI (according to
2006 IWG) with no evidence of progression (i.e., Stable Disease
[SD]) after at least six cycles of prior azacitidine treatment or at least
four cycles of other prior HMA treatment.
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
at screening
Signed written informed consent consistent with International Conference
of Harmonization Good Clinical Practice (ICH-GCP) and local legislation
Patients 18 years and older with diagnosis of WHO classification-defined
primary or treatment-related myeloid neoplasms classified as follows:
o Refractory anaemia with excess blasts (RAEB)-1 (5%-9% marrow
blasts) or
o RAEB-2 (10%-19% marrow blasts or 5% - 19% peripheral blast) or
o CMML (5%-19% blasts) with white blood cell (WBC) count
<13000/mm3
or
o AML (20%-29% marrow blasts, i.e., RAEB-t according to FrenchAmerican-British [FAB] classification) with WBC count <10000/mm3
Patients classified as intermediate, high or very high-risk according to
Revised - International Prognostic Scoring System (IPSS-R) at the time of
enrolment
Patients who have received a maximum of 24 cycles of frontline HMA
treatment prior to enrolment.
Patients must have received a minimum prior dosing schedule of either:
o Azacitidine 75 mg/m2
x 5 days per cycle or 50 mg/m2
x 7 days per
cycle, or
o Decitabine 20 mg/m2
x 5 days per cycle, or
o SGI-110 60 mg/m2
x 5 days per cycle
Patients must meet either one of the following criteria:
o Progressive disease (PD, according to 2006 International Working
Group (IWG) criteria) at any time after initiation of the prior HMA
treatment, or
o Relapse after initial complete (CR) or partial remission (PR) or
haematological improvement (HI) (according to 2006 IWG criteria);
or
o Failure to achieve complete or partial remission or HI (according to
2006 IWG) with no evidence of progression (i.e., Stable Disease
[SD]) after at least six cycles of prior azacitidine treatment or at least
four cycles of other prior HMA treatment.
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
at screening
Signed written informed consent consistent with International Conference
of Harmonization Good Clinical Practice (ICH-GCP) and local legislation
Exclusion Criteria
Exclusion criteria:
Prior systemic therapy (including investigational drugs) for MDS, CMML
or AML within 14 days before treatment with study medication.
Patients requiring intervention for white blood cell count control with
hydroxyurea, chemotherapy, or leukapheresis.
Prior exposure to more than one line of HMA based treatment.
Prior exposure to volasertib or other polo-kinase inhibitors
Patients who were unable to tolerate prior HMA treatment
Patients with history of hematopoietic stem cell transplant (HSCT)
Known hypersensitivity to the trial drugs or its excipients
Second malignancy currently requiring active therapy (except for
hormonal/anti-hormonal treatment, e.g., in prostate or breast cancer).
QTcF value >470 ms or QT prolongation deemed clinically relevant by the
investigator (e.g., congenital long QT syndrome).
Prior systemic therapy (including investigational drugs) for MDS, CMML
or AML within 14 days before treatment with study medication.
Patients requiring intervention for white blood cell count control with
hydroxyurea, chemotherapy, or leukapheresis.
Prior exposure to more than one line of HMA based treatment.
Prior exposure to volasertib or other polo-kinase inhibitors
Patients who were unable to tolerate prior HMA treatment
Patients with history of hematopoietic stem cell transplant (HSCT)
Known hypersensitivity to the trial drugs or its excipients
Second malignancy currently requiring active therapy (except for
hormonal/anti-hormonal treatment, e.g., in prostate or breast cancer).
QTcF value >470 ms or QT prolongation deemed clinically relevant by the
investigator (e.g., congenital long QT syndrome).
The Estimated Number of Participants
-
Taiwan
10 participants
-
Global
95 participants
