search
Back to results

Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)

Primary Purpose

Leukemia, Myeloid, Acute

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Volasertib
Cytarabine
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Age >= 65years.
  2. Cytologically/histologically confirmed acute myeloid leukaemia (AML) according to WHO classification; (except for acute promyelocytic leukaemia (APL).
  3. Previously untreated AML (except for hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Previous therapy for Myelodysplastic Syndrome (MDS) is allowed.
  4. Investigator considers patient ineligible for intensive remission induction therapy based on documented medical reasons (e.g. disease characteristics like AML genetics, type of AML (de novo or secondary), and patient characteristics like performance score, concomitant diagnoses, organ dysfunctions).
  5. Patient is eligible for Low-Dose Cytarabine (LDAC) treatment.
  6. Eastern co-operative oncology group (ECOG) performance score <= 2 at screening.
  7. Signed and dated written informed consent by start date of Screening visit in accordance with Good Clinical Practice (GCP) and local legislation.

Exclusion criteria:

  1. Prior or concomitant chemotherapy for AML (with the exception of hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Please note that any prior therapy for MDS is allowed.
  2. Treatment with any investigational drug within 2 weeks before first administration of present trial drug.
  3. Acute promyelocytic leukaemia (French-American-British (FAB) classification subtype M3).
  4. Current clinical central nervous system (CNS) symptoms deemed by the investigator to be related to leukaemic CNS involvement (no lumbar puncture required, clinical assessment per investigator´s judgement is sufficient).
  5. Hypersensitivity to one of the trial drugs or the excipients.
  6. Severe illness or organ dysfunction involving the heart, kidney, liver or other organ system (e.g. active infection, clinically relevant impairment of cardiac function, severe heart failure/cardiac insufficiency, unstable angina pectoris or history of recent myocardial infarction), which in the opinion of the investigator precludes treatment with LDAC.
  7. Corrected QT interval according to Fridericia (QTcF) prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 Electrocardiogram (ECGs) taken at screening.
  8. Total bilirubin > 3 x upper limit of normal (ULN).
  9. Creatinine clearance (CLcr) < 30 ml/min (estimated creatinine clearance by the Cockcroft-Gault (C-G) equation) .
  10. Active hepatitis B or hepatitis C, or laboratory evidence for a chronic infection.
  11. HIV infection.
  12. Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment e.g. in prostate or breast cancer).
  13. Any significant concurrent psychiatric disorder or social situation that according to the investigator´s judgement would compromise patient´s safety or compliance, interfere with consent, study participation, or interpretation of study results.
  14. Known or suspected active alcohol or drug abuse.
  15. Patient unable to comply with the protocol, in the opinion of the investigator.
  16. Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial and for a minimum of 6 months after study treatment.

Sites / Locations

  • University of California
  • St. Luke's Hospital Association of Duluth, Inc.
  • Henry-Joyce Cancer Clinic
  • The University of Texas MD Anderson Cancer Center
  • Fundacion COIR
  • Hospital Central de Salud Zenón Santillan
  • LKH-Univ. Hospital Graz
  • LKH Leoben
  • Hospital Hietzing
  • AZ Sint-Jan Brugge
  • Brussels - UNIV Saint-Luc
  • Haine-St-Paul - HOSP Jolimont
  • Jessa Ziekenhuis - Campus Virga Jesse
  • UZ Leuven
  • Centre Hospitalier Universitaire de Liège
  • Roeselare - HOSP AZ Delta
  • Yvoir - UNIV UCL de Mont-Godinne
  • Hospital Doutor Amaral Carvalho
  • Hospital Mãe de Deus
  • H.C.da Fac. de Medicina de Ribeirao Preto
  • University of Alberta Hospital (University of Alberta)
  • Vancouver General Hospital
  • Maisonneuve-Rosemont Hospital
  • Princess Margaret Cancer Centre
  • Montreal General Hospital - McGill University Health Centre
  • Hospital Hradec Kralove
  • University Hospital Plzen, Plzen-Lochotin
  • Univ. Hospital Kralovske Vinohrady
  • Meilahden sairaala
  • TYKS, Sisätautien klinikka
  • HOP Amiens-Picardie Sud
  • HOP Côte de Nacre
  • HOP Michallon
  • HOP André Mignot
  • HOP Dupuytren 1
  • INS Paoli-Calmettes
  • HOP Nantes, Hémato, Nantes
  • HOP Saint-Antoine
  • HOP Haut-Lévêque
  • HOP Lyon Sud
  • HOP Pontchaillou
  • INS Universitaire du Cancer
  • Universitätsklinikum Augsburg
  • Med. Klinik m.S. Hämatologie und Onkologie
  • Städtisches Klinikum Braunschweig gGmbH
  • Universitätsklinikum Erlangen
  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
  • Universitätsklinikum Frankfurt
  • Universitätsmedizin Göttingen, Georg-August-Universität
  • Martin-Luther-Universität Halle-Wittenberg
  • Universitätsklinikum Hamburg-Eppendorf
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Universitätsklinikum Gießen und Marburg GmbH
  • Klinikum rechts der Isar der Technischen Universität München
  • Universitätsklinikum Münster
  • Universitätsklinikum Regensburg
  • Robert-Bosch-Krankenhaus GmbH
  • Universitätsklinikum Ulm
  • Schwarzwald-Baar Klinikum
  • General Hospital of Athens "G. Gennimatas"
  • General Hospital of Athens "Laiko"
  • Univ. Gen. Hosp. of Ioannina
  • University of Patras Medical School
  • General Hospital of Thessaloniki "G. Papanikolaou"
  • Semmelweis University
  • Petz Aldar Hospital, 2nd Dept. of Internal Med., Haematology
  • Univ. of Szeged, 2nd Dept. of Internal Med., Haematology
  • St. John Medical College and hospital
  • Tata Memorial Hospital
  • A.O. Spedali Civili di Brescia
  • ASST Grande Ospedale Metropolitano Niguarda
  • AO Città della Salute e della
  • National Hospital Organization Nagoya Medical Center
  • Japanese Red Cross Nagoya Daini Hospital
  • Akita University Hospital
  • University of Fukui Hospital
  • Kyushu University Hospital
  • Kobe University Hospital
  • Tokai University Hospital
  • Yokohama City University Medical Center
  • Tohoku University Hospital
  • Nagasaki University Hospital
  • Kurashiki Central Hospital
  • Okayama University Hospital
  • Osaka City University Hospital
  • National Cancer Center Hospital
  • NTT Medical Center Tokyo
  • Chonnam National University Hwasun Hospital
  • The Catholic University of Korea, Seoul St.Mary's Hospital
  • Seoul National University Hospital
  • Severance Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Amsterdam UMC Locatie VUMC
  • Haukeland Universitetssykehus
  • Sykehuset Østfold Kalnes
  • Reg. Specialist Hospital of M. Kopernik, Dept. Haematology
  • City Hospital Torun, Department of Hematology
  • CHULN, EPE - Hospital de Santa Maria
  • Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António
  • IPO Porto Francisco Gentil, EPE
  • Centro Hospitalar Universitário São João,EPE
  • Regional Clinical Hospital 'The Badge of Honor Order'
  • FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
  • Nizhniy Novgorod Reg. Clinical Hospital, Dept. Haematology
  • Leningrad Reg. Clin. Hosp., Oncohematology Department No. 2
  • Netcare Pretoria East Hospital
  • Hospital Germans Trias i Pujol
  • Hospital Santa Creu i Sant Pau
  • Hospital Vall d'Hebron
  • Hospital Clínic de Barcelona
  • Hospital Universitario 12 de Octubre
  • Hospital La Paz
  • Hospital Universitario de Salamanca
  • Hospital Politècnic La Fe
  • Chang-Hua Christian Hospital
  • National Taiwan University Hospital
  • Mackay Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Volasertib and Cytarabine

Placebo and Cytarabine

Arm Description

Outcomes

Primary Outcome Measures

Objective Response (OR)
OR is the number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi), where OR was based on the best response attained during the treatment period.

Secondary Outcome Measures

Overall Survival (OS)
OS is the key secondary endpoint and was measured from the date of randomization until death from any cause. Patients who were lost to follow-up were censored on the last date they were known to be alive.
Event-free Survival (EFS)
EFS was measured from the date of randomisation to the date of progression or relapse, or death from any cause, whichever occurred first.
Relapse-free Survival (RFS)
RFS was defined only for patients who achieved best overall response of CR or CRi; it was measured from the date of achievement of a remission until the date of relapse or death from any cause. Patients not known to have relapsed or died at last follow-up were censored on the date they were last examined.

Full Information

First Posted
November 2, 2012
Last Updated
February 6, 2023
Sponsor
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT01721876
Brief Title
Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)
Official Title
A Phase III Randomised, Double-blind, Controlled, Parallel Group Study of Intravenous Volasertib in Combination With Subcutaneous Low-dose Cytarabine vs. Placebo + Low-dose Cytarabine in Patients >=65 Years With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 29, 2013 (Actual)
Primary Completion Date
August 12, 2014 (Actual)
Study Completion Date
May 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients >= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
666 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Volasertib and Cytarabine
Arm Type
Experimental
Arm Title
Placebo and Cytarabine
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching Volasertib
Intervention Type
Drug
Intervention Name(s)
Volasertib
Intervention Description
Volasertib
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
Cytarabine
Primary Outcome Measure Information:
Title
Objective Response (OR)
Description
OR is the number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi), where OR was based on the best response attained during the treatment period.
Time Frame
Response assessment was performed at the end of every 2nd cycle, (i.e. at the end of Cycle 2, 4, 6, 8, etc., and at end of treatment), i.e. up to 52 months.
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is the key secondary endpoint and was measured from the date of randomization until death from any cause. Patients who were lost to follow-up were censored on the last date they were known to be alive.
Time Frame
From randomization until death due to any cause, up to 1557 days.
Title
Event-free Survival (EFS)
Description
EFS was measured from the date of randomisation to the date of progression or relapse, or death from any cause, whichever occurred first.
Time Frame
From randomization until disease progression or relapse or death from any cause, up to 1557 days.
Title
Relapse-free Survival (RFS)
Description
RFS was defined only for patients who achieved best overall response of CR or CRi; it was measured from the date of achievement of a remission until the date of relapse or death from any cause. Patients not known to have relapsed or died at last follow-up were censored on the date they were last examined.
Time Frame
From randomization until disease progression or relapse or death from any cause, up to 1557 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age >= 65years. Cytologically/histologically confirmed acute myeloid leukaemia (AML) according to WHO classification; (except for acute promyelocytic leukaemia (APL). Previously untreated AML (except for hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Previous therapy for Myelodysplastic Syndrome (MDS) is allowed. Investigator considers patient ineligible for intensive remission induction therapy based on documented medical reasons (e.g. disease characteristics like AML genetics, type of AML (de novo or secondary), and patient characteristics like performance score, concomitant diagnoses, organ dysfunctions). Patient is eligible for Low-Dose Cytarabine (LDAC) treatment. Eastern co-operative oncology group (ECOG) performance score <= 2 at screening. Signed and dated written informed consent by start date of Screening visit in accordance with Good Clinical Practice (GCP) and local legislation. Exclusion criteria: Prior or concomitant chemotherapy for AML (with the exception of hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Please note that any prior therapy for MDS is allowed. Treatment with any investigational drug within 2 weeks before first administration of present trial drug. Acute promyelocytic leukaemia (French-American-British (FAB) classification subtype M3). Current clinical central nervous system (CNS) symptoms deemed by the investigator to be related to leukaemic CNS involvement (no lumbar puncture required, clinical assessment per investigator´s judgement is sufficient). Hypersensitivity to one of the trial drugs or the excipients. Severe illness or organ dysfunction involving the heart, kidney, liver or other organ system (e.g. active infection, clinically relevant impairment of cardiac function, severe heart failure/cardiac insufficiency, unstable angina pectoris or history of recent myocardial infarction), which in the opinion of the investigator precludes treatment with LDAC. Corrected QT interval according to Fridericia (QTcF) prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 Electrocardiogram (ECGs) taken at screening. Total bilirubin > 3 x upper limit of normal (ULN). Creatinine clearance (CLcr) < 30 ml/min (estimated creatinine clearance by the Cockcroft-Gault (C-G) equation) . Active hepatitis B or hepatitis C, or laboratory evidence for a chronic infection. HIV infection. Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment e.g. in prostate or breast cancer). Any significant concurrent psychiatric disorder or social situation that according to the investigator´s judgement would compromise patient´s safety or compliance, interfere with consent, study participation, or interpretation of study results. Known or suspected active alcohol or drug abuse. Patient unable to comply with the protocol, in the opinion of the investigator. Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial and for a minimum of 6 months after study treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1678
Country
United States
Facility Name
St. Luke's Hospital Association of Duluth, Inc.
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Henry-Joyce Cancer Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fundacion COIR
City
Mendoza
ZIP/Postal Code
M5500AYB
Country
Argentina
Facility Name
Hospital Central de Salud Zenón Santillan
City
San Miguel de Tucumán
ZIP/Postal Code
T4000HXU
Country
Argentina
Facility Name
LKH-Univ. Hospital Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
LKH Leoben
City
Leoben
ZIP/Postal Code
8700
Country
Austria
Facility Name
Hospital Hietzing
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
AZ Sint-Jan Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Brussels - UNIV Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Haine-St-Paul - HOSP Jolimont
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Jessa Ziekenhuis - Campus Virga Jesse
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Roeselare - HOSP AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Yvoir - UNIV UCL de Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Hospital Doutor Amaral Carvalho
City
Jau
ZIP/Postal Code
17210-080
Country
Brazil
Facility Name
Hospital Mãe de Deus
City
Porto Alegre
ZIP/Postal Code
90470-340
Country
Brazil
Facility Name
H.C.da Fac. de Medicina de Ribeirao Preto
City
Ribeirao Preto
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
University of Alberta Hospital (University of Alberta)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Migration Data
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Montreal General Hospital - McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
University Hospital Plzen, Plzen-Lochotin
City
Plzen - Lochotin
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Univ. Hospital Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Meilahden sairaala
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
TYKS, Sisätautien klinikka
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
HOP Amiens-Picardie Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
HOP Côte de Nacre
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
HOP Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
HOP André Mignot
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
HOP Dupuytren 1
City
Limoges Cedex 1
ZIP/Postal Code
87042
Country
France
Facility Name
INS Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
HOP Nantes, Hémato, Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
HOP Saint-Antoine
City
Paris Cedex 12
ZIP/Postal Code
75012
Country
France
Facility Name
HOP Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
HOP Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
HOP Pontchaillou
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
INS Universitaire du Cancer
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Universitätsklinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Med. Klinik m.S. Hämatologie und Onkologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Städtisches Klinikum Braunschweig gGmbH
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsmedizin Göttingen, Georg-August-Universität
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Martin-Luther-Universität Halle-Wittenberg
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität München
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus GmbH
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Schwarzwald-Baar Klinikum
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
General Hospital of Athens "G. Gennimatas"
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
General Hospital of Athens "Laiko"
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
Univ. Gen. Hosp. of Ioannina
City
Ioannina
ZIP/Postal Code
45 500
Country
Greece
Facility Name
University of Patras Medical School
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
General Hospital of Thessaloniki "G. Papanikolaou"
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Petz Aldar Hospital, 2nd Dept. of Internal Med., Haematology
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Univ. of Szeged, 2nd Dept. of Internal Med., Haematology
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
St. John Medical College and hospital
City
Bangalore
ZIP/Postal Code
560034
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
A.O. Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
AO Città della Salute e della
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
National Hospital Organization Nagoya Medical Center
City
Aichi, Nagoya
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Japanese Red Cross Nagoya Daini Hospital
City
Aichi, Nagoya
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Akita University Hospital
City
Akita, Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
University of Fukui Hospital
City
Fukui, Yoshida-gun
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka, Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kobe University Hospital
City
Hyogo, Kobe
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Tokai University Hospital
City
Kanagawa, Isehara
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Kanagawa, Yokohama
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi, Sendai
ZIP/Postal Code
980-8547
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki, Nagasaki
ZIP/Postal Code
852-8523
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Okayama, Kurashiki
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama, Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka, Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo, Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Tokyo, Sinagawa-ku
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St.Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Amsterdam UMC Locatie VUMC
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Haukeland Universitetssykehus
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
Facility Name
Sykehuset Østfold Kalnes
City
Grålum
ZIP/Postal Code
N-1714
Country
Norway
Facility Name
Reg. Specialist Hospital of M. Kopernik, Dept. Haematology
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
City Hospital Torun, Department of Hematology
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
CHULN, EPE - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
IPO Porto Francisco Gentil, EPE
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Centro Hospitalar Universitário São João,EPE
City
Porto
ZIP/Postal Code
4202-451
Country
Portugal
Facility Name
Regional Clinical Hospital 'The Badge of Honor Order'
City
Irkutsk
ZIP/Postal Code
664079
Country
Russian Federation
Facility Name
FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Nizhniy Novgorod Reg. Clinical Hospital, Dept. Haematology
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Leningrad Reg. Clin. Hosp., Oncohematology Department No. 2
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Netcare Pretoria East Hospital
City
Moreleta Park, Pretoria
ZIP/Postal Code
0044
Country
South Africa
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Politècnic La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Chang-Hua Christian Hospital
City
ChangHua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Citations:
PubMed Identifier
34646387
Citation
Hagege A, Ambrosetti D, Boyer J, Bozec A, Doyen J, Chamorey E, He X, Bourget I, Rousset J, Saada E, Rastoin O, Parola J, Luciano F, Cao Y, Pages G, Dufies M. The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy. Theranostics. 2021 Sep 21;11(19):9571-9586. doi: 10.7150/thno.61711. eCollection 2021.
Results Reference
derived
Links:
URL
http://www.mystudywindow.com/
Description
Related Info

Learn more about this trial

Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)

We'll reach out to this number within 24 hrs