BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer
NCT ID: NCT01121406
Last Updated: 2015-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2010-04-30
2014-06-30
Brief Summary
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100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1.
Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727.
Others endpoints: biomarkers and pharmacogenetics analysis (optional)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BI 6727
Patients receive BI 6727 infusion every 3 weeks
BI 6727
Patients receive BI 6727 infusion every 3 weeks
Cytotoxic
At the investigator discretion, patient will receive one of the following cytotoxics: topotecan, paclitaxel, gemcitabine or liposomal doxorubicin
Paclitaxel
Patients receive paclitaxel in a 4 week schedule
Gemcitabine
Patients receive gemcitabine in a 3 week schedule
Topotecan
Patients receive topotecan in 3 or 4 week schedule
Pegylated liposomal doxorubicin (PLD)
Patients receive PLD in a 4 week schedule
Interventions
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Paclitaxel
Patients receive paclitaxel in a 4 week schedule
Gemcitabine
Patients receive gemcitabine in a 3 week schedule
Topotecan
Patients receive topotecan in 3 or 4 week schedule
Pegylated liposomal doxorubicin (PLD)
Patients receive PLD in a 4 week schedule
BI 6727
Patients receive BI 6727 infusion every 3 weeks
Eligibility Criteria
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Inclusion Criteria
2. Platinum resistant or platinum refractory disease.
3. Eastern Collaborative Oncology Group performance status \< = 2.
4. Life expectancy \> = 3 months.
5. At least one measurable lesion (Response Evaluation Criteria In Solid Tumours version 1.1).
6. Adequate hepatic, renal and bone marrow functions.
7. signed written informed consent prior to admission to the study.
Exclusion Criteria
2. Clinical evidence of active brain metastasis or leptomeningeal involvement.
3. Other malignancy currently requiring active therapy.
4. QTc prolongation according to Fridericia formula deemed clinically relevant by the investigator (e.g., congenital long QT syndrome, QTc according to Fridericia formula \> 470 ms).
5. Hypersensitivity to one of the trial drugs or the excipients.
6. Serious illness or concomitant non- oncological disease.
7. Systemic anticancer therapy within 4 weeks before the start of the study.
8. Evidence of ileus sor sub ileus.
18 Years
FEMALE
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1230.18.32003 Boehringer Ingelheim Investigational Site
Brussels, , Belgium
1230.18.32004 Boehringer Ingelheim Investigational Site
Edegem, , Belgium
1230.18.32002 Boehringer Ingelheim Investigational Site
Ghent, , Belgium
1230.18.32001 Boehringer Ingelheim Investigational Site
Leuven, , Belgium
1230.18.3321A Boehringer Ingelheim Investigational Site
Angers, , France
1230.18.3307A Boehringer Ingelheim Investigational Site
Bordeaux, , France
1230.18.3301A Boehringer Ingelheim Investigational Site
Caen, , France
1230.18.3322A Boehringer Ingelheim Investigational Site
Lille, , France
1230.18.3313A Boehringer Ingelheim Investigational Site
Lyon, , France
1230.18.3312A Boehringer Ingelheim Investigational Site
Nantes, , France
1230.18.3308A Boehringer Ingelheim Investigational Site
Nice, , France
1230.18.3302A Boehringer Ingelheim Investigational Site
Paris, , France
1230.18.3314A Boehringer Ingelheim Investigational Site
Paris, , France
1230.18.3309A Boehringer Ingelheim Investigational Site
Pierre-Bénite, , France
1230.18.3305A Boehringer Ingelheim Investigational Site
Reims, , France
1230.18.3320A Boehringer Ingelheim Investigational Site
Saint-Brieuc, , France
1230.18.3311A Boehringer Ingelheim Investigational Site
Strasbourg, , France
1230.18.3310A Boehringer Ingelheim Investigational Site
Toulouse, , France
1230.18.3315A Boehringer Ingelheim Investigational Site
Vandœuvre-lès-Nancy, , France
1230.18.42101 Boehringer Ingelheim Investigational Site
Bratislava, , Slovakia
1230.18.42103 Boehringer Ingelheim Investigational Site
Poprad, , Slovakia
1230.18.34006 Boehringer Ingelheim Investigational Site
Badalona, , Spain
1230.18.34001 Boehringer Ingelheim Investigational Site
Barcelona, , Spain
1230.18.34005 Boehringer Ingelheim Investigational Site
Barcelona, , Spain
1230.18.34007 Boehringer Ingelheim Investigational Site
Girona, , Spain
1230.18.34004 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat, , Spain
1230.18.34002 Boehringer Ingelheim Investigational Site
Madrid, , Spain
1230.18.34003 Boehringer Ingelheim Investigational Site
Madrid, , Spain
1230.18.46005 Boehringer Ingelheim Investigational Site
Linköping, , Sweden
1230.18.46001 Boehringer Ingelheim Investigational Site
Stockholm, , Sweden
1230.18.46003 Boehringer Ingelheim Investigational Site
Uppsala, , Sweden
Countries
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References
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Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
Pujade-Lauraine E, Selle F, Weber B, Ray-Coquard IL, Vergote I, Sufliarsky J, Del Campo JM, Lortholary A, Lesoin A, Follana P, Freyer G, Pardo B, Vidal L, Tholander B, Gladieff L, Sassi M, Garin-Chesa P, Nazabadioko S, Marzin K, Pilz K, Joly F. Volasertib Versus Chemotherapy in Platinum-Resistant or -Refractory Ovarian Cancer: A Randomized Phase II Groupe des Investigateurs Nationaux pour l'Etude des Cancers de l'Ovaire Study. J Clin Oncol. 2016 Mar 1;34(7):706-13. doi: 10.1200/JCO.2015.62.1474. Epub 2016 Jan 11.
Other Identifiers
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2009-015770-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1230.18
Identifier Type: -
Identifier Source: org_study_id
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