BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer

NCT01121406 | Completed Phase 2 Results

• 2 other identifiers: 1230.182009-015770-35
• Study Type: interventional
• Target: 110
• Locations: 5 countries
• Sites: 31

Brief Summary

This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer. 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)

Conditions

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1

  DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).

  Week 24

Secondary Outcomes (26)

• Progression Free Survival (PFS)

  From randomization until disease progression, death or study discontinuation; Up to 213 weeks

• Overall Survival (OS)

  From randomization until death or study discontinuation; Up to 213 weeks

• Best Overall Response

  time from the date of randomisation until study completion/discontinuation; Up to 213 weeks

• Biological Tumour Response Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria

  At screening and every 6 weeks thereafter (Up to 213 weeks)

• Biological Progression-free Survival Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria

  At screening and every 6 weeks thereafter (Up to 213 weeks )

Study Arms (2)

BI 6727

EXPERIMENTAL

Patients receive BI 6727 infusion every 3 weeks

Drug: BI 6727

Cytotoxic

ACTIVE COMPARATOR

At the investigator discretion, patient will receive one of the following cytotoxics: topotecan, paclitaxel, gemcitabine or liposomal doxorubicin

Drug: Paclitaxel; Drug: Gemcitabine; Drug: Topotecan; Drug: Pegylated liposomal doxorubicin (PLD)

Interventions

Paclitaxel DRUG

Patients receive paclitaxel in a 4 week schedule

Cytotoxic

Gemcitabine DRUG

Patients receive gemcitabine in a 3 week schedule

Cytotoxic

Topotecan DRUG

Patients receive topotecan in 3 or 4 week schedule

Cytotoxic

Pegylated liposomal doxorubicin (PLD) DRUG

Patients receive PLD in a 4 week schedule

Cytotoxic

BI 6727 DRUG

Patients receive BI 6727 infusion every 3 weeks

BI 6727

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed recurrent epithelial ovarian carcinoma, peritoneal carcinoma or fallopian tube carcinoma.
• Platinum resistant or platinum refractory disease.
• Eastern Collaborative Oncology Group performance status \< = 2.
• Life expectancy \> = 3 months.
• At least one measurable lesion (Response Evaluation Criteria In Solid Tumours version 1.1).
• Adequate hepatic, renal and bone marrow functions.
• signed written informed consent prior to admission to the study.

You may not qualify if:

• Contre-indications for cytotoxic treatment according to the Summary of Product Characteristics (Arm B).
• Clinical evidence of active brain metastasis or leptomeningeal involvement.
• Other malignancy currently requiring active therapy.
• 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).
• Hypersensitivity to one of the trial drugs or the excipients.
• Serious illness or concomitant non- oncological disease.
• Systemic anticancer therapy within 4 weeks before the start of the study.
• Evidence of ileus sor sub ileus.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (31)

1230.18.32003 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1230.18.32004 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1230.18.32002 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1230.18.32001 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1230.18.3321A Boehringer Ingelheim Investigational Site

Angers, France

Location

1230.18.3307A Boehringer Ingelheim Investigational Site

Bordeaux, France

Location

1230.18.3301A Boehringer Ingelheim Investigational Site

Caen, France

Location

1230.18.3322A Boehringer Ingelheim Investigational Site

Lille, France

Location

1230.18.3313A Boehringer Ingelheim Investigational Site

Lyon, France

Location

1230.18.3312A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1230.18.3308A Boehringer Ingelheim Investigational Site

Nice, France

Location

1230.18.3302A Boehringer Ingelheim Investigational Site

Paris, France

Location

1230.18.3314A Boehringer Ingelheim Investigational Site

Paris, France

Location

1230.18.3309A Boehringer Ingelheim Investigational Site

Pierre-Bénite, France

Location

1230.18.3305A Boehringer Ingelheim Investigational Site

Reims, France

Location

1230.18.3320A Boehringer Ingelheim Investigational Site

Saint-Brieuc, France

Location

1230.18.3311A Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

1230.18.3310A Boehringer Ingelheim Investigational Site

Toulouse, France

Location

1230.18.3315A Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, France

Location

1230.18.42101 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1230.18.42103 Boehringer Ingelheim Investigational Site

Poprad, Slovakia

Location

1230.18.34006 Boehringer Ingelheim Investigational Site

Badalona, Spain

Location

1230.18.34001 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1230.18.34005 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1230.18.34007 Boehringer Ingelheim Investigational Site

Girona, Spain

Location

1230.18.34004 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, Spain

Location

1230.18.34002 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1230.18.34003 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1230.18.46005 Boehringer Ingelheim Investigational Site

Linköping, Sweden

Location

1230.18.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1230.18.46003 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

Related Publications (2)

• 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.

  PMID: 37407274 DERIVED

• 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.

  PMID: 26755507 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Paclitaxel; Gemcitabine; Topotecan; liposomal doxorubicin; BI 6727

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: May 12, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 13, 2015
• Results First Posted: August 13, 2015

Record last verified: 2015-07

Locations

ES (7); SE (3); BE (4); SL (2); FR (15)