BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01121406
First received: April 13, 2010
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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)


Condition Intervention Phase
Ovarian Neoplasms
Drug: Paclitaxel
Drug: Gemcitabine
Drug: Topotecan
Drug: Pegylated liposomal doxorubicin (PLD)
Drug: BI 6727
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus Investigator´s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Disease Control Rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Progression free survival. Overall survival. Best overall response. Biological tumour response and biological progression free survival assessed by CA-125 according to the Gynecologic Cancer Intergroup. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Assessment of adverse events according to the NCI CTCAE v.3 scale: - physical examination, - vital signs - laboratory tests [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic study of BI 6727 in arm A: Maximum measured concentration in plasma. Time to maximum concentration in the plasma. Terminal half life. Area under the curve Mean residence time. Total clearance. Apparent volume of distribution. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Biomarkers and pharmacogenetics study (optional) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: April 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 6727
Patients receive BI 6727 infusion every 3 weeks
Drug: BI 6727
Patients receive BI 6727 infusion every 3 weeks
Active Comparator: Cytotoxic
At the investigator discretion, patient will receive one of the following cytotoxics: topotecan, paclitaxel, gemcitabine or liposomal doxorubicin
Drug: Paclitaxel
Patients receive paclitaxel in a 4 week schedule
Drug: Gemcitabine
Patients receive gemcitabine in a 3 week schedule
Drug: Topotecan
Patients receive topotecan in 3 or 4 week schedule
Drug: Pegylated liposomal doxorubicin (PLD)
Patients receive PLD in a 4 week schedule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Confirmed recurrent epithelial ovarian carcinoma, peritoneal carcinoma or fallopian tube carcinoma.
  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:

  1. Contre-indications for cytotoxic treatment according to the Summary of Product Characteristics (Arm B).
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121406

Locations
Belgium
1230.18.32003 Boehringer Ingelheim Investigational Site
Brussel, Belgium
1230.18.32004 Boehringer Ingelheim Investigational Site
Edegem, Belgium
1230.18.32002 Boehringer Ingelheim Investigational Site
Gent, Belgium
1230.18.32001 Boehringer Ingelheim Investigational Site
Leuven, Belgium
France
1230.18.3321A Boehringer Ingelheim Investigational Site
Angers Cedex 9, France
1230.18.3307A Boehringer Ingelheim Investigational Site
Bordeaux cedex, France
1230.18.3301A Boehringer Ingelheim Investigational Site
Caen, France
1230.18.3322A Boehringer Ingelheim Investigational Site
Lille Cedex, France
1230.18.3313A Boehringer Ingelheim Investigational Site
Lyon, France
1230.18.3312A Boehringer Ingelheim Investigational Site
Nantes cedex 02, France
1230.18.3308A Boehringer Ingelheim Investigational Site
Nice cedex, France
1230.18.3302A Boehringer Ingelheim Investigational Site
Paris, France
1230.18.3314A Boehringer Ingelheim Investigational Site
Paris Cedex 20, France
1230.18.3309A Boehringer Ingelheim Investigational Site
Pierre-Bénite cedex, France
1230.18.3305A Boehringer Ingelheim Investigational Site
Reims cedex, France
1230.18.3320A Boehringer Ingelheim Investigational Site
Saint-Brieuc cedex, France
1230.18.3311A Boehringer Ingelheim Investigational Site
Strasbourg, France
1230.18.3310A Boehringer Ingelheim Investigational Site
Toulouse Cedex 9, France
1230.18.3315A Boehringer Ingelheim Investigational Site
Vandoeuvre les Nancy cedex, France
Slovakia
1230.18.42101 Boehringer Ingelheim Investigational Site
Bratislava, Slovakia
1230.18.42103 Boehringer Ingelheim Investigational Site
Poprad, Slovakia
Spain
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
Sweden
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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01121406     History of Changes
Other Study ID Numbers: 1230.18, 2009-015770-35
Study First Received: April 13, 2010
Last Updated: June 25, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Gemcitabine
Paclitaxel
Topotecan
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators

ClinicalTrials.gov processed this record on July 23, 2014