BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01121406
First received: April 13, 2010
Last updated: May 15, 2013
Last verified: May 2013
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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:
Drug Information available for:
Doxorubicin
Doxorubicin hydrochloride
Paclitaxel
Gemcitabine
Topotecan hydrochloride
Gemcitabine hydrochloride
Topotecan
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
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 ]
| Estimated Enrollment: | 110 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | November 2013 |
| Primary Completion Date: | October 2011 (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:
- 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.
Exclusion criteria:
- 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.
Contacts and Locations
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, 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 Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01121406 History of Changes |
| Other Study ID Numbers: | 1230.18, 2009-015770-35 |
| Study First Received: | April 13, 2010 |
| Last Updated: | May 15, 2013 |
| 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 May 23, 2013