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

April 13, 2010
June 25, 2014
April 2010
June 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01121406 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Safety according to the NCI CTCAE v.3 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and indivudual symptoms questionnaires [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic study [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Biomarkers and pharmacogenetics study (optional) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer
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

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)

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Neoplasms
  • 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
  • Drug: BI 6727
    Patients receive BI 6727 infusion every 3 weeks
  • Experimental: BI 6727
    Patients receive BI 6727 infusion every 3 weeks
    Intervention: Drug: BI 6727
  • Active Comparator: Cytotoxic
    At the investigator discretion, patient will receive one of the following cytotoxics: topotecan, paclitaxel, gemcitabine or liposomal doxorubicin
    Interventions:
    • Drug: Paclitaxel
    • Drug: Gemcitabine
    • Drug: Topotecan
    • Drug: Pegylated liposomal doxorubicin (PLD)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Slovakia,   Spain,   Sweden
 
NCT01121406
1230.18, 2009-015770-35
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP