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: July 17, 2015
Last verified: July 2015
Results First Received: July 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Neoplasms
Interventions: Drug: Paclitaxel
Drug: Gemcitabine
Drug: Topotecan
Drug: Pegylated liposomal doxorubicin (PLD)
Drug: BI 6727

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Overall 54 patients were treated in Volasertib arm and 55 patients were treated in Cytotoxic arm. The "Not completed" category in the Subject Disposition table represents " Treatment permanently discontinued" and "The reasons for non-completion" in the table represent "Reason for treatment discontinuation".

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Volasertib (BI 6727)

Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.

Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status.

Cytotoxic

Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:

  • Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
  • Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
  • Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
  • Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)

Participant Flow:   Overall Study
    Volasertib (BI 6727)     Cytotoxic  
STARTED     55     55 [1]
COMPLETED     0     0  
NOT COMPLETED     55     55  
Progressive disease RECIST                 44                 28  
Wors. or AE of underlying cancer disease                 4                 6  
Other AE                 3                 10  
Non−compliant with protocol                 0                 2  
Lost to Follow-up                 0                 1  
Refused continuation of study med.                 1                 2  
Reason other than specified above                 2                 6  
Not treated                 1                 0  
[1] 24 patients switched to Volasertib (BI 6727) due to disease progression or occurrence of toxicity



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set (TS): The treated set consisted of all patients who received at least one administration of the trial drug.

Reporting Groups
  Description
Volasertib (BI 6727)

Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.

Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status.

Cytotoxic

Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:

  • Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)
  • Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)
  • Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)
  • Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)
Total Total of all reporting groups

Baseline Measures
    Volasertib (BI 6727)     Cytotoxic     Total  
Number of Participants  
[units: participants]
  54     55     109  
Age  
[units: years]
Mean (Standard Deviation)
  61.3  (9.88)     60.9  (9.26)     61.1  (9.53)  
Gender  
[units: participants]
     
Female     54     55     109  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1   [ Time Frame: Week 24 ]

2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From randomization until disease progression, death or study discontinuation; Up to 213 weeks ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: From randomization until death or study discontinuation; Up to 213 weeks ]

4.  Secondary:   Best Overall Response   [ Time Frame: time from the date of randomisation until study completion/discontinuation; Up to 213 weeks ]

5.  Secondary:   Biological Tumour Response Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria   [ Time Frame: At screening and every 6 weeks thereafter (Up to 213 weeks) ]

6.  Secondary:   Biological Progression-free Survival Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria   [ Time Frame: At screening and every 6 weeks thereafter (Up to 213 weeks ) ]

7.  Secondary:   Time to Deterioration in Global Health Status/Quality of Life (QOL)   [ Time Frame: Every 6 weeks (Up to 213 weeks ) ]

8.  Secondary:   Time to Deterioration in Fatigue/Quality of Life (QOL)   [ Time Frame: Every 6 weeks (Up to 213 weeks ) ]

9.  Secondary:   Time to Deterioration in Pain/ Quality of Life (QOL)   [ Time Frame: Every 6 weeks (Up to 213 weeks ) ]

10.  Secondary:   Time to Deterioration in Abdominal Bloating/ Quality of Life (QOL)   [ Time Frame: Every 6 weeks (Up to 213 weeks ) ]

11.  Secondary:   Time to Deterioration in the Three Most Troublesome Disease Specific Symptoms/ Quality of Life (QOL)   [ Time Frame: Every 6 weeks (Up to 213 weeks) ]

12.  Secondary:   Incidence and Intensity of Adverse Events According to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0   [ Time Frame: From first treatment administration to 21 days after the last drug administration (Up to 1403 days) ]

13.  Secondary:   Clinically Relevant Changes in Laboratory and ECG Data   [ Time Frame: From first treatment administration to 21 days after the last drug administration (Up to 1403 days) ]

14.  Secondary:   AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for BI 6727 BS   [ Time Frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration ]

15.  Secondary:   AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for CD 10899 BS   [ Time Frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration ]

16.  Secondary:   AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for BI 6727 BS   [ Time Frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration ]

17.  Secondary:   AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for CD 10899 BS   [ Time Frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration ]

18.  Secondary:   Cmax; Maximum Measured Concentration of BI 6727 BS in Plasma   [ Time Frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration ]

19.  Secondary:   Cmax; Maximum Measured Concentration of CD 10899 BS in Plasma   [ Time Frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration ]

20.  Secondary:   Tmax; Time From Dosing to Maximum Measured Concentration of BI 6727 BS in Plasma   [ Time Frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration ]

21.  Secondary:   Tmax; Time From Dosing to Maximum Measured Concentration of CD 10899 BS in Plasma   [ Time Frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration ]

22.  Secondary:   t1/2; Terminal Half-life of BI 6727 BS in Plasma   [ Time Frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration ]

23.  Secondary:   t1/2; Terminal Half-life of CD 10899 BS in Plasma   [ Time Frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration ]

24.  Secondary:   MRT; Mean Residence Time of BI 6727 BS in the Body   [ Time Frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration ]

25.  Secondary:   CL; Total Clearance of BI 6727 BS in Plasma After Intravenous Administration   [ Time Frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration ]

26.  Secondary:   Vss;Apparent Volume of Distribution at Steady State Following Intravenous Administration for BI 6727 BS   [ Time Frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration ]

27.  Secondary:   Biomarkers and Pharmacogenetics Analysis (Optional)   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


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
Results First Received: July 17, 2015
Last Updated: July 17, 2015
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