BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01314105
First received: March 8, 2011
Last updated: July 23, 2015
Last verified: July 2015
Results First Received: November 14, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Neoplasms
Peritoneal Neoplasms
Interventions: Drug: BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Drug: BIBF 1120+ PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min

  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
No text entered.

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
Nintedanib 150mg Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
Nintedanib 200mg Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.

Participant Flow:   Overall Study
    Nintedanib 150mg     Nintedanib 200mg  
STARTED     7     6  
COMPLETED     1 [1]   2 [1]
NOT COMPLETED     6     4  
Progressive Disease                 6                 4  
[1] On treatment at analysis cut off date of 15 April 2014



  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 which included all patients who were administered at least one dose of any study medication

Reporting Groups
  Description
Nintedanib 150mg Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
Nintedanib 200mg Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
Total Total of all reporting groups

Baseline Measures
    Nintedanib 150mg     Nintedanib 200mg     Total  
Number of Participants  
[units: participants]
  7     6     13  
Age  
[units: years]
Median (Full Range)
  63   (36 to 71)     53   (40 to 58)     55   (36 to 71)  
Gender  
[units: participants]
     
Female     7     6     13  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose of Nintedanib Based on the Occurrence of DLTs During Treatment Course 1   [ Time Frame: 28 days ]

2.  Secondary:   Area Under the Curve of PLD   [ Time Frame: 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration ]

3.  Secondary:   The Maximum Measured Plasma Concentration of PLD   [ Time Frame: 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration ]

4.  Secondary:   Area Under the Curve of Carboplatin   [ Time Frame: 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, 34h, 48h, 168h, 336h and 480h after drug administration ]

5.  Secondary:   The Maximum Measured Plasma Concentration of Carboplatin   [ Time Frame: 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, 34h, 48h, 168h, 336h and 480h after drug administration ]

6.  Secondary:   Area Under the Curve of Nintedanib   [ Time Frame: 5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration ]

7.  Secondary:   The Maximum Measured Plasma Concentration of Nintedanib   [ Time Frame: 5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration ]

8.  Secondary:   Frequency of All Adverse Events Graded by CTCAE (Common Terminology Criteria for Adverse Events) Version 3.0   [ Time Frame: From the first drug administration until 28 days after the last drug administration, up to 50 months ]

9.  Secondary:   Change From Baseline in Safety Laboratory Parameters   [ Time Frame: From the first drug administration until 28 days after the last drug administration, up to 50 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
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  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 Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01314105     History of Changes
Other Study ID Numbers: 1199.119, 2010-022523-30
Study First Received: March 8, 2011
Results First Received: November 14, 2014
Last Updated: July 23, 2015
Health Authority: Spain: Spanish Agency of Medicines