Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Dose Escalation Study of BIBF 1120 in Combination With Carboplatin and PLD in Relapsed Ovarian Cancer (OC)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01329549
First received: April 1, 2011
Last updated: November 26, 2014
Last verified: November 2014
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
Condition: Ovarian Neoplasms
Interventions: Drug: BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Drug: BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Drug: BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min

  Participant Flow
  Hide Participant Flow

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 (150 mg) + Carboplatin + PLD Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks

Participant Flow:   Overall Study
    Nintedanib (150 mg) + Carboplatin + PLD  
STARTED     2  
COMPLETED     0  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Adverse Event                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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: includes all patients who were dispensed study medication and were documented to have received at least 1 dose of study medication.

Reporting Groups
  Description
Nintedanib (150 mg) + Carboplatin + PLD Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks

Baseline Measures
    Nintedanib (150 mg) + Carboplatin + PLD  
Number of Participants  
[units: participants]
  2  
Age  
[units: years]
Mean (Standard Deviation)
  63  (1.4)  
Gender  
[units: participants]
 
Female     2  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) of Nintedanib   [ Time Frame: 28 days ]

2.  Secondary:   Maximum Measured Plasma Concentration (Cmax)   [ Time Frame: 0.5h after the start of the infusion up to 56 days ]

3.  Secondary:   Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz)   [ Time Frame: 0.5h after the start of the infusion up to 56 days ]

4.  Secondary:   Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC0-∞)   [ Time Frame: 0.5h after the start of the infusion up to 56 days ]

5.  Secondary:   Time From Dosing to the Maximum Plasma Concentration (Tmax)   [ Time Frame: 0.5h after the start of the infusion up to 56 days ]

6.  Secondary:   Terminal Half-life (t1/2)   [ Time Frame: 0.5h after the start of the infusion up to 56 days ]

7.  Secondary:   Total Plasma Clearance (CL)   [ Time Frame: 0.5h after the start of the infusion up to 56 days ]

8.  Secondary:   Apparent Volume of Distribution at Steady State (Vss)   [ Time Frame: 0.5h after the start of the infusion up to 56 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
The trial was prematurely terminated because of worldwide disruption of pegylated liposomal doxorubicin (PLD) supplies.


  More Information
  Hide More Information

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



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01329549     History of Changes
Other Study ID Numbers: 1199.117
Study First Received: April 1, 2011
Results First Received: November 14, 2014
Last Updated: November 26, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare