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LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01015118
First Posted: November 18, 2009
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
Results First Submitted: November 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Conditions: Ovarian Neoplasms
Peritoneal Neoplasms
Interventions: Drug: Placebo
Drug: Paclitaxel
Drug: BIBF 1120
Drug: Carboplatin

  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
1366 patients were randomised for this study.

Reporting Groups
  Description
Nintedanib Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
Placebo Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.

Participant Flow:   Overall Study
    Nintedanib   Placebo
STARTED   911   455 
COMPLETED   242 [1]   128 [1] 
NOT COMPLETED   669   327 
Protocol Violation                5                6 
Withdrawal by Subject                103                27 
Other Adverse Event (AE)                141                33 
Worsening or AE of underlying disease                5                4 
Progressive disease                364                229 
Not treated                9                5 
Other than stated above                42                23 
[1] Patients who completed max trial therapy duration.



  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.
Randomised Set (RS): included all randomised patients, regardless of whether or not they had received treatment. Patients were assigned to nintedanib or placebo as randomised.

Reporting Groups
  Description
Nintedanib Patients to receive Nintedanib 200 milligram (mg) soft gelatine capsule, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
Placebo Patients to receive matching placebo soft gelatine capsule identical to those containing Nintedanib, taken orally twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
Total Total of all reporting groups

Baseline Measures
   Nintedanib   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 911   455   1366 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.5  (11.0)   56.9  (11.1)   57.3  (11.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      911 100.0%      455 100.0%      1366 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
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1.  Primary:   PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.   [ Time Frame: First drug administration to date of disease progression or death whichever occurs first , upto 29 months ]

2.  Primary:   PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis).   [ Time Frame: First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months ]

3.  Secondary:   PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint).   [ Time Frame: First drug administration to date of disease progression or death whichever occurs first , upto 29 months ]

4.  Secondary:   PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis).   [ Time Frame: First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months ]

5.  Secondary:   Overall Survival   [ Time Frame: First drug administration to date of death until final DBL 26September16, upto 62 months ]

6.  Secondary:   Time to CA-125 Tumour Marker Progression   [ Time Frame: First drug administration until final DBL 26September16, upto 62 months ]

7.  Secondary:   Objective Response Based on Investigator Assessment   [ Time Frame: First drug administration until final DBL 26September16, upto 62 months ]

8.  Secondary:   Change in Abdominal/Gastro-intestinal Symptoms Over Time   [ Time Frame: First drug administration until final DBL 26September16, upto 62 months ]

9.  Secondary:   Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.   [ Time Frame: First drug administration until final DBL 26September16, upto 62 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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01015118     History of Changes
Other Study ID Numbers: 1199.15
AGO-OVAR12 ( Other Identifier: OTHER )
2008-006831-10 ( EudraCT Number: EudraCT )
First Submitted: November 9, 2009
First Posted: November 18, 2009
Results First Submitted: November 14, 2014
Results First Posted: January 15, 2015
Last Update Posted: December 7, 2017