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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01015118
First received: November 9, 2009
Last updated: June 6, 2016
Last verified: June 2016
Results First Received: November 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Conditions: Ovarian Neoplasms
Peritoneal Neoplasms
Interventions: Drug: Placebo
Drug: Paclitaxel
Drug: BIBF 1120
Drug: Carboplatin

  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
The study is ongoing. 1366 patients were randomised for this study. The cut-off date for the primary analysis was 29 Apr 2013.

Reporting Groups
  Description
Nintedanib Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
Placebo Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken 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     270 [1]   141 [1]
NOT COMPLETED     641     314  
Worsening or AE of underlying disease                 5                 4  
Protocol Violation                 4                 5  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 98                 26  
Other Adverse Event                 138                 32  
Progressive disease                 354                 225  
Not treated                 9                 5  
Other than stated above                 32                 17  
[1] Patients completed according to protocol and Patients on treatment are considered to be completed.



  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.
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 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
Placebo Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken 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  
Number of Participants  
[units: participants]
  911     455     1366  
Age  
[units: Years]
Mean (Standard Deviation)
  57.5  (11.0)     56.9  (11.1)     57.3  (11.1)  
Gender  
[units: participants]
     
Female     911     455     1366  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

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.  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 ]

3.  Secondary:   Overall Survival   [ Time Frame: First drug administration until data cut-off 29Apr2013, upto 41 months ]

4.  Secondary:   Time to CA-125 Tumour Marker Progression   [ Time Frame: First drug administration until data cut-off 29Apr2013, upto 41 months ]

5.  Secondary:   Objective Response Based on Investigator Assessment   [ Time Frame: First drug administration until data cut-off 29Apr2013, upto 41 months ]

6.  Secondary:   Change in Abdominal/Gastro-intestinal Symptoms Over Time   [ Time Frame: First drug administration until data cut-off 29Apr2013, upto 41 months ]

7.  Secondary:   Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.   [ Time Frame: First drug administration until data cut-off 29Apr2013, upto 41 months ]


  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
No text entered.


  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


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 )
Study First Received: November 9, 2009
Results First Received: November 14, 2014
Last Updated: June 6, 2016
Health Authority: Australia: Human Research Ethics Committee
Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: The Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
France: Agence Nationale sécurité médicament et des produits santé
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Italy: Ethics Committee
Monaco: Ministère de l'Etat
Netherlands: Central Committee Research Involving Human Subjects
Norway: Norwegian Medicines Agency
Poland: Registration Medicinal Product Medical Device Biocidal Product
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Portugal: INFARMED, National Authority of Medicines and Health Products, IP