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Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01225887
First Posted: October 21, 2010
Last Update Posted: October 9, 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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
Results First Submitted: August 7, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Endometrial Adenocarcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Mucinous Adenocarcinoma
Endometrial Serous Adenocarcinoma
Endometrial Squamous Cell Carcinoma
Endometrial Transitional Cell Carcinoma
Endometrial Undifferentiated Carcinoma
Malignant Uterine Corpus Mixed Epithelial and Mesenchymal Neoplasm
Recurrent Uterine Corpus Carcinoma
Intervention: Drug: Nintedanib

  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
Treatment (Nintedanib)

Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nintedanib: Given PO


Participant Flow:   Overall Study
    Treatment (Nintedanib)
STARTED   37 
COMPLETED   32 
NOT COMPLETED   5 
Ineligible:required test not done                2 
Ineligible;improper pre-protocol therapy                1 
Ineligible:inadequate pathology                2 



  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.
No text entered.

Reporting Groups
  Description
Treatment (Nintedanib)

Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nintedanib: Given PO


Baseline Measures
   Treatment (Nintedanib) 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.1  (9.8) 
Age, Customized 
[Units: Participants]
Count of Participants
 
30-39 years   1 
50-59 years   4 
60-69 years   14 
70-79 years   10 
80-89 years   3 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      32 100.0% 
Male      0   0.0% 


  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: Up to 5 years ]

2.  Primary:   Objective Tumor Response   [ Time Frame: For disease that can be evaluated by physical exam,response was assessed prior to each cycle CT scan or MRI if used to follow lesion for measurable disease every other cycle up to 5 years. ]

3.  Primary:   Progression-free Survival > 6 Months   [ Time Frame: for disease that can be evaluated by physical exam, progression was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle up to 5 years. ]

4.  Secondary:   Overall Survival   [ Time Frame: From study entry to death or last contact, up to 5 years ]

5.  Secondary:   Progression Free Survival   [ Time Frame: The duration of time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Linda Gedeon for Michael Sill, PhD
Organization: NRG Oncology
phone: 716-845-1169
e-mail: lgedeon@gogstats.org


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

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01225887     History of Changes
Other Study ID Numbers: GOG-0229K
NCI-2011-02657 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000687306
GOG-DTM0906
GOG-0229K ( Other Identifier: NRG Oncology )
GOG-0229K ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: October 20, 2010
First Posted: October 21, 2010
Results First Submitted: August 7, 2017
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017