Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer
|ClinicalTrials.gov Identifier: NCT01225887|
Recruitment Status : Completed
First Posted : October 21, 2010
Results First Posted : October 9, 2017
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Nintedanib||Phase 2|
I. To estimate the proportion of patients with persistent or recurrent endometrial cancer, who survive progression-free without going on a subsequent therapy against the disease for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with BIBF 1120 (nintedanib).
II. To determine the nature and degree of toxicity of BIBF 1120 in this cohort of patients.
I. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with BIBF 1120.
Patients receive nintedanib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of BIBF 1120 in the Treatment of Recurrent or Persistent Endometrial Carcinoma|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: 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.
- Number of Participants With Adverse Events [ Time Frame: Up to 5 years ]The incidence of adverse events (grade 3 or higher) as assessed by the National Cancer Institute CTCAE version 4.0
- 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. ]Complete and Partial Tumor Response by RECIST 1.1
- 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. ]Whether or not the patient survived progression-free for at least 6 months.
- Overall Survival [ Time Frame: From study entry to death or last contact, up to 5 years ]The observed length of life from entry into the study to death or the date of last contact.
- 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 ]the period of progression free survival for patients with persistent or recurrent endometrial cancer treated with study drug.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225887
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|Principal Investigator:||Don Dizon||NRG Oncology|