Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT01210222|
Recruitment Status : Completed
First Posted : September 28, 2010
Results First Posted : November 29, 2017
Last Update Posted : February 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation Endometrial Serous Adenocarcinoma Endometrioid Stromal Sarcoma Recurrent Uterine Corpus Carcinoma||Biological: Trebananib||Phase 2|
I. To estimate the proportion of patients with persistent or recurrent endometrial cancer, who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with AMG 386 (trebananib).
II. To determine the nature and degree of toxicity of AMG 386 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 AMG 386.
Patients receive trebananib intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 21. 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 :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of AMG 386, a Selective Angiopoietin 1/2 Neutralizing Peptibody, in Patients With Persistent/Recurrent Carcinoma of the Endometrium|
|Actual Study Start Date :||June 6, 2011|
|Actual Primary Completion Date :||July 16, 2016|
|Actual Study Completion Date :||July 16, 2016|
Experimental: Treatment (trebananib)
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Progression-free Survival > 6 Months [ Time Frame: At 6 months ]Whether or not the patient survived progression-free for at least 6 months.
- Objective Tumor Response (Complete or Partial Response) [ Time Frame: Up to 5 years ]Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Adverse Events as Assessed by NCI CTCAE v 4.0 [ Time Frame: Up to 5 years ]
- 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: Patients whose disease can be evaluated by physical exam, progression was assessed prior to each cycle. CT or MRI if used to follow leasion for measurable disease, up to 5 years ]The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210222
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|Principal Investigator:||Kathleen Moore||NRG Oncology|