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Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer

A Phase II Trial of AMG 386, a Selective Angiopoietin 1/2 Neutralizing Peptibody, in Patients With Persistent/Recurrent Carcinoma of the Endometrium

NCT01210222•Gynecologic Oncology Group

View on ClinicalTrials.gov

Summary

This phase II trial studies the side effects and how well trebananib works in treating patients with persistent or recurrent endometrial cancer. Trebananib may stop the growth of endometrial cancer by blocking blood flow to the tumor.

Detailed Description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: I. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with AMG 386. OUTLINE: 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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Patients must have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required; stained slides to document the primary tumor as well as recurrent/persistent disease (if documented by histology or cytology) are required
•Patients with the following histologic epithelial cell types are eligible:
•* Endometrioid adenocarcinoma
•* Serous adenocarcinoma
•* Undifferentiated carcinoma
•* Clear cell adenocarcinoma
•* Mixed epithelial carcinoma
•* Adenocarcinoma not otherwise specified (N.O.S.)
•* Mucinous adenocarcinoma
•* Squamous cell carcinoma
+28 more criteria

Exclusion Criteria

•Patients who are currently or have been previously treated with trebananib, or other molecules that inhibit the angiopoietins or Tie2 receptor
•Patient with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
•Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
•Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
•Patients who are pregnant or nursing
•Patients with symptoms of partial or complete bowel obstruction; recent (within 6 months) history of fistula, intraabdominal abscess or bowel perforation; subjects requiring total parenteral nutrition or parenteral hydration
•Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including brain tumor, seizures not controlled with standard medical therapy or any brain metastases
•Patients with clinically significant cardiovascular disease; this includes:
•* Myocardial infarction or unstable angina within 12 months of the first date of study treatment
•* New York Heart Association (NYHA) Class II or greater congestive heart failure
+17 more criteria

Locations (33)

Hartford Hospital

Hartford, Connecticut, United States

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Memorial University Medical Center

Savannah, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Sudarshan K Sharma MD Limted-Gynecologic Oncology

Hinsdale, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

Saint Vincent Hospital and Health Care Center

Indianapolis, Indiana, United States

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

Key Dates

Start Date

June 6, 2011

Primary Completion Date

July 16, 2016

Completion Date

July 16, 2016

Last Updated

February 23, 2018

Enrollment

ACTUAL participants

Conditions

Endometrial AdenocarcinomaEndometrial Adenosquamous CarcinomaEndometrial Clear Cell AdenocarcinomaEndometrial Endometrioid Adenocarcinoma, Variant With Squamous DifferentiationEndometrial Serous AdenocarcinomaEndometrioid Stromal SarcomaRecurrent Uterine Corpus Carcinoma

Interventions

Trebananib

BIOLOGICAL

Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment

NCT07077876

Endometrial AdenocarcinomaEndometrial Hyperplasia+2 more

View study

ACTIVE_NOT_RECRUITINGPHASE2

Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone

NCT03660826

Endometrial AdenocarcinomaEndometrial Mixed Cell Adenocarcinoma+4 more

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer

Inclusion Criteria

Exclusion Criteria

Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment

Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone

Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care

Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer

Prognosis of METTL-14 in Endometrial Carcinoma

Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer