Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT01455493
Eligibility Criteria:
Inclusion Criteria:
* Patients must have recurrent or persistent endometrial carcinoma that is refractory to curative therapy or established treatments
* Histologic confirmation of the original primary tumor is required
* Histologic or cytologic confirmation of the recurrent/progressive disease is desired
* Patients must have had at least one but no more than two prior chemotherapeutic regimens for management of endometrial carcinoma
* Disease that is measurable per RECIST v1.1
* No active infection requiring antibiotics
* Any hormonal therapy directed at the malignant tumor must be discontinued at least 2 weeks prior to first study treatment
* Any other prior therapy directed at the malignant tumor, including immunologic agents and radiotherapy, must be discontinued at least 2 weeks prior to first study treatment
* Adequate hematologic and end organ function
Exclusion Criteria:
* Type I diabetes or Type II diabetes requiring insulin
* Prior use of mTOR/PI3K inhibitor
* Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform activities of daily living
* Previous diagnosis of pulmonary fibrosis of any cause
* History of myocardial infarction or unstable angina within 6 months prior to first study treatment
* Congestive heart failure
* History of malabsorption syndrome or other condition that would interfere with enteral absorption
* Clinically significant history of liver disease, including cirrhosis and current alcohol abuse
* Presence of positive test results for hepatitis B or hepatitis C
* Known HIV infection
* Active autoimmune disease that is not controlled by nonsteroidal anti inflammatory drugs
* Need for current chronic corticosteroid therapy
* Pregnancy, lactation, or breastfeeding
* Current severe, uncontrolled systemic disease
* Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 or anticipation of the need for major surgery during the course of study treatment
* Uncontrolled hypercalcemia
* Leptomeningeal disease as a manifestation of cancer
* Known untreated or active brain metastases
* Grade \>=2 hypercholesterolemia or hypertriglyceridemia
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01455493
Study Brief:
Protocol Section:
NCT01455493