A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors (NCT03070301) | Clinical Trial Compass
CompletedPhase 2
A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors
United States21 participantsStarted 2017-02-27
Plain-language summary
The purpose of this study is to test any good and bad effects of the combination of LEE011 with everolimus on the participant and the cancer.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient has signed the Informed Consent prior to any screening procedures being performed and is able to comply with the protocol requirements.
* Adults ≥ 18 years old
* Histologic or cytologic diagnosis of a WDNET, Ki67 ≤ 30%, unresectable, of foregut origin (thymic, bronchopulmonary, gastric, duodenal, and pancreatic) confirmed by the enrolling institution
\*Note: If patients have a functional NET, they are permitted to continue on a somatostatin analog for hormonal symptom control
* MSK patient has tissue available from a previous biopsy for the evaluation of potential predictive biomarkers. If tissue is not available for MSK patient, a new tumor specimen will need to be obtained prior to the start of study treatment If archived tissue is available, participating site patient will provide for the evaluation of potential predictive biomarkers. If tissue is not available for participating site patient, a new tumor specimen is optional prior to the start of study treatment.
* Documented radiological evidence for disease progression (measurable or nonmeasurable) ≤12 months prior to enrollment
* Disease that is currently not amenable to surgical resection with curative intent as determined by the treating investigator
* Measurable disease as defined by RECIST v1.1
* ECOG performance status 0 or 1 or KPS performance status 100 to 70
* Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening:
* Abs…