Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs (COOPERATE-1)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
The purpose of this study is to assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (NET).
Condition or disease
Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
Drug: Pasireotide LAR followed by Pasireotide LAR + EverolimusDrug: Everolimus followed by Pasireotide LAR + Everolimus
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic neuroendocrine tumor
Progressive disease within last 12 months (only patients with nonfunctional tumors)
Documented liver metastasis
Measurable disease per RECIST determined by multiphase MRI or triphasic CT
Previous treatment with radiolabeled somatostatin analogs within 12 months prior to reporting baseline symptoms
Previous treatment with mTOR inhibitors or pasireotide
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Women who are pregnant or lactating
Other protocol-defined inclusion/exclusion criteria may apply