Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Pasireotide; Sirolimus; Somatostatin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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