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

Phase 1

Completed

• Conditions: Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
• Interventions: Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus; Drug: Everolimus followed by Pasireotide LAR + Everolimus

• Registration Number: NCT01263353
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-17
• Study First Posted: 2010-12-20
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2016-04
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional tumors, pre-treated	Pasireotide LAR followed by Pasireotide LAR + Everolimus	-
Nonfunctional tumors, treatment-naïve 1	Pasireotide LAR followed by Pasireotide LAR + Everolimus	-
Nonfunctional tumors, treatment-naïve 2	Everolimus followed by Pasireotide LAR + Everolimus	-
Nonfunctional tumors, pretreated 1	Pasireotide LAR followed by Pasireotide LAR + Everolimus	-
Nonfunctional tumors, pretreated 2	Everolimus followed by Pasireotide LAR + Everolimus	-
Functional tumors, treatment naïve	Pasireotide LAR followed by Pasireotide LAR + Everolimus	-

Primary Outcome Measures

Name	Time	Method
Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET	3 months

Secondary Outcome Measures

Name	Time	Method
Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET	15 months
To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy	15 months
To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy	12 months
To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus	15 months
To assess symptom control (bowel movements and flushing episodes) with pasireotide LAR in combination with everolimus in patients with functioning tumors	15 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Muenster, Germany