Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs (COOPERATE-1)

Novartis

Status and phase: Completed; Phase 1

Conditions: Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System

Treatments: Drug: Everolimus followed by Pasireotide LAR + Everolimus; Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01263353

2010-018895-26 (EudraCT Number)

CSOM230F2102

Details and patient eligibility

About

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).

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

Functional tumors, pre-treated

Experimental group

Treatment:

Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus

Functional tumors, treatment naïve

Experimental group

Treatment:

Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus

Nonfunctional tumors, pretreated 1

Experimental group

Treatment:

Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus

Nonfunctional tumors, pretreated 2

Experimental group

Treatment:

Drug: Everolimus followed by Pasireotide LAR + Everolimus

Nonfunctional tumors, treatment-naïve 1

Experimental group

Treatment:

Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus

Nonfunctional tumors, treatment-naïve 2

Experimental group

Treatment:

Drug: Everolimus followed by Pasireotide LAR + Everolimus