Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET (COOPERATE-2)

Novartis

Status and phase: Terminated; Phase 2

Conditions: Islet Cell Tumor

Treatments: Drug: Pasireotide LAR; Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01374451

2010-023183-40 (EudraCT Number)

CSOM230I2201

Details and patient eligibility

About

This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET.

A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet its primary objective, which was based on progression-free survival (PFS) as per local radiology assessment and was prematurely terminated with the last patient last visit on 19-Feb-2015. However, it is important to note that the data did not reveal any new safety concerns. It was decided to stop the study and this decision was shared with the study sites on 31-Jul-2014.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced histologically confirmed well differentiated pancreatic neuroendocrine tumor
• Progressive disease within the last 12 months
• Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic CT

Exclusion criteria

• Patients currently requiring somatostatin analog treatment
• Prior therapy with mTOR inhibitors or pasireotide
• Patients with more than 2 prior systemic treatment regimens
• Previous cytotoxic chemotherapy, targeted therapy, somatostatin analogs, or biotherapy within the last 4 weeks

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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160 participants in 2 patient groups

Paseriotide LAR + Everolimus

Experimental group

Description:

everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im

Treatment:

Drug: Everolimus

Drug: Pasireotide LAR

Everolimus

Experimental group

Description:

everolimus 10 mg once daily po alone

Treatment:

Drug: Everolimus