Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET

Islet Cell Tumor Clinical Trial

— COOPERATE-1  

Official title:

A Randomized, Open-label Phase II Multicenter Study Evaluating the Efficacy of Oral Everolimus Alone or in Combination With Pasireotide LAR i.m. in Advanced Progressive Pancreatic Neuroendocrine Tumors (PNET) - The COOPERATE-2 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374451
• Other study ID #: CSOM230I2201
• Secondary ID: 2010-023183-40
• Status: Completed
• Phase: Phase 2
• First received: June 14, 2011
• Last updated: May 16, 2015
• Start date: June 2011
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHPBrazil: National Health Surveillance AgencyCanada: Health CanadaDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: National Institute of HealthJapan: Pharmaceuticals and Medical Devices AgencyNetherlands: Ministry of Health, Welfare and SportNew Zealand: MedsafeSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Islet Cell Tumor
• Neuroendocrine Tumors

Intervention

Drug:
• Everolimus
Everolimus 10 mg,qd p.o. (by mouth, daily)
• Pasireotide + Everolimus
Pasireotide LAR 60 mg q28d i.m. ( once every 28 days intramuscularly) and everolimus 10mg. qd p.o. (by mouth, daily)

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Australia	Novartis Investigative Site	Herston	Queensland
Australia	Novartis Investigative Site	St. Leonards	New South Wales
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Haine-saint-Paul
Belgium	Novartis Investigative Site	Leuven
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	São Paulo	SP
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Denmark	Novartis Investigative Site	Århus
Denmark	Novartis Investigative Site	Copenhagen N
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Clichy
France	Novartis Investigative Site	Lyon
France	Novartis Investigative Site	Marseille cedex 05
France	Novartis Investigative Site	Villejuif Cedex
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	München
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Modena	MO
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Netherlands	Novartis Investigative Site	Rotterdam
New Zealand	Novartis Investigative Site	Grafton, Auckland
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Hospitalet de LLobregat	Catalunya
Spain	Novartis Investigative Site	Madrid
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Uppsala
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Istanbul
United Kingdom	Novartis Investigative Site	Cambridge
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Manchester
United States	Dana Farber Cancer Institute SC-2	Boston	Massachusetts
United States	Montefiore Medical Center MMC	Bronx	New York
United States	University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr	Houston	Texas
United States	Oregon Health & Science University Knight Cancer Institute	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Denmark,  France,  Germany,  Hungary,  Italy,  Japan,  Netherlands,  New Zealand,  Spain,  Sweden,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment effect on progression-free survival (PFS) per RECIST 1.0	PFS(progression-free survival) RECIST(Response Evaluation Criteria in Solid Tumors); 80 PFS events are expected after approximately 24 months	Once 80 PFS events have occurred	No
Secondary	Safety and tolerability profile of Everolimus alone or in combination with Pasireotide LAR	80 PFS events are expected after approximately 24 months.	Once 80 PFS events have occurred	Yes
Secondary	Objective Response Rate (ORR) and Disease Control Rate (DCR)	80 PFS are expected after approximately 24 months	Once 80 PFS events have occurred	No
Secondary	Duration of response (DoR)	80 PFS are expected after approximately 24 months	Once 80 PFS events have occurred	No
Secondary	Overall Survival (OS)	80 PFS events expected after approximately 24 months.	Once 80 PFS events have occurred	No
Secondary	The treatment effect on PFS and to assess the predictive probability of success in a possible subsequent phase III study once 105 PFS events have been observed	105 PFS events expected after approximately 36 months	Once 105 PFS events have occurred	No