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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


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
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