Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET - Full Text View

Purpose

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

Condition	Intervention	Phase
Islet Cell Tumor	Drug: Everolimus Drug: Pasireotide + Everolimus	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: Ewing sarcoma

MedlinePlus related topics: Cancer

Drug Information available for: Sirolimus Everolimus Temsirolimus Pasireotide

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Treatment effect on progression-free survival (PFS) per RECIST 1.0 [ Time Frame: Once 80 PFS events have occurred ] [ Designated as safety issue: No ]
PFS(progression-free survival) RECIST(Response Evaluation Criteria in Solid Tumors)

80 PFS events are expected after approximately 24 months

Secondary Outcome Measures:

Safety and tolerability profile of Everolimus alone or in combination with Pasireotide LAR [ Time Frame: Once 80 PFS events have occurred ] [ Designated as safety issue: Yes ]
80 PFS events are expected after approximately 24 months.
Objective Response Rate (ORR) and Disease Control Rate (DCR) [ Time Frame: Once 80 PFS events have occurred ] [ Designated as safety issue: No ]
80 PFS are expected after approximately 24 months
Duration of response (DoR) [ Time Frame: Once 80 PFS events have occurred ] [ Designated as safety issue: No ]
80 PFS are expected after approximately 24 months
Overall Survival (OS) [ Time Frame: Once 80 PFS events have occurred ] [ Designated as safety issue: No ]
80 PFS events expected after approximately 24 months.
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 [ Time Frame: Once 105 PFS events have occurred ] [ Designated as safety issue: No ]
105 PFS events expected after approximately 36 months

Enrollment:	199
Study Start Date:	June 2011
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Paseriotide LAR + Everolimus Paseriotide LAR (SOM230 LAR)+ Everolimus (RAD001)	Drug: Pasireotide + Everolimus Pasireotide LAR 60 mg q28d i.m. ( once every 28 days intramuscularly) and everolimus 10mg. qd p.o. (by mouth, daily) Other Name: SOM230 LAR + RAD001
Experimental: Everolimus	Drug: Everolimus Everolimus 10 mg,qd p.o. (by mouth, daily) Other Name: RAD001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374451

Show 47 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01374451 History of Changes
Other Study ID Numbers:	CSOM230I2201, 2010-023183-40
Study First Received:	June 14, 2011
Last Updated:	March 7, 2013
Health Authority:	United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Directorate general for the protection of Public health: Medicines Brazil: National Health Surveillance Agency Canada: Health Canada Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Italy: National Institute of Health Japan: Pharmaceuticals and Medical Devices Agency Netherlands: Ministry of Health, Welfare and Sport New Zealand: Medsafe Spain: Spanish Agency of Medicines

Keywords provided by Novartis:

Pancreatic
Neuroendocrine tumors
PNET

Pasireotide
Everolimus
Advanced progressive pancreatic neuroendocrine tumor

Additional relevant MeSH terms:

Neuroendocrine Tumors
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases

Pancreatic Diseases
Endocrine System Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013

Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET (COOPERATE-1)