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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01374451
First received: June 14, 2011
Last updated: March 13, 2014
Last verified: March 2014
  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:


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: 160
Study Start Date: June 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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 13, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
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:
Adenoma, Islet Cell
Neuroendocrine Tumors
Adenoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Pancreatic Diseases
Pancreatic Neoplasms
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014