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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Islet Cell Tumor

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Treatment effect on progression-free survival (PFS) per RECIST 1.0

Outcome Description:

PFS(progression-free survival) RECIST(Response Evaluation Criteria in Solid Tumors) 80 PFS events are expected after approximately 24 months

Outcome Time Frame:

Once 80 PFS events have occurred

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSOM230I2201

NCT ID:

NCT01374451

Start Date:

June 2011

Completion Date:

March 2015

Related Keywords:

  • Islet Cell Tumor
  • Pancreatic
  • Neuroendocrine tumors
  • PNET
  • Pasireotide
  • Everolimus
  • Advanced progressive pancreatic neuroendocrine tumor
  • Neuroendocrine Tumors
  • Adenoma, Islet Cell

Name

Location

MD Anderson Cancer Center/University of Texas UT MD Anderson Cancer CtrHouston, Texas  77030-4009
Dana Farber Cancer Institute SC-2Boston, Massachusetts  02115
Montefiore Medical Center MMCBronx, New York  10467
Oregon Health & Science University Knight Cancer InstitutePortland, Oregon  97239