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
18 Years
N/A
Both
Islet Cell Tumor
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 Ctr | Houston, Texas 77030-4009 |
| Dana Farber Cancer Institute SC-2 | Boston, Massachusetts 02115 |
| Montefiore Medical Center MMC | Bronx, New York 10467 |
| Oregon Health & Science University Knight Cancer Institute | Portland, Oregon 97239 |
