An Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
Both
Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
Trial Information
An Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study
Inclusion Criteria:
- Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic
neuroendocrine tumor
- Progressive disease within last 12 months (only patients with nonfunctional tumors)
- Documented liver metastasis
- Measurable disease per RECIST determined by multiphase MRI or triphasic CT
Exclusion Criteria:
- Previous treatment with radiolabeled somatostatin analogs within 12 months prior to
reporting baseline symptoms
- Previous treatment with mTOR inhibitors or pasireotide
- Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study
- Women who are pregnant or lactating
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:
Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET
Outcome Time Frame:
3 months
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CSOM230F2102
NCT ID:
NCT01263353
Start Date:
November 2010
Completion Date:
December 2014
Related Keywords:
- Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
- Carcinoid tumor,
- Gastroenteropancreatic Neuroendocrine Tumors,
- Pulmonary Neuroendocrine Tumors,
- pasireotide LAR,
- SOM230 LAR,
- everolimus,
- RAD001,
- Advanced Neuroendocrine Tumor,
- Gastroenteropancreatic System
- Neuroendocrine Tumors
- Intestinal Neoplasms
- Pancreatic Neoplasms
- Stomach Neoplasms
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