Status:
COMPLETED
Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (N...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01263353
Start Date
November 1 2010
End Date
March 1 2014
Last Update
December 21 2020
Active Locations (4)
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1
Novartis Investigative Site
Bad Berka, Germany, 99438
2
Novartis Investigative Site
Berlin, Germany, 13353
3
Novartis Investigative Site
Marburg, Germany, 35039
4
Novartis Investigative Site
Münster, Germany, 48149