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Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs

NCT ID: NCT01263353

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-03-31

Brief Summary

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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 (NET).

Detailed Description

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Conditions

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Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System

Keywords

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Carcinoid tumor, Gastroenteropancreatic Neuroendocrine Tumors, Pulmonary Neuroendocrine Tumors, pasireotide LAR, SOM230 LAR, everolimus, RAD001, Advanced Neuroendocrine Tumor, Gastroenteropancreatic System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Functional tumors, pre-treated

Group Type EXPERIMENTAL

Pasireotide LAR followed by Pasireotide LAR + Everolimus

Intervention Type DRUG

Functional tumors, treatment naïve

Group Type EXPERIMENTAL

Pasireotide LAR followed by Pasireotide LAR + Everolimus

Intervention Type DRUG

Nonfunctional tumors, pretreated 1

Group Type EXPERIMENTAL

Pasireotide LAR followed by Pasireotide LAR + Everolimus

Intervention Type DRUG

Nonfunctional tumors, pretreated 2

Group Type EXPERIMENTAL

Everolimus followed by Pasireotide LAR + Everolimus

Intervention Type DRUG

Nonfunctional tumors, treatment-naïve 1

Group Type EXPERIMENTAL

Pasireotide LAR followed by Pasireotide LAR + Everolimus

Intervention Type DRUG

Nonfunctional tumors, treatment-naïve 2

Group Type EXPERIMENTAL

Everolimus followed by Pasireotide LAR + Everolimus

Intervention Type DRUG

Interventions

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Pasireotide LAR followed by Pasireotide LAR + Everolimus

Intervention Type DRUG

Everolimus followed by Pasireotide LAR + Everolimus

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Bad Berka, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Marburg, , Germany

Site Status

Novartis Investigative Site

Münster, , Germany

Site Status

Countries

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Germany

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13569

Results for CSOM230F2102 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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2010-018895-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSOM230F2102

Identifier Type: -

Identifier Source: org_study_id