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

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-18

Study Completion Date

2018-09-11

Brief Summary

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This study will evaluate long-term safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic NET patients, who who have not progressed during 12 months of combination therapy with pasireotide LAR and everolimus

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Detailed Description

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Conditions

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Neuroendocrine Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RAD001 + SOM230

Group Type EXPERIMENTAL

RAD001

Intervention Type DRUG

SOM230

Intervention Type DRUG

Interventions

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RAD001

Intervention Type DRUG

SOM230

Intervention Type DRUG

Other Intervention Names

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Everolimus Paseriotide

Eligibility Criteria

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Inclusion Criteria

* The patient must provide a signed Informed Consent Form (ICF) for the extension study prior to any study related procedures
* Completion of the whole treatment period of 15 months (3 months monotherapy with either pasireotide LAR or everolimus followed by a 12 months combination of pasireotide LAR/everolimus) in the CSOM230F2102 study
* No tumor progression during 12 months of combination therapy with pasireotide LAR and everolimus (checked via radiologically assessment).

No intolerable toxicity during combination therapy with pasireotide LAR and everolimus

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No