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Study of Pasireotide in Patie...

Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin

Last Updated: 2016-07-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-06-30

Brief Summary

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This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.

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Detailed Description

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Conditions

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Pancreatic Neoplasm Pituitary Neoplasm Nelson Syndrome Ectopic ACTH Syndrome

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pasireotide LAR 60mg

Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.

Group Type EXPERIMENTAL

pasireotide LAR

Intervention Type DRUG

Investigational drug pasireotide LAR was supplied in vials with 20 mg or 40 mg powder and 2 mL vehicle was supplied in ampoules for reconstitution.

Interventions

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pasireotide LAR

Investigational drug pasireotide LAR was supplied in vials with 20 mg or 40 mg powder and 2 mL vehicle was supplied in ampoules for reconstitution.

Intervention Type DRUG

Other Intervention Names

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SOM230

Eligibility Criteria

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Inclusion Criteria

* Male and Female Patients at least 18 years old
* Patient who have rare tumors of neuroendocrine origin, such as tumors of the:

1. pancreas
2. pituitary glands
3. Nelson syndrome
4. ectopic-ACTH secreting tumor
* Patients who have failed standard of care treatment or for whom no standard of care treatment exist
* Signed Informed Consent

Exclusion Criteria

* Patients with active gallbladder disease
* Patients with any ongoing or planned anti-neoplastic or interferon therapy
* Poorly controlled diabetes mellitus
* Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers