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Exploratory Study of Farletuzumab to Treat Resectable, Non-functioning Pituitary Adenomas

NCT ID: NCT01203618

Last Updated: 2013-11-04

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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-08-31

Brief Summary

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The purpose of this study is to evaluate whether therapy with farletuzumab is effective and safe in the treatment of resectable, non-functioning pituitary adenomas.

Detailed Description

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Non-functioning pituitary adenomas are the most frequent type of pituitary tumors, defined by the lack of hormonal overproduction from the tumor. Non-functioning macroadenomas are \> 1 cm in size that can cause progressive visual loss, headaches, and symptoms of pituitary dysfunction (hypopituitarism and/or hyperprolactinemia). Initial treatment for these type of tumors is trans sphenoidal surgical resection. In cases where the outcome is incomplete surgical resection of the tumor, repeat surgery and external beam radiation therapy may be performed. Previous clinical work suggests there may be a role for a folate receptor in the treatment of non-secretory, pituitary adenomas. MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against resectable, non-functioning pituitary adenomas. MORAb-003 has been shown to be well tolerated. This study allows the opportunity to determine if therapy with farletuzumab is effective and safe.

Conditions

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Resectable, Non-functioning Pituitary Adenoma

Keywords

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Resectable, non-functioning pituitary adenoma Pituitary tumor Pituitary adenoma Pituitary macroadenoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Farletuzumab

Farletuzumab initial loading dose 5.0 mg/kg intravenous followed by 2.5 mg/kg intravenous for all subsequent doses every 2 weeks for up to 12 months.

Intervention Type DRUG

Other Intervention Names

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MORAb-003

Eligibility Criteria

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Inclusion Criteria

* Males and females \>18 years old
* Diagnosis of non-functional pituitary adenoma
* Able and willing to undergo surgical resection of the pituitary tumor
* Significant medical conditions must be well-controlled and stable for at least 30 days prior to signing the informed consent form

Exclusion Criteria

* Presence of clinically significant pituitary apoplexy
* Presence of hormone-secreting adenomas
* Presence of compressive optic neuropathy due to pituitary tumor
* No prior surgical, medical, or radiation therapy in the last 6 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Morphotek

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce Wallin, MD

Role: STUDY_DIRECTOR

Morphotek

Nelson Oyesiku, MD, PhD, FACS

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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MORAb-003-007

Identifier Type: -

Identifier Source: org_study_id