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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01203618
Recruitment Status : Withdrawn (Trial terminated due to focus of primary therapeutic areas.)
First Posted : September 16, 2010
Last Update Posted : November 4, 2013
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Resectable, Non-functioning Pituitary Adenoma Drug: Farletuzumab Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Phase 2 Study of Farletuzumab in Resectable Non-functioning Pituitary Adenoma
Study Start Date : February 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: 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.
    Other Name: MORAb-003

Primary Outcome Measures :
  1. Efficacy of farletuzumab in subjects with resectable, non-functioning pituitary macroadenomas as measured by objective response in the tumor size. [ Time Frame: Every 3 months ]

Secondary Outcome Measures :
  1. Safety and tolerability of farletuzumab in this patient population. [ Time Frame: Weekly for the first 3 months followed by every 2 weeks for 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203618

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Study Director: Bruce Wallin, MD Morphotek
Principal Investigator: Nelson Oyesiku, MD, PhD, FACS Emory University

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT01203618     History of Changes
Other Study ID Numbers: MORAb-003-007
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: November 4, 2013
Last Verified: November 2013

Keywords provided by Morphotek:
Resectable, non-functioning pituitary adenoma
Pituitary tumor
Pituitary adenoma
Pituitary macroadenoma

Additional relevant MeSH terms:
Pituitary Diseases
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms