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

Phase 2

Withdrawn

• Conditions: Resectable, Non-functioning Pituitary Adenoma

• Registration Number: NCT01203618
• Lead Sponsor: Morphotek

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.

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 Timeline

• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Study Start: 2011-02
• Primary Completion: 2013-06
• Study Completion: 2013-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-01
• Last Update Posted: 2013-11-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy of farletuzumab in subjects with resectable, non-functioning pituitary macroadenomas as measured by objective response in the tumor size.	Every 3 months

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of farletuzumab in this patient population.	Weekly for the first 3 months followed by every 2 weeks for 12 months

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States