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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Exploratory Phase 2 Study of Farletuzumab in Resectable Non-functioning Pituitary Adenoma

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 Summary: 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.
Sponsor: Morphotek

Current Primary Outcome: 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 ]

Original Primary Outcome: To establish the 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 ]

Current Secondary Outcome: 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 ]

Original Secondary Outcome: To determine the 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 By: Morphotek

Dates:
Date Received: July 28, 2010
Date Started: February 2011
Date Completion: August 2013
Last Updated: November 1, 2013
Last Verified: November 2013