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

Sponsor

Morphotek (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01203618

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

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 :

Feb 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2013

Anticipated Study Completion Date :

Aug 1, 2013

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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