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

Morphotek

Status and phase

Withdrawn

Phase 2

Conditions

Resectable, Non-functioning Pituitary Adenoma

Treatments

Drug: Farletuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01203618

MORAb-003-007

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Exclusion criteria