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


Phase 2
18 Years
N/A
Not Enrolling
Both
Resectable, Non-functioning Pituitary Adenoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of farletuzumab in subjects with resectable, non-functioning pituitary macroadenomas as measured by objective response in the tumor size.

Outcome Time Frame:

Every 3 months

Safety Issue:

Yes

Principal Investigator

Bruce Wallin, MD

Investigator Role:

Study Director

Investigator Affiliation:

Morphotek

Authority:

United States: Food and Drug Administration

Study ID:

MORAb-003-007

NCT ID:

NCT01203618

Start Date:

February 2011

Completion Date:

August 2013

Related Keywords:

  • Resectable, Non-functioning Pituitary Adenoma
  • Resectable, non-functioning pituitary adenoma
  • Pituitary tumor
  • Pituitary adenoma
  • Pituitary macroadenoma
  • Adenoma
  • Pituitary Neoplasms

Name

Location

Emory University Atlanta, Georgia  30322