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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Resectable, Non-functioning Pituitary Adenoma

Intervention / Treatment
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* Drug: Farletuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Farletuzumab|Farletuzumab initial loading dose 5.0 mg/kg intravenous followed by 2.5 mg/kg intravenous for all subsequent doses every 2 weeks for up to 12 months.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of farletuzumab in this patient population. |  | Weekly for the first 3 months followed by every 2 weeks for 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resectable, non-functioning pituitary adenoma, Pituitary tumor, Pituitary adenoma, Pituitary macroadenoma