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

Resectable, Non-functioning Pituitary Adenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01203618
• Other study ID #: MORAb-003-007
• Status: Withdrawn
• Phase: Phase 2
• First received: July 28, 2010
• Last updated: November 1, 2013
• Start date: February 2011
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Morphotek
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adenoma
• Pituitary Diseases
• Pituitary Neoplasms
• Resectable, Non-functioning Pituitary Adenoma

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Morphotek

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of farletuzumab in subjects with resectable, non-functioning pituitary macroadenomas as measured by objective response in the tumor size.		Every 3 months	Yes
Secondary	Safety and tolerability of farletuzumab in this patient population.		Weekly for the first 3 months followed by every 2 weeks for 12 months	Yes