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

Primary Purpose

Resectable, Non-functioning Pituitary Adenoma

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Farletuzumab

About this trial

This is an interventional treatment trial for Resectable, Non-functioning Pituitary Adenoma focused on measuring Resectable, non-functioning pituitary adenoma, Pituitary tumor, Pituitary adenoma, Pituitary macroadenoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

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

Sites / Locations

Emory University

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety and tolerability of farletuzumab in this patient population.

Full Information

NCT ID

NCT01203618

First Posted

July 28, 2010

Last Updated

November 1, 2013

Sponsor

Morphotek

1. Study Identification

Unique Protocol Identification Number

NCT01203618

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Trial terminated due to focus of primary therapeutic areas.

Study Start Date

February 2011 (undefined)

Primary Completion Date

June 2013 (Anticipated)

Study Completion Date

August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Morphotek

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Resectable, Non-functioning Pituitary Adenoma

Keywords

Resectable, non-functioning pituitary adenoma, Pituitary tumor, Pituitary adenoma, Pituitary macroadenoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Farletuzumab

Other Intervention Name(s)

MORAb-003

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

Every 3 months

Secondary Outcome Measure Information:

Title

Safety and tolerability of farletuzumab in this patient population.

Time Frame

Weekly for the first 3 months followed by every 2 weeks for 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce Wallin, MD

Organizational Affiliation

Morphotek

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Nelson Oyesiku, MD, PhD, FACS

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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