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

This study has been withdrawn prior to enrollment.
(Trial terminated due to focus of primary therapeutic areas.)
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT01203618
First received: July 28, 2010
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Resectable, Non-functioning Pituitary Adenoma
Drug: Farletuzumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploratory Phase 2 Study of Farletuzumab in Resectable Non-functioning Pituitary Adenoma

Resource links provided by NLM:


Further study details as provided by Morphotek:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: February 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: MORAb-003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203618

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Morphotek
Investigators
Study Director: Bruce Wallin, MD Morphotek
Principal Investigator: Nelson Oyesiku, MD, PhD, FACS Emory University
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT01203618     History of Changes
Other Study ID Numbers: MORAb-003-007
Study First Received: July 28, 2010
Last Updated: November 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Morphotek:
Resectable, non-functioning pituitary adenoma
Pituitary tumor
Pituitary adenoma
Pituitary macroadenoma

Additional relevant MeSH terms:
Adenoma
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Pituitary Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 29, 2014