- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01203618
Exploratory Study of Farletuzumab to Treat Resectable, Non-functioning Pituitary Adenomas
November 1, 2013 updated by: Morphotek
Exploratory Phase 2 Study of Farletuzumab in Resectable Non-functioning Pituitary Adenoma
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Every 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Weekly for the first 3 months followed by every 2 weeks for 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bruce Wallin, MD, Morphotek
- Principal Investigator: Nelson Oyesiku, MD, PhD, FACS, Emory University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Anticipated)
June 1, 2013
Study Completion (Anticipated)
August 1, 2013
Study Registration Dates
First Submitted
July 28, 2010
First Submitted That Met QC Criteria
September 15, 2010
First Posted (Estimate)
September 16, 2010
Study Record Updates
Last Update Posted (Estimate)
November 3, 2013
Last Update Submitted That Met QC Criteria
November 1, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Hypothalamic Diseases
- Hypothalamic Neoplasms
- Supratentorial Neoplasms
- Brain Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Adenoma
- Pituitary Neoplasms
- Pituitary Diseases
- Antineoplastic Agents
- Farletuzumab
Other Study ID Numbers
- MORAb-003-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Resectable, Non-functioning Pituitary Adenoma
-
Seoul National University HospitalNot yet recruitingNon-functioning Pituitary AdenomaKorea, Republic of
-
Novartis PharmaceuticalsCompleted
-
Vastra Gotaland RegionRecruitingNon-functioning Pituitary AdenomaSweden
-
Oslo University HospitalNorwegian Nurses OrganisationActive, not recruitingRenal Transplant Recipients | Non-functioning Pituitary AdenomaNorway
-
Universidade Federal do Rio de JaneiroCompletedNon-functioning Pituitary Adenomas | ProlactinomasBrazil
-
Tiburio TherapeuticsNot yet recruitingNon-Functional Pituitary Adenoma | Pituitary Tumor, Nonfunctioning
-
Zealand University HospitalNot yet recruitingNon-Functional Pituitary Adenoma
-
Asan Medical CenterUnknownPituitary ACTH Secreting AdenomaKorea, Republic of
-
Zhaoyun ZhangUnknownPituitary TumorChina
-
Samsung Medical CenterNot yet recruitingAcromegaly Due to Pituitary AdenomaKorea, Republic of
Clinical Trials on Farletuzumab
-
MorphotekCompletedEpithelial Ovarian CancerUnited States
-
Eisai Inc.Completed
-
Bristol-Myers SquibbEisai Inc.RecruitingCarcinoma, Non-Small-Cell LungUnited States, Australia, Belgium, Chile, France, Spain
-
Eisai Inc.CompletedPlatinum-Sensitive Ovarian Cancer in First RelapseUnited States, Italy, United Kingdom, Germany, Spain, Belgium, Japan
-
MorphotekCompletedEpithelial Ovarian CancerUnited States
-
MorphotekEisai Europe Ltd. (United Kingdom)TerminatedOvarian CancerUnited States, Hong Kong, Netherlands, Spain, Korea, Republic of, Belgium, Taiwan, Israel, Japan, France, United Kingdom, Singapore, Italy, Argentina, India, Germany, Hungary, Australia, Portugal, Russian Federation, Canada, Poland, Greec... and more
-
Eisai Co., Ltd.Completed
-
MorphotekTerminatedEpithelial Ovarian CancerUnited States, Germany
-
MorphotekCompletedPeritoneal Neoplasms | Ovarian Cancer | Fallopian Tube CancerUnited States, Germany
-
MorphotekTerminatedOvarian CancerCanada, United States, Netherlands, Spain, Belgium, Australia