NCT01203618

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 4, 2013

Status Verified

November 1, 2013

Enrollment Period

2.3 years

First QC Date

July 28, 2010

Last Update Submit

November 1, 2013

Conditions

Resectable, Non-functioning Pituitary Adenoma

Keywords

Resectable, non-functioning pituitary adenomaPituitary tumorPituitary adenomaPituitary macroadenoma

Outcome Measures

Primary Outcomes (1)

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

    Every 3 months

Secondary Outcomes (1)

  • Safety and tolerability of farletuzumab in this patient population.

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

Interventions

FarletuzumabDRUG

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.

Also known as: MORAb-003

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

farletuzumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Bruce Wallin, MD

    Morphotek

    STUDY DIRECTOR

  • Nelson Oyesiku, MD, PhD, FACS

    Emory University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2010

First Posted

September 16, 2010

Study Start

February 1, 2011

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

November 4, 2013

Record last verified: 2013-11

Locations

US(1)