Resectable, Non-functioning Pituitary AdenomaPhase 2NCT01203618
Exploratory Study of Farletuzumab to Treat Resectable, Non-functioning Pituitary Adenomas
A Phase 2 study testing Farletuzumab in people with Resectable, Non-functioning Pituitary Adenoma, run by Morphotek at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable, Non-functioning Pituitary Adenoma
- What is being tested?
- Farletuzumab
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Farletuzumab
- Keywords
- Resectable, non-functioning pituitary adenoma, Pituitary tumor, Pituitary adenoma, Pituitary macroadenoma
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FarletuzumabDrug
Also called MORAb-003
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of farletuzumab in subjects with resectable, non-functioning pituitary macroadenomas as measured by objective response in the tumor size.
Measured: Every 3 months
Secondary outcomes (1)
Safety and tolerability of farletuzumab in this patient population.
Measured: Weekly for the first 3 months followed by every 2 weeks for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startFeb 2011
- Primary completionJun 2013 (estimated)
- Study completionAug 2013 (estimated)
Why it stopped: Trial terminated due to focus of primary therapeutic areas.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable, Non-functioning Pituitary AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Wallin, MD, Study director, MorphotekNelson Oyesiku, MD, PhD, FACS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203618
- Sponsor's protocol ID
- MORAb-003-007
- Status last verified
- Nov 2013
- First submitted
- 28 Jul 2010
- Last updated
- 4 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Phase 2 Study of Farletuzumab in Resectable Non-functioning Pituitary Adenoma
- ClinicalTrials.gov ID
- NCT01203618
- Acronym / sponsor ID
- MORAb-003-007
- Keywords
- Resectable, non-functioning pituitary adenoma, Pituitary tumor, Pituitary adenoma, Pituitary macroadenoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial terminated due to focus of primary therapeutic areas.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MorphotekIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FarletuzumabAlso: MORAb-003Farletuzumab 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. | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Wallin, MD study director
Morphotek
Nelson Oyesiku, MD, PhD, FACS principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Farletuzumab in people with Resectable, Non-functioning Pituitary Adenoma, run by Morphotek at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2013.