Status:
COMPLETED
Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Pituitary Adenomas
Prolactinomas
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study focuses on new therapies for a challenging disease in pituitary medicine, that of aggressive pituitary tumors which have limited therapeutic options beyond standard surgical, radiotherapy, ...
Detailed Description
PURPOSE The drug Lapatinib has been shown to inhibit both epidermal growth factor receptor (EGFR) and erbB2 tyrosine kinases resulting in an effective slowing of disease progression in breast cancer....
Eligibility Criteria
Inclusion
- Patients with nonfunctioning adenomas who have undergone at least one prior surgical resection and have demonstrated recurrence on MRI
- Patients with prolactinomas who are resistant to dopamine agonist therapy
- Patients with malignant pituitary tumors
- Patients with visual field deficits and/or compression of the optic chiasm must be stable for at least 6 months
Exclusion
- Patients with compromised visual fields and/or compression of the optic chiasm on MRI that has not been stable for last 6 months.
- Patients that have reduced left ventricular ejection fraction less than 50%
- Patients with moderate to severe hepatic impairment
- Patients that are pregnant or lactating
- Patients under the age of 18
- Active hepatitis
- Known previous HIV Positive
- Concurrent cancers
- Life expectancy less than one year
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00939523
Start Date
July 1 2009
End Date
December 1 2018
Last Update
January 22 2020
Active Locations (3)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114