Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00939523|
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : January 13, 2020
Last Update Posted : January 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pituitary Adenomas Prolactinomas||Drug: Lapatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
All participants will be asked to take Lapatinib daily for a total of six months during the research study.
All participants will be asked to take Lapatinib daily for six months during the research study.
Other Name: Tykerb
- Change in Tumor Volume [ Time Frame: baseline and at 6 months ]Tumor volume will be assessed on MRI at 6 months on therapy and compared to baseline MRI.
- Number of Participants With 50% Reduction in Prolactin Levels [ Time Frame: every month, up to 6 months ]50% reduction in prolactin level measured monthly on 6 months therapy compared to baseline level.
- % Change in Prolactin From Baseline to Study End [ Time Frame: Baseline and at 6 months ]Percent prolactin change from start of lapatinib to end of study participant participation
- ErbB Receptor Expression [ Time Frame: at 6 months ]Mean percent positive expression of EGFR and ErbB2 will be tested on pathologic tumor specimens from subjects treated with lapatinib
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939523
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Odelia Cooper, MD||Cedars-Sinai Medical Center|