Study of Imatinib, a Platelet-derived Growth Factor Receptor Inhibitor, and LBH589, a Histone Deacetylase Inhibitor, in the Treatment of Newly Diagnosed and Recurrent Chordoma
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|ClinicalTrials.gov Identifier: NCT01175109|
Recruitment Status : Unknown
Verified December 2012 by Deric M Park MD, University of Virginia.
Recruitment status was: Active, not recruiting
First Posted : August 4, 2010
Last Update Posted : December 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chordoma||Drug: Imatinib + LBH589||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Phase I Study of Imatinib, a Platelet-derived Growth Factor Receptor Inhibitor, and LBH589, a Histone Deacetylase Inhibitor, in the Treatment of Newly Diagnosed and Recurrent Chordoma|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Experimental: Escalating doses of imatinib and LBH589
Study will incorporate a "3+3" dose escalation design.
Drug: Imatinib + LBH589
Escalating doses of imatinib and LBH589 will be administered.
- Number of dose limiting toxicities [ Time Frame: At time of study drug discontinuation ]
- Tumor response [ Time Frame: Week 7 ]Tumor response will be evaluated using the RECIST criteria
- Tumor response [ Time Frame: Week 12 ]Tumor response will be evaluated using the RECIST criteria.
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): NCT01175109
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Deric M Park, MD||University of Virginia|