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
This is a multi-center study to assess the safety and to determine the maximum tolerated dose of the combination of imatinib and LBH589 in patients with newly diagnosed and recurrent chordoma. For the recurrent population, those patients that do not require immediate surgical resection will be eligible. Patients will be treated with 4 cycles, followed by surgical resection if possible. If indicated, surgery may take place prior to the completion of 4 cycles.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Number of dose limiting toxicities [ Time Frame: At time of study drug discontinuation ] [ Designated as safety issue: Yes ]
- Tumor response [ Time Frame: Week 7 ] [ Designated as safety issue: Yes ]Tumor response will be evaluated using the RECIST criteria
- Tumor response [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]Tumor response will be evaluated using the RECIST criteria.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|