A Study to Determine the Activity of SCH 717454 in Subjects With Osteosarcoma or Ewing's Sarcoma That Has Relapsed After Standard Systemic Therapy
Participants with resectable osteosarcoma will be randomized to one of two dose levels of
SCH 717454 to be given intravenously. These participants will first receive SCH 717454
according to randomized treatment, and have surgery performed 10 to 14 days after initial
dosing. Participants will be allowed to recover from surgery four to six weeks prior to
additional SCH 717454 administration at their randomized dose level. SCH 717454 will then
be administered on the same calendar day once every two weeks. Participants will continue
to receive SCH 717454 until disease recurrence, or until completing a year of dosing at the
same dose level assigned, whichever occurs first.
Participants with unresectable osteosarcoma or Ewing´s sarcoma will be assigned treatment to
SCH 717454 IV administered once every two weeks and will continue to receive SCH 717454
until disease progression. Participants who achieve a CR or PR after tumor evaluations may
undergo surgical resection. After surgery, participants are eligible to receive 10 mg/kg
SCH717454 until disease recurrence/progression or one year of total dosing, whichever occurs
first.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
For participants with resectable osteosarcoma: change in tumor proliferation rate.
approximately 14 days
No
United States: Food and Drug Administration
P04720
NCT00617890
February 2008
August 2013
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