Ewing's Sarcoma Clinical Trial
Official title:
Phase II Study of the PARP Inhibitor, Olaparib, in Adult Patients With Recurrent/Metastatic Ewing's Sarcoma Following Failure of Prior Chemotherapy
This research study is a Phase II clinical trial to test the efficacy of Olaparib in adult participants with recurrent/metastatic Ewing's Sarcoma following failure of prior chemotherapy.
Primary Objectives Evaluate the objective response rate of olaparib in adult patients with
recurrent and/or metastatic Ewing's sarcoma following failure of conventional chemotherapy.
Secondary Objectives To evaluate the progression-free survival, overall survival, and safety
of olaparib in this patient population. As an exploratory objective, the investigators will
evaluate (in subjects who agree to an optional biopsy) differences in pre- and
post-treatment tumor DNA alterations and differences in levels of protein and RNA expression
related to PARP inhibition.
Study Design Potential subjects who discuss and sign the informed consent form will undergo
screening studies. Eligible patients will administer olaparib and obtain restaging imaging
studies after 6 and 12 weeks on study, and then every 8 weeks thereafter. Participants will
remain on study drug until disease progression, onset of unacceptable toxicities, or subject
withdraws consent.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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