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Co-Principal Investigators: Sandra Strauss, MD, PhD University College London Rashmi Chugh , MD

ESP1/SARC025. ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP inhibitor, Niraparib and Temozolomide in Patients with Previously Treated, incurable Ewing Sarcoma . Co-Principal Investigators: Sandra Strauss, MD, PhD University College London

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Co-Principal Investigators: Sandra Strauss, MD, PhD University College London Rashmi Chugh , MD

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  1. ESP1/SARC025 ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP inhibitor, Niraparib and Temozolomide in Patients with Previously Treated, incurable Ewing Sarcoma Co-Principal Investigators: Sandra Strauss, MD, PhD University College London RashmiChugh, MD University of Michigan

  2. ESP1/SARC025 • Ewing Sarcoma PARPi Consortium (ESP) • Collaborating • SARC • Sponsor and coordinating center • Tesaro • Supporter

  3. Background • Poly(ADP-ribose) (PARP) inhibitors potentiate the activity of cytotoxic agents, particularly DNA damaging agents • Niraparib is a potent and highly selective PARP-1 and -2 inhibitor • Temozolomide (TMZ) is an alkylating agent that is used as a part of multi-agent therapy for ES • Nirapariband TMZ combination treatment causes in vivo tumor regression in patient-derived Ewing Sarcoma xenografts in mice

  4. ESP1/SARC025

  5. ESP1/SARC025 • Single arm phase I study • Cycle = 28 days • Cohort A - enroll patients at the starting doses of Niraparib (300 mg daily) and TMZ (20, 40, 60, 80, 100 and 120 mg/m2/day, days 2-6) • Anticipated number of patients: 30 - 50

  6. Primary Objective • To define the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of the PARP inhibitor Niraparib and escalating doses of Temozolomide (TMZ) in patients with pre-treated incurable Ewing sarcoma (ES)

  7. Secondary Objectives • To determine the tumor response rate (TRR) of patients with ES treated with Niraparib and TMZ • To determine the progression free survival (PFS), duration of response, 4- and 6-month PFS rate, and overall survival (OS) of patients treated with Niraparib and TMZ

  8. Secondary Objectives • To evaluate pharmacodynamic (PD) markers of response to PARP inhibition in combination with TMZ including measurement of PAR and PARP activity and γH2AX induction

  9. Inclusion Criteria • Age ≥ 13 years • Histologically confirmed Ewing sarcoma • Recurrent or refractory tumors with no known curative treatment options • ECOG Performance Status 0 – 2 • Minimum one prior chemotherapy regimen received with at least 2 of the following agents: doxorubicin, cyclophosphamide, ifosfamide, and etoposide

  10. Study Status • Contracting • In process • Anticipated completion by end of 2013 • Activation at limited sites in US and UK • Late 2013/early 2014

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