1 / 10

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

gladys
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related