slide1 n.
Download
Skip this Video
Download Presentation
Co-Principal Investigators: Sandra Strauss, MD, PhD University College London Rashmi Chugh , MD

Loading in 2 Seconds...

play fullscreen
1 / 10

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


  • 73 Views
  • Uploaded on

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Co-Principal Investigators: Sandra Strauss, MD, PhD University College London Rashmi Chugh , MD' - lakeisha-lesa


Download Now 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.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
slide1

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

esp1 sarc025
ESP1/SARC025
  • Ewing Sarcoma PARPi Consortium (ESP)
    • Collaborating
  • SARC
    • Sponsor and coordinating center
  • Tesaro
    • Supporter
background
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
esp1 sarc0252
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
primary objective
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)
secondary objectives
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
secondary objectives1
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
inclusion criteria
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
study status
Study Status
  • Contracting
    • In process
    • Anticipated completion by end of 2013
  • Activation at limited sites in US and UK
    • Late 2013/early 2014
ad