Clinical Trial: ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide or Irinotecan in Patients With Previously Treated, Incurable Ewing Sarcoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide or Irinotecan in Patients With Previously Treated,Incurable

Brief Summary: The purpose of this study is to define the dose-limiting toxicities and maximum tolerated dose of the poly ADP-ribose polymerase inhibitor niraparib and escalating doses of temozolomide in patients with pre-treated incurable Ewing sarcoma.

Detailed Summary:
Sponsor: Sarcoma Alliance for Research through Collaboration

Current Primary Outcome: Dose-limiting toxicity and maximum tolerated dose [ Time Frame: Approximately 24 months ]

Dose limiting toxicity describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. The maximum tolerated dose is the highest dose of a drug or treatment that does not cause unacceptable side effects.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tumor response rate of patients treated with niraparib and temozolomide. [ Time Frame: Approximately 24 months ]
    The percentage of patients whose tumor shrinks or disappears after treatment with niraparib and temozolomide.
  • Progression-free survival at 4 and 6 months of patients treated with niraparib and temozolomide [ Time Frame: Month 4 and 6 ]


Original Secondary Outcome: Same as current

Information By: Sarcoma Alliance for Research through Collaboration

Dates:
Date Received: January 21, 2014
Date Started: May 2014
Date Completion: February 2019
Last Updated: January 19, 2017
Last Verified: January 2017