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 ]
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