ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and/or Irinotecan Patients With Previously Treated, Incurable Ewing Sarcoma
NCT02044120 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2021-01-12
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 and/or irinotecan in patients with pre-treated incurable Ewing sarcoma.
Conditions
- Ewing Sarcoma
Interventions
- DRUG
-
niraparib
- DRUG
- DRUG
Sponsors & Collaborators
-
Sarcoma Alliance for Research through Collaboration
lead OTHER
Principal Investigators
-
Rashmi Chugh, MD · University of Michigan
-
Sandra Strauss, MBBS, PhD · University College London, Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-31
- Primary Completion
- 2021-01-31
- Completion
- 2021-01-31
Countries
- United States
- United Kingdom
Study Locations
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