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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sarcoma Alliance for Research through Collaboration
Study ID
NCT02044120
Phase
PHASE1
Status
Completed

Conditions

  • Ewing Sarcoma

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 31, 2014
Status verified
Jan 2021
Primary completion
Jan 31, 2021
Completion
Jan 31, 2021

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: niraparib and temozolomide
    Niraparib (capsule) and temozolomide (capsule) will be taken together.
  • Experimental: niraparib and irinotecan
    Niraparib will be taken orally and irinotecan will be administered intravenously.
  • Experimental: niraparib, irinotecan and temozolomide
    Niraparib and temozolomide will be taken orally. Irinotecan will be administered intravenously.

Primary Outcome Measure

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

Locations (4)

FacilityCityStateZIPSite coordinators
Children's Hospital of Los AngelesLos AngelesCalifornia90027-
National Cancer InstituteBethesdaMaryland20892-
University of MichiganAnn ArborMichigan48106-
Seattle's Children Cancer CenterSeattleWashington98101-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital of Los Angeles· Los Angeles, CANational Cancer Institute· Bethesda, MDUniversity of Michigan· Ann Arbor, MISeattle's Children Cancer Center· Seattle, WA

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