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Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma

Recruiting · Phase 1, Phase 2 · NCT04901702

Conditions: Recurrent Solid Tumor, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Solid Neoplasm, Recurrent Neuroblastoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Rhabdoid Tumor, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Recurrent Wilms Tumor, Refractory Ewing Sarcoma, Refractory Hepatoblastoma, Refractory Malignant Germ Cell Tumor, Refractory Malignant Solid Neoplasm, Refractory Neuroblastoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma

At a glance

Research payments reported, 2025
$215,208
U.S. investigators named
1
Sites paid
1
Planned or actual enrollment
90

About the trial

Sponsor
St. Jude Children's Research Hospital (with Pfizer, Ipsen)
Tested
Onivyde (drug), Talazoparib (drug), Temozolomide (drug)
Dates
Started 2021-06-09; completion 2026-12-31
Results posted
Not yet

The phase I portion of this study is designed for children or adolescents and young adults (AYA) with a diagnosis of a solid tumor that has recurred (come back after treatment) or is refractory (never completely went away). The trial will test 2 combinations of therapy and participants will be randomly assigned to either Arm A or Arm B. The purpose of the phase I study is to determine the highest tolerable doses of the combinations of treatment given in each Arm. In Arm A, children and AYAs with recurrent or refractory solid tumors will receive 2 medications called Onivyde and talazoparib. Onivyde works by damaging the DNA of the cancer cell and talazoparib works by blocking the repair of…

From ClinicalTrials.gov, last updated 2026-05-19. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Ipsen Biopharmaceuticals, Inc reported $215,208 in research payments for this study in 2025 (1 payments).

Products named: Onivyde

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • Saint Jude Childrens Research Hospital $215,208

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.