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| Diagnosis | Ewing Sarcoma, Hepatoblastoma, Neuroblastoma, Osteosarcoma, Rhabdoid Tumor, Rhabdomyosarcoma, Wilms, Sarcoma | Study Status | Closed to enrollment |
| Phase | I/II |
| Age | Child, Adult - (12 Months to 30 Years) | Randomisation | YES |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Drug: Onivyde (IV) + Drug: Talazoparib (oral)
Drug: Onivyde (IV) + Temozolomide: unspecified (oral or IV most likely) |
| Last Posted Update | 2026-01-20 |
| ClinicalTrials.gov # | NCT04901702 |
International Sponsor
St. Jude Children's Research Hospital
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
BC Children's Hospital - Dr. Rebecca Deyell
CHU Ste Justine - Dr Monia MarzoukiCentres
Medical contact
Rebecca Deyell
Social worker/patient navigator contact
Ilana Katz
Clinical research contact
Hem/Onc/BMT Clinical Trials Unit
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Marie-Claude Charrette
Clinical research contact
Marie Saint-Jacques
Study Description
This study is for children, teens and young adults whose solid tumors have come back or didn’t respond to treatment. It tests two different medicine combinations, and each person is randomly placed into one of two groups. Arm A uses drugs called Onivyde and talazoparib, and Arm B uses Onivyde and temozolomide. The first part of the study focuses on finding the safest doses and has now been completed. Once the safest doses are found, more patients can join “expansion arms” to see how well the treatments work, including groups for those with certain DNA-repair problems. Phase II is now open for patients with Ewing sarcoma, who will also be randomly assigned to Arm A or Arm B to test the same medicine combinations.
Inclusion Criteria
- Participants must be > 12 months and <30 years old at the time of enrollment
- Must have a type of solid tumor that has come back or not responded to treatment
- For Ewing sarcoma patients: the cancer must have come back or not responded to first treatment, and must have a confirmed EWS-related gene change
- Must be up and about at least half of waking hours
- Must meet all organ function and bloodwork requirements
- Enough time must have passed since the last doses of chemo, growth factors, biologics, radiation or other treatments
- Anyone able to have children must use effective birth control during the study. Patients who could become pregnant must have a negative pregnancy test confirmed.
- Parent/guardian and patient (if assessed to have capacity) must sign consent
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.
