Go to Health Care Provider version
| Diagnosis | Ewing Sarcoma, Hepatoblastoma, Neuroblastoma, Osteosarcoma, Rhabdoid Tumor, Rhabdomyosarcoma, Wilms, Sarcoma | Study Status | Open |
| Phase | I/II |
| Age | Child, Adult - (12 Months to 30 Years) | Randomisation | YES |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Onivyde: IV , Talazoparib: oral , Temozolomide: unspecified (oral or IV most likely) |
| Last Posted Update | 2024-03-19 |
| 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 seeks to test the effectiveness and best dosage for 2 different combinations of drugs in treating cancers that have come back (recurring) or never completely went away (refractory) after initial treatment. Participants will be randomly assigned to either Arm A or Arm B of the study which will determine the combination of drugs they receive.
In Arm A, participants will receive drugs called Onivyde and talazoparib.
In Arm B, participants will receive drugs called Onivyde and temozolomide.
Both combination of drugs (Onivyde + talazoparib or Onivyde + temozolomide) are expected to irreparably damage the DNA in cancer cells and lead to cancer cell death.
After the best dosages of the drug combinations are determined in Arm A and Arm B, then the study will move on to the next stage called “expansion arms”. These expansion arms treat more participants with the dosages determined in the earlier Arm A and Arm B.
There are 3 expansion arms in this study:
Arm A1: Participants with Ewing sarcoma that has come back (recurring) or never completely went away (refractory) will receive drugs called Onivyde and talazoparib.
Arm A2: Participants with cancers that have come back (recurring) or never completely went away (refractory), and their cancer has a problem with repairing DNA (identified by their doctor) will receive drugs called Onivyde and talozoparib.
Arm B1: Participants with cancers that have come back (recurring) or never completely went away (refractory) will receive drugs called Onivyde and temozolomide.
Inclusion Criteria
- Participants must be > 12 months and <30 years at the time of enrollment
- Diagnosed with cancers that have come back (recurring) or never completely went away (refractory)
- Female or male participant of reproductive potential must agree to use effective contraceptive methods at screening and throughout duration of study treatment.
- Female participants who have begun to menstruate must have a negative urine or serum pregnancy test and must be willing to have additional serum and urine pregnancy tests during the study
- Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
