Phase 2 Kidney Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are older than 12 months and younger than 30 years old at the time of joining the study.
- For the Phase I part: People with a solid tumour (not in the brain or spinal cord) that has come back or stopped responding to treatment, and where a cure is no longer possible. The cancer must have been confirmed by a tissue sample either at first diagnosis or when it came back.
- For a specific Phase I expansion group: People (without Ewing sarcoma) whose tumour has come back or stopped responding to treatment, and whose cancer has a specific genetic change in DNA repair genes, confirmed by approved laboratory testing.
- For the Phase II part: People with Ewing sarcoma that has come back or stopped responding to treatment, with a specific confirmed genetic feature (EWSR1-FLI1 or similar rearrangement) found at first diagnosis.
- People whose disease can be measured or tracked on scans. People with bone disease or bone marrow disease only may also be eligible, though their response may be measured differently (confirm with trial site).
- People with a reasonable level of physical functioning, as assessed by standard scales used for their age group.
- People whose kidneys, liver, lungs, and bone marrow are working well enough, based on blood tests and other checks.
- People who have fully recovered from side effects of any previous cancer treatment, and who have waited the required time since their last treatment (the waiting period varies depending on the type of treatment received).
- For Phase I: People who have previously received irinotecan-based or temozolomide-based treatment may still be eligible. People who have previously received a different PARP inhibitor (not talazoparib) may also be eligible.
- Female participants who have started their periods must have a negative pregnancy test before joining, and agree to repeat pregnancy tests during the study.
- Participants who are able to have children must agree to use effective contraception throughout the study treatment.
Who may not be able to join:
- People who are pregnant or breastfeeding.
- People who are not willing or able to use two methods of contraception during treatment — one barrier method (such as a condom) and one additional method. Female participants must continue this for at least 7 months after finishing treatment; male participants must continue for at least 4 months after the last dose.
- People who are not willing to avoid donating sperm or eggs during the study and for a set period after the last dose (105 days for sperm donation; 45 days for egg donation) (confirm with trial site).
- People whose blood counts, kidney function, liver function, or lung function do not meet the minimum levels required by the study.
- People who have not waited long enough since their last cancer treatment before joining the study.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Sara Federico, MD, St. Jude Children's Research Hospital
Phone: 888-226-4343
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Phase I:To determine the recommended phase 2 doses (RP2Ds) of Onivyde combined with talazoparib (Arm A) and Onivyde combined with temozolomide (Arm B) administered to children, adolescents and young adults with refractory or recurrent solid malignancies.; Phase II:To estimate the progression-free survival (PFS) of Onivyde plus talazoparib and Onivyde plus temozolomide in patients with refractory or recurrent Ewing sarcoma.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.