Phase 2 Kidney Cancer Trial, Recruiting NCT04901702 Sponsor: St. Jude Children's Research Hospital Condition: Kidney Cancer
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Phase 2 Kidney Cancer Trial, Recruiting

NCT04901702
Recruiting Phase 2

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
St. Jude Children's Research Hospital
Registry
ClinicalTrials.gov
Start date
9 June 2021
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

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?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov