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

Exploring Onivyde with other drugs for kids with certain tumors.

Recruiting
12-30 years
All
Phase 1/2

This study is for kids and young adults with solid tumors that came back after treatment or never fully went away. It tests two medicine combinations to find the highest safe doses. One group (Arm A) gets Onivyde and talazoparib, and the other (Arm B) gets Onivyde and temozolomide. Onivyde damages the cancer cell's DNA, and talazoparib or temozolomide stops the cell from fixing the damage, which may kill the cancer cells. The goal is to see if these medicines help the tumors go away.

  • The study lasts up to 24 months with medicine given on specific days and regular check-ups.
  • Participants will be randomly placed in one of two groups to receive different medicine combinations.
  • There is a focus on safety and determining the best doses of the medications.

The study includes children and young people aged 12 months to 30 years old. Participants must have a specific type of tumor that cannot be cured otherwise. Regular check-ups will help monitor any side effects or changes in the tumor. This study could help find new ways to treat these tough cancers.

Study details
    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

NCT04901702

St. Jude Children's Research Hospital

4 July 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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