deltatrials
Recruiting PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT04901702

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

A Randomized Phase I/II Study of Talazoparib or Temozolomide in Combination With Onivyde in Children With Recurrent Solid Malignancies and Ewing Sarcoma

Sponsor: Ipsen

Conditions 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 Solid Tumor 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
Interventions Onivyde Talazoparib Temozolomide
Updated 16 times since 2021 Last updated: Feb 5, 2026 Started: Jun 9, 2021 Primary completion: Dec 31, 2025 Completion: Dec 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04901702, this PHASE1/PHASE2 trial focuses on Recurrent Ewing Sarcoma and Recurrent Hepatoblastoma and remains actively recruiting participants. Sponsored by Ipsen, it has been updated 16 times since 2021, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Jul 2022 · 6 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Mar 2023 · 6 months · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~Dec 2023 · 8 months · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshot~Mar 2025 – ~Sep 2025 · 6 months · monthly snapshot~Sep 2025 – ~Jan 2026 · 4 months · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – present · 5 months · monthly snapshot

Change History

16 versions recorded

  1. Feb 2026 — Present [monthly]

    Recruiting PHASE1/PHASE2

  2. Jan 2026 — Feb 2026 [monthly]

    Recruiting PHASE1/PHASE2

    Status: Active Not Recruiting → Recruiting

  3. Sep 2025 — Jan 2026 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  4. Mar 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  5. Sep 2024 — Mar 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

▶ Show 11 earlier versions

  1. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Status: Recruiting → Active Not Recruiting · Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  2. Jan 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  3. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE1_PHASE2

  4. Apr 2023 — Dec 2023 [monthly]

    Recruiting PHASE1_PHASE2

  5. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE1_PHASE2

  6. Sep 2022 — Mar 2023 [monthly]

    Recruiting PHASE1_PHASE2

  7. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Active Not Recruiting → Recruiting

  8. Jan 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  9. Nov 2021 — Jan 2022 [monthly]

    Recruiting PHASE1_PHASE2

  10. Sep 2021 — Nov 2021 [monthly]

    Recruiting PHASE1_PHASE2

  11. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Ipsen
  • Pfizer
  • St. Jude Children's Research Hospital
Data source: St. Jude Children's Research Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations