deltatrials
Completed PHASE1 INTERVENTIONAL 3-arm NCT03434262

SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors

Molecularly-Driven Doublet Therapy for All Children With Refractory or Recurrent CNS Malignant Neoplasms and Young Adults With Refractory or Recurrent SHH Medulloblastoma

Sponsor: Novartis Pharmaceuticals

Conditions Anaplastic Astrocytoma Anaplastic Ependymoma Anaplastic Ganglioglioma Anaplastic Meningioma Anaplastic Oligodendroglioma Atypical Teratoid/Rhabdoid Tumor Brain Cancer Brain Tumor CNS Embryonal Tumor With Rhabdoid Features CNS Tumor Central Nervous System Neoplasms Choroid Plexus Carcinoma Embryonal Tumor With Multilayered Rosettes (ETMR) Embryonal Tumor of CNS Embryonal Tumor, NOS Ependymoma Ependymoma, NOS, WHO Grade II Ependymoma, NOS, WHO Grade III Ependymoma, RELA Fusion Positive Ependymoma, Recurrent Ganglioneuroblastoma of Central Nervous System Glioblastoma Glioblastoma, IDH-mutant Glioblastoma, IDH-wildtype Glioma Glioma, Diffuse Midline, H3K27M-mutant Glioma, High Grade Glioma, Malignant Glioma, Recurrent High Grade Glioma, Recurrent Malignant Medulloblastoma Medulloblastoma, Chromosome 9q Loss Medulloblastoma, G3/G4 Medulloblastoma, Group 3 Medulloblastoma, Group 4 Medulloblastoma, Non-WNT Non-SHH, NOS Medulloblastoma, Non-WNT/Non-SHH Medulloblastoma, PTCH1 Mutation Medulloblastoma, SHH-activated and TP53 Mutant Medulloblastoma, SHH-activated and TP53 Wildtype Medulloblastoma, WNT-activated Medulloblastoma; Unspecified Site Medulloepithelioma Neoplasms Neoplasms, Neuroepithelial Neuroblastoma. CNS Neuroepithelial Tumor Neuroepithelial Tumor, High Grade Papillary Tumor of the Pineal Region (High-grade Only) Pediatric Brain Tumor Pineal Parenchymal Tumor of Intermediate Differentiation (High-grade Only) Pineoblastoma Pleomorphic Xanthoastrocytoma, Anaplastic Primitive Neuroectodermal Tumor Recurrent Medulloblastoma Refractory Brain Tumor
Interventions Gemcitabine filgrastim ribociclib sonidegib trametinib
Updated 18 times since 2018 Last updated: May 30, 2024 Started: Mar 5, 2018 Primary completion: Sep 30, 2022 Completion: May 24, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Anaplastic Astrocytoma and Anaplastic Ependymoma and is currently completed. Novartis Pharmaceuticals leads this study, which shows 18 recorded versions since 2018 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshot~Feb 2019 – ~Feb 2020 · 12 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Jan 2021 · 10 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~May 2021 · 3 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~May 2022 · 8 months · monthly snapshot~May 2022 – ~Jan 2023 · 8 months · monthly snapshot~Jan 2023 – ~Jun 2023 · 5 months · monthly snapshot~Jun 2023 – ~Dec 2023 · 6 months · monthly snapshot~Dec 2023 – ~Apr 2024 · 4 months · monthly snapshot~Apr 2024 – ~Jun 2024 · 2 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

18 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jun 2024 — Jul 2024 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  4. Apr 2024 — Jun 2024 [monthly]

    Active Not Recruiting PHASE1

  5. Dec 2023 — Apr 2024 [monthly]

    Active Not Recruiting PHASE1

▶ Show 13 earlier versions

  1. Jun 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE1

  2. Jan 2023 — Jun 2023 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  3. May 2022 — Jan 2023 [monthly]

    Recruiting PHASE1

  4. Sep 2021 — May 2022 [monthly]

    Recruiting PHASE1

  5. May 2021 — Sep 2021 [monthly]

    Recruiting PHASE1

  6. Feb 2021 — May 2021 [monthly]

    Recruiting PHASE1

  7. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1

  8. Mar 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  9. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE1

  10. Feb 2019 — Feb 2020 [monthly]

    Recruiting PHASE1

  11. Jun 2018 — Feb 2019 [monthly]

    Recruiting PHASE1

  12. Apr 2018 — Jun 2018 [monthly]

    Recruiting PHASE1

  13. Mar 2018 — Apr 2018 [monthly]

    Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
  • 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