ADVL1721/COG/Bayer 806946/19176: A non-randomized, open-label, multi-center, Phase I/II study of PI3K inhibitor copanlisib in pediatric patients with relapsed/refractory solid tumors or lymphoma

This study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.

Principal Investigator:
Josephine HaDuong, MD

Research Coordinator:
Dorian Chan, RN
(714) 509-8646

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  • Clinical Trial Info
  • IRB Number: 180317
  • Sponsor: COG/Bayer
  • Protocol Number: ADVL1721
  • NCT Number: NCT03458728
  • Research Type: Adolescents and Young Adults, Leukemia/Lymphoma, Recurrent/Refractory Cancer, Solid Tumors
  • Phase: II
  • Status: Active

Key Inclusion Criteria!

  • ​Age: 6 months to ≤ 21 years old at the time of study enrollment
  • Patients must have histologic verification of a solid tumor or lymphoma malignancy at diagnosis.  Phase II: patients must have histologically verified tumor at initial diagnosis and radiologically or histologically confirmed status at inclusion as indicated in the following: neuroblastoma, osteosarcoma, rhabdomyosarcoma or Ewing sarcoma. Patients with solid tumors must have measurable or evaluable (for neuroblastoma and Ewing sarcoma) disease.
  • Adequate bone marrow, renal and liver function.

Key Exclusion Criteria:

  • Active or uncontrolled infection ).
  • History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function).
  • Diabetes mellitus.
  • Uncontrolled arterial hypertension despite optimal medical management (per institutional guidelines).
  • Patients with central nervous system (CNS) malignancies.