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Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients

Trial Status: Active

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.

Inclusion Criteria

  • Signed informed consent form by patients and/or patients' parents/legal guardians and age appropriate assent form by the patients obtained before any study specific procedure
  • Male or female patients from 6 months to ≤ 21 years old at the time of study enrollment
  • Confirmation of diagnosis:
  • Phase I: Patients must have histologic verification of a solid tumor or lymphoma malignancy at diagnosis, with measurable or evaluable disease, for which there is no standard curative anti-cancer treatment or treatment is no longer effective and must have received ≥ 1 prior line of therapy.
  • 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.
  • In Phase II, patients with solid tumors must have measurable disease (evaluable disease is acceptable for neuroblastoma and Ewing sarcoma). Tumor assessment will be done via computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography-computed tomography (PET-CT). Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion. Bone scans (if clinically indicated) should be obtained within ≤ 4 weeks prior to the start of treatment.
  • Performance level: Lansky ≥ 50% for patients ≤ 16 years of age and Karnofsky ≥ 50% for patients > 16 years of age.
  • Adequate bone marrow, renal and liver function.

Exclusion Criteria

  • Active or uncontrolled infection (National Cancer Institute (NCI)-CTCAE Grade ≥ 2).
  • History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).
  • Diabetes mellitus.
  • Uncontrolled arterial hypertension despite optimal medical management (per institutional guidelines).
  • Patients with central nervous system (CNS) malignancies.

Colorado

Aurora
Children's Hospital Colorado
Status: ACTIVE

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: APPROVED

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Anne Bubnick
Phone: 317-948-0101
Riley Hospital for Children
Status: ACTIVE
Contact: Anne Bubnick
Phone: 317-948-0101

Massachusetts

Boston
Boston Children's Hospital
Status: ACTIVE
Contact: Steven G. DuBois
Phone: 617-632-5460
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Steven G. DuBois
Phone: 617-632-5460

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: APPROVED

Tennessee

Memphis
Saint Jude Children's Research Hospital
Status: ACTIVE

Texas

Houston
Texas Children's Hospital
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Bayer Corporation

  • Primary ID 19176
  • Secondary IDs NCI-2018-00809, 2017-000383-15
  • Clinicaltrials.gov ID NCT03458728