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

  • STATUS
    Recruiting
  • End date
    Apr 21, 2027
  • participants needed
    142
  • sponsor
    Bayer
Updated on 26 July 2022

Summary

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.

Details
Condition Mixed Tumor, Malignant
Treatment BAY806946
Clinical Study IdentifierNCT03458728
SponsorBayer
Last Modified on26 July 2022

Eligibility

Yes No Not Sure

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
Adequate bone marrow, renal and liver function
patients > 16 years of age

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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