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

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 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.

- Patients with solid tumors must have measurable or evaluable (for neuroblastoma
and Ewing sarcoma) disease. 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.