Clinical trial NCT02155582 (phase 1, status: completed)
Conditions: non hodgkin lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: copanlisib (bay80-6946)
SMILES: COC1=C(OCCCN2CCOCC2)C=CC2=C1N=C(NC(=O)C1=CN=C(N)N=C1)N1CCN=C21
Eligibility criteria:

        -  Histologically confirmed diagnosis of the following NHL: follicular lymphoma all
             grades, lymphoplasmacytic lymphoma / Waldenström macroglobulinemia, transformed
             indolent lymphoma, diffuse large B-cell lymphoma, Burkitt lymphoma, mantle cell
             lymphoma, or peripheral T-cell lymphoma, relapsed or refractory, with 1 or more prior
             chemo-immunotherapy- or immunotherapy-based regimen(s) OR

          -  Advanced and / or refractory solid tumors with high prevalence (≥30%) of PIK3CA or
             PTEN alteration: Breast and uterine cancers (endometrium cancers but also
             non-endometrial uterine cancers), lung (squamous cell only), cervical, head and neck,
             prostate, and ovarian cancers

          -  Biopsy-accessible tumor

          -  Male or female patients equal 18 or more years of age

          -  NHL patients must have at least 1 bi-dimensionally measurable lesion according to the
             modified Cheson criteria. Patients with solid tumors must have at least 1 solid tumor
             lesion measurable by computed tomography or magnetic resonance imaging according to
             the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria

          -  Eastern Cooperative Oncology Group performance status 2 or <

          -  Life expectancy of at least 3 months

          -  Adequate bone marrow, liver, and renal functions as assessed by laboratory
             requirements conducted within 7 days before the first dose of study drug

          -  Left ventricular ejection fraction > or equal the lower limit of normal for the
             institution

        Exclusion Criteria:

          -  Previous or concurrent cancer that is distinct in primary site or histology from NHL
             or the solid tumor, for which the patient is enrolled into this study, within 5 years
             before treatment start EXCEPT for curatively treated cervical cancer in situ,
             non-melanoma skin cancer, in situ breast cancer, in situ prostate carcinoma if Gleason
             score < or equal to 6 and prostate-specific antigen <10 ng/mL, and superficial bladder
             tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina
             propria)]

          -  Known lymphomatous involvement of the brain or leptomeningeal involvement; solid tumor
             patients with central nervous system (CNS) metastases if treatment completed <3 months
             before enrollment or lesions unstable or progressing on magnetic resonance imaging
             scans performed within 1 month of enrollment or unstable symptoms of the CNS
             metastases

          -  Any illness or medical condition that is unstable or could jeopardize the safety of
             the patient or his / her compliance in the study

          -  Current diagnosis of type 1 or type 2 diabetes mellitus with HbA1c < or equal to 8.5%
             or fasting blood glucose < or equal to 160 mg/dL