Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)
Condition: Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
MeSH terms: Lymphoma; Neoplasms; Multiple Myeloma
Intervention: Biopsy; Computed Tomography; Copanlisib Hydrochloride; Magnetic Resonance Imaging
Intervention description: Undergo tumor biopsy; Undergo CT; Given IV; Undergo MRI
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II MATCH treatment trial identifies the effects of copanlisib hydrochloride
      (copanlisib) in patients whose cancer has a genetic change called PIK3CA mutation. Copanlisib
      may stop the growth of cancer cells by blocking PIK3, a protein needed for cell growth.
      Researchers hope to learn if copanlisib will shrink this type of cancer or stop its growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have met applicable eligibility criteria in the Master MATCH Protocol
             prior to registration to treatment subprotocol

          -  Patients must have PIK3CA mutation as determined via the MATCH Master Protocol

          -  Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment
             assignment and must have no clinically important abnormalities in rhythm, conduction
             or morphology of resting ECG (e.g. complete left bundle branch block, third degree
             heart block)

          -  Patients should stop using herbal medications at least 7 days prior to the first dose
             of copanlisib. Herbal medications include, but are not limited to: St. John's Wort,
             Kava, ephedra, gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto,
             black cohosh and ginseng

          -  Patients with type I or II diabetes mellitus must have glycosylated hemoglobin A1c
             (HbA1c) =< 8.5% within 28 days from registration

          -  Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L

          -  Platelets >= 100x10^9/L

          -  Hemoglobin (Hb) > 9 g/dl

          -  Total serum bilirubin < 2.0 mg/dL

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper
             limit of normal (ULN) (< 5 x ULN in patients with liver metastases)

          -  Serum creatinine < 1.5 x ULN

          -  Men and women of child-bearing potential must agree to use contraception while
             receiving study treatment and for 1 month after the last dose of copanlisib

        Exclusion Criteria:

          -  Patients must not have known hypersensitivity to copanlisib or compounds of similar
             chemical or biologic composition

          -  Patients must not have had prior therapy with copanlisib or other PI3K inhibitors, AKT
             inhibitors or mTOR inhibitors

          -  Patients must not have activating KRAS mutations

          -  Patients must not have HER2 positive (3+ by immunohistochemistry [IHC] or fluorescence
             in situ hybridization [FISH] ratio >= 2) breast cancer

          -  Patients must not have indolent non-Hodgkin lymphoma (NHL) (follicular lymphoma, small
             lymphocytic lymphoma [SLL]/chronic lymphocytic leukemia [CLL], lymphoplasmacytic
             lymphoma [LPL], marginal zone lymphoma) or DLBCL (diffuse large B cell lymphoma)

          -  Patients must not be on strong inhibitors or inducers of CYP3A4 within two weeks prior
             to start of study treatment and for the duration of study treatment

          -  Patients must not be on anti-arrhythmic therapy other than digoxin or beta-blockers

          -  Patients with non-healing wound, ulcer, or bone fracture are not eligible

          -  Patients with history of or current interstitial pneumonitis are not eligible

               -  NOTE: For solid tumors, cytomegalovirus (CMV) polymerase chain reaction (PCR) can
                  be obtained at the discretion of treating physician or local institutional
                  guidelines