Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B)
Condition: Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
MeSH terms: Lymphoma; Neoplasms; Multiple Myeloma
Intervention: Afatinib Dimaleate
Intervention description: Given PO
Intervention MeSH terms: Afatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II MATCH treatment trial identifies the effects of afatinib in patients whose
      cancer has genetic changes called HER2 mutations. Afatinib may stop the growth of cancer
      cells by blocking the HER2 receptor, a protein that may be needed for cell growth.
      Researchers hope to learn if afatinib 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

          -  Patient's tumor must have activating HER2 mutation, as determined via the MATCH Master
             Protocol

               -  Additionally, any in-frame insertions in exon 20 will be considered an activating
                  mutation

          -  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 with known left ventricular dysfunction must have echocardiogram (ECHO) or a
             nuclear study (multiple-gated acquisition [MUGA] or First Pass) within 4 weeks prior
             to registration to treatment and must not have left ventricular ejection fraction
             (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a
             site, the LVEF must be > 50% for the patient to be eligible

               -  NOTE: Pre-treatment LVEF determination in patients without known left ventricular
                  dysfunction is NOT otherwise required.

          -  Patients must have =< grade 1 diarrhea at baseline

          -  Patients must have =< grade 1 renal function as defined below:

               -  Creatinine =< 1.5 x normal institutional limits OR

               -  Measured creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine
                  levels above institutional normal or as calculated by the Cockcroft-Gault
                  equation

                    -  This should be strictly followed and will override the MATCH Master Protocol
                       requirements

        Exclusion Criteria:

          -  Patients must not have known hypersensitivity to afatinib or compounds of similar
             chemical or biologic composition

          -  Patients with a history of interstitial lung disease will be excluded

          -  Patients must not have had prior treatment with any of the following tyrosine kinase
             inhibitors (TKIs), which have known activity against HER2 kinase:

               -  Neratinib

               -  AC-480 (BMS-599626)

               -  AST 1306

               -  Canertinib (CI 1033)

               -  CUDC-101

               -  Lapatinib

               -  TAK285

               -  Afatinib

               -  AEE 788

               -  AZD8931

               -  CP-724714

               -  Dacomitinib

               -  Pelitinib

          -  Patients with non-small cell lung cancer will be excluded