Testing AZD4547 as a Potential Targeted Treatment in Cancers With FGFR Genetic Changes (MATCH-Subprotocol W)
Condition: Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Plasma Cell Myeloma
MeSH terms: Lymphoma; Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: FGFR Inhibitor AZD4547
Intervention description: Given PO
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FGFR; AZD4547; NCI-MATCH

Summary:

      This phase II MATCH treatment trial identifies the effects of AZD4547 in patients whose
      cancer has genetic changes called FGFR gene alterations. AZD4547 may stop the growth of
      cancer cells by blocking FGFR proteins which may be needed for cell growth. Researchers hope
      to learn if AZD4547 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 FGFR 1-3 mutation or translocation as determined by the MATCH
             screening assessment

          -  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 must have an echocardiogram (ECHO) or a nuclear study (multigated acquisition
             scan [MUGA] or First Pass) within 4 weeks prior to registration to treatment and must
             not have a 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

          -  Patients must have a pre-study eye exam by an ophthalmologist. Patients with current
             evidence of corneal or retinal disorder/keratopathy are excluded

        Exclusion Criteria:

          -  Patients must not have known hypersensitivity to AZD4547 or compounds of similar
             chemical or biologic composition

          -  Patients must not have received prior FGFR specific inhibitors (e.g. BGJ398,
             erdafitinib, BAY1163877, LY2874455). Prior non-selective FGFR inhibitor treatment
             (e.g. pazopanib, dovitinib, ponatinib, brivanib, lucitanib, lenvatinib) will be
             allowed

          -  Patients must not have any history of or current evidence of renal or endocrine
             alterations of calcium/phosphate homeostasis, or history of or current evidence of
             extensive tissue calcification (by evaluation of the clinician), including but not
             limited to, the soft tissue, kidneys, intestine, myocardium and lung with the
             exception of calcified lymph nodes and asymptomatic vascular calcification per
             investigators' judgment

          -  Patients must not be currently using medications that can elevate serum phosphorous
             and/or calcium levels

               -  Medications that increase serum calcium should be avoided. Over the counter
                  calcium supplements, antacids that contain calcium (Tums) and vitamin D
                  supplements (cholecalciferol and ergocalciferol) should be avoided. Prescription
                  medications including lithium, hydrochlorothiazide and chlorthalidone must be
                  used with caution

               -  Medications that increase serum phosphate should be avoided. Over the counter
                  laxatives that contain phosphate such as Fleets Oral or Fleets enema and Miralax
                  should be avoided