Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
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: Taselisib
Intervention description: Given PO
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II MATCH treatment trial identifies the effects of GDC-0032 (taselisib) in
      patients whose cancer has a genetic change called PIK3CA mutation. Taselisib may stop the
      growth of cancer cells by blocking PIK3CA, a protein that may be needed for cell growth.
      Researchers hope to learn if taselisib 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 a 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 with known left ventricular dysfunction must have echocardiogram (ECHO) or
             multigated acquisition scan (MUGA) 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

          -  Patients must have a fasting glucose =< 125 mg/dL

               -  NOTE: Please provide clear documentation that the glucose test was conducted at a
                  fasting state

          -  Patients with prior treatment with an mTOR inhibitor are acceptable. These include,
             but are not limited to: temsirolimus, everolimus, ridaforolimus, sirolimus, CC-223,
             MLN128 (INK128), DS-3078, CC-115, AZD-2014, AZD8055

        Exclusion Criteria:

          -  Patients must not have known hypersensitivity to GDC-0032 (taselisib) or compounds of
             similar chemical or biologic composition

          -  Patients must not have breast cancer

          -  Patients with squamous cell carcinoma of the lung who have PIK3CA mutations who have
             access to AND are eligible for Lung-MAP (S1400) are not eligible

          -  Patients must not have KRAS mutations, and/or PTEN mutation or loss, detected in the
             tumor sample as determined by the MATCH screening assessment. PTEN loss will be
             determined by immunohistochemistry

          -  Patients must not have had prior therapy with a PI3K inhibitor or PI3K/mTOR inhibitor.
             These include, but are not limited to: BEZ235, XL-765 (SAR245409), GDC-0980,
             PF-04691502, PF-05212384 (PKI-587), SF-1126, GSK 2126458, P-7170, BGT-226, LY3023414,
             GDC-0084, DS-7423, BKM-120 (buparlisib), PX-866, XL-147, GDC-0941 (pictilisib),
             VS-5584, BAY-80-6946, ZSTK-474, WX 037, AZD8835, GSK2636771, GS-9820, BYL719, MLN1117
             (INK1117), idelalisib, TGR1202, RP6530, duvelisib (IPI-145), CUDC-907. Prior GDC-0032
             (taselisib) is not allowed

          -  Patients must not have had prior therapy with an Akt inhibitor. These include, but are
             not limited to: MK-2206, GSK690693, AZD5363, triciribine, perifosine, GSK2141795,
             GSK2110183, SR13668, BAY1125976, GDC-0068 (ipatasertib), LY2780301, ARQ092

          -  Patients must not have type 1 or 2 diabetes requiring anti-hyperglycemic medication
             (e.g. metformin, glipizide, insulin)

          -  Patients must not have current dyspnea at rest or require any daily supplemental
             oxygen

          -  Patients must not have history of inflammatory bowel disease (e.g. Crohn's disease or
             ulcerative colitis) or active bowel inflammation (e.g. diverticulitis)