A Study of TAK-659 as a Single Agent in Adult East Asian Participants With Non-Hodgkin Lymphoma (NHL)
Condition: Lymphoma, Non-Hodgkin; Lymphoma, Follicular, Marginal Zone
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Intervention: TAK-659
Intervention description: TAK-659 Tablets.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to determine the safety, tolerability, maximum tolerated dose
      (MTD) and/or recommended phase 2 dose (RP2D) of TAK-659 when administered in East Asian
      participants with NHL who do not have an effective standard treatment available and to
      characterize the plasma and urine pharmacokinetic (PK) of TAK-659 in East Asian participants
      with NHL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. To be enrolled to the dose escalation part, participants must have histologically or
             cytologically confirmed diagnosis of NHL for which no effective standard treatment is
             available.

          2. To be enrolled in the expansion part, participants must meet the following criteria:

               1. Must have pathologically confirmed FL (Grade 1, 2, or 3A) or MZL.

               2. Relapsed and/or refractory to >=2 prior lines of chemotherapy based on standard
                  of care that include at least 1 anti-CD20-based regimen, as well as alkylating
                  agents (example cyclophosphamide or bendamustine).

               3. Participants must be ineligible for or refusal to hematopoietic stem cell
                  transplant.

               4. If the participants have relapsed or progressed after achieving a response
                  (defined as CR or PR), documented, investigator-assessed relapse or progression
                  after the last treatment is required.

          3. Measurable disease per IWG 2007 criteria.

          4. Eastern Cooperative Oncology Group performance status score of 0 or 1.

          5. Life expectancy of longer than 3 months.

          6. Adequate organ function, including the following:

               1. Bone marrow reserve: absolute neutrophil count >=1,000 per cubic millimeter
                  (/mm^3), platelet count >=75,000/mm^3 (>=50,000/mm^3 for participants with bone
                  marrow involvement), and hemoglobin >=8 gram per deciliter (g/dL) (red blood cell
                  [RBC] and platelet transfusion allowed >=14 days before assessment).

               2. Hepatic function: total bilirubin less than or equal to (<=) 1.5*the upper limit
                  of the normal range (ULN); alanine aminotransferase and aspartate
                  aminotransferase <=2.5*ULN.

               3. Renal function: creatinine clearance >=60 milliliter per minute (mL/min) either
                  as estimated by the Cockcroft-Gault equation.

        Exclusion Criteria:

          1. Central nervous system (CNS) lymphoma; active brain or leptomeningeal metastases as
             indicated by positive cytology from lumbar puncture or computed tomography
             (CT)/magnetic resonance imaging (MRI) by local assessment.

          2. Systemic anticancer treatment (including investigational agents) less than 3 weeks
             before the first dose of study treatment (<=4 weeks for antibody-based therapy
             including unconjugated antibody, antibody-drug conjugate, and bi-specific T-cell
             engager agent; <=8 weeks for cell-based therapy or anti-tumor vaccine).

          3. Radiotherapy less than (<) 3 weeks before the first dose of study treatment. If prior
             radiotherapy occurred <4 to 6 weeks before the study start, as radiated lesions cannot
             be reliably assessed by fluoro-2-deoxy-D-glucose (FDG)-positron emission tomography
             (PET), nonradiated target lesions are required for eligibility.

          4. Prior autologous stem cell transplant (ASCT) within 6 months or prior ASCT at any time
             without full hematopoietic recovery before Cycle 1 Day 1, or allogeneic stem cell
             transplant at any time.

          5. Any clinically significant comorbidities, such as uncontrolled pulmonary disease
             (example, severe chronic obstructive pulmonary disease with hypoxemia, interstitial
             lung disease, radiation induced lung injury), known impaired cardiac function or
             clinically significant cardiac disease, active CNS disease, or any other condition
             that could, in the opinion of the investigator, compromise the participant's safety
             and participation in the study per protocol.

          6. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral
             absorption or tolerance of TAK-659.

          7. Use or consumption of any of the following substances:

        Received medications, supplements, or food/beverages that are P-glycoprotein (P-gp)
        inhibitors or inducers or strong cytochrome P450 (CYP) 3A inhibitors or inducers within a
        certain time frame prior to the first dose of study drug. Depending on the substance, the
        washout period for P-gp inhibitors or inducers or strong CYP3A inhibitors or inducers will
        be either 7 days or 5 times the half-life (half-life is related to the time required for
        elimination from the body). The washout period for grapefruit containing food or beverages
        is 5 days.