Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer
Condition: Metastatic Solid Tumors
Intervention: TAK-117
Intervention description: oral administration of TAK-117, daily and intermittent schedules.
Intervention MeSH terms: Serabelisib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: INK1117; PIK3CA; KINASE; TUMOR; CANCER; Locally advanced or metastatic solid tumors; not eligible for standard of care therapy

Summary:

      The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal
      biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of TAK-117 when
      administered orally in subjects with advanced solid malignancies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects have had their PIK3CA gene mutation status assessed prior to enrolling into
             the study

          -  Subjects must have documented disease progression prior to enrolling into the study

          -  locally advanced or metastatic solid tumors with the exception of primary brain tumor,
             and have failed or are not eligible for standard of care therapy.

          -  Age greater than or equal to (>=) 18 years, including males and females;

          -  Eastern cooperative oncology group (ECOG) performance status (PS) 0-1;

          -  Adequate organ function;

          -  Male subjects must be surgically sterile or must agree to use physician-approved
             contraception during the study and for 30 days following the last study drug
             administration;

          -  Ability to swallow oral medications;

          -  Ability to understand and willingness to sign informed consent prior to initiation of
             any study procedures;

          -  For women of child-bearing potential, negative serum pregnancy test within 14 days
             prior to the first study drug administration and use of physician-approved method of
             birth control from 30 days prior to the first study drug administration to 30 days
             following the last study drug administration

        Exclusion Criteria:

          -  Diagnosis of primary brain tumor; untreated brain metastasis or history of
             leptomeningeal disease or spinal cord compression;

          -  Received prior cancer or other investigational therapy within 2 weeks prior to the
             first administration of study drug;

          -  Have received a systemic corticosteroid within one week prior to the first
             administration of study drug;

          -  Clinically significant cardiac disease;

          -  Myocardial infarction or unstable angina within 6 months prior to the first
             administration of study drug;

          -  Malabsorption ;

          -  Poorly controlled diabetes mellitus;

          -  Pregnancy (positive serum or urine pregnancy test) or breast feeding;

          -  Untreated brain metastasis or history of leptomeningeal disease or spinal cord
             compression;

          -  Failed to recover from the reversible effects of prior anticancer therapies;

          -  Have received a selective phosphoinositide-3-kinase alpha isoform (PI3K-alpha)
             inhibitor

          -  Other clinically significant co-morbidities, such as uncontrolled pulmonary disease,
             active central nervous system (CNS) disease, active infection, or any other condition
             that could compromise the subject's participation in the study

          -  Known human immunodeficiency virus (HIV) infection

          -  Have a secondary malignancy within the last 3 years prior to first dose of study drug,
             excluding treated non-melanoma skin cancer, carcinoma in situ, or locally-treated
             prostate cancer