A Study to Assess the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics (PK) of TAK-931 in Participants With Advanced Solid Tumors
Condition: Neoplasms, Advanced Solid
Intervention: TAK-931 PIC; TAK-931 Tablet; Esomeprazole
Intervention description: TAK-931 PICs.; TAK-931 Tablets.; Esomeprazole Tablets.
Intervention MeSH terms: Esomeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to estimate the relative bioavailability of TAK-931 tablets in
      reference to powder-in capsule (PIC) and to assess the effect of food and esomeprazole on the
      pharmacokinetics (PK) of TAK-931 as a tablet.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult participants with histologically or cytologically confirmed metastatic or
             locally advanced or metastatic solid tumors for whom there is no available standard
             treatment with proven survival benefit, this therapy is not indicated, or it is
             refused by the participant. Based on the nonclinical data, the following indications
             may have a higher probability of clinical benefit: high-grade serous ovarian cancer,
             uterine carcinosarcoma, squamous esophageal cancer, squamous non-small cell lung
             carcinoma (NSCLC), rectal adenocarcinoma, and in general tumors with known tumor
             protein 53 (TP53) gene mutations. For any of these preferred indications, participants
             should have exhausted standard therapeutic options with a proven survival benefit.

          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

          3. Recovered to Grade 1 or baseline from all toxic effects of previous therapy (except
             alopecia or neuropathy).

          4. Suitable venous access for the study-required blood sampling including PK and
             pharmacodynamic sampling.

          5. Must have a radiographically or clinically evaluable tumor, but measurable disease as
             defined by RECIST v1.1 is not required for participation in this study.

        Exclusion Criteria:

          1. Participants who require continuous use of proton pump inhibitors (PPIs) or
             histamine-2 (H2) receptor antagonists and participants who are taking PPIs within 5
             days before the first dose of study drug.

          2. Treatment with clinically significant enzyme inducers, such as phenytoin,
             carbamazepine, enzalutamide, mitotane, ritonavir, rifampin, or St John's wort within
             14 days before the first dose of study drug.

          3. With treated brain metastases are eligible if there is no evidence of progression for
             at least 4 weeks after central nervous system-directed treatment, as ascertained by
             clinical examination and brain imaging (magnetic resonance imaging [MRI] or CT) during
             the screening period.

          4. Part 2 only: known hypersensitivity to PPIs (example, angioedema or anaphylaxis have
             occurred).

          5. Part 2 only: not being able or willing to take one high fat breakfast as indicated in
             the protocol.