A Study of the Safety, Tolerability, and Efficacy of MK-8353 in Participants With Advanced Solid Tumors (MK-8353-001)
Condition: Tumor, Solid
Intervention: MK-8353
Intervention description: Administered orally twice daily for 28 days for each cycle
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study of the safety, tolerability, and efficacy of MK-8353 (formerly SCH 900353) given
      as single agent oral therapy for participants with advanced solid tumors will be done into
      two parts. In Part 1a, there will be a dose escalation to find the preliminary maximum
      tolerated dose (MTD), and in Part 1b, dose confirmation to find out the recommended Phase 2
      dose (RPTD) that will be used in Part 2 of the study. In Part 2 of the study, participants
      with certain types of metastatic melanoma or metastatic colorectal cancer will be treated to
      see if MK-8353 is effective as single agent therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically/histologically confirmed solid tumor (metastatic or locally advanced
             disease) that has failed to respond to standard therapy, progressed despite standard
             therapy, or for which standard therapy does not exist.

          -  Participants of childbearing potential must have negative pregnancy test; females and
             males must agree to use effective contraception during the course of the trial and for
             90 days after stopping study drug.

          -  For Part 1b and Part 2, participant with metastatic melanoma or metastatic colorectal
             cancer with at least one measurable lesion

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with a life
             expectancy of ≥3 months.

          -  Adequate organ function.

        Exclusion Criteria:

          -  Unstable or progressing central nervous system (CNS) metastasis unless asymptomatic
             for 3 months, with no need for steroids or antiseizure medications.

          -  Active gastrointestinal disease or a disorder or a history of surgery that
             significantly alters gastrointestinal motility or absorption.

          -  Has not recovered from previous therapy and had any chemotherapy, biologic, or
             hormonal therapy within 4 weeks of study enrollment.

          -  Radiation therapy (except palliative radiation to bone lesions) within 4 weeks of
             study enrollment.

          -  More than 3 prior regimens of chemotherapy, biologic therapy, hormonal therapy, or
             investigational drugs not including adjuvant or neoadjuvant treatments.

          -  Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major
             systemic diseases.

          -  Mean QTcF interval (interval on the electrocardiogram corrected for heart rate using
             Fridericia's correction) > 450 msec at baseline.

          -  Known Human Immunodeficiency Virus (HIV) infection, hepatitis infection, or
             tuberculosis infection.

          -  Current participation in any other interventional clinical study.

          -  History of significant eye disease, including glaucoma, retinopathy, or retinal vein
             occlusion.