Study of Safety and Pharmacokinetics of MK-8242 in Participants With Advanced Solid Tumors (P07650)
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: MK-8242
Intervention description: 10 mg, 100 mg and 150 mg capsules
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being done to evaluate the safety and pharmacokinetic profile of MK-8242 and
      its active metabolite (M16) in participants with advanced solid tumors. In Part 1 of the
      study, the study drug dose will be escalated to determine the maximum tolerated dose (MTD).
      In Part 2 of the study, the MTD will be confirmed and the recommended Phase 2 dose (RPTD)
      established; the effect of MK-8242 on liposarcoma and other tumor types will also be
      evaluated.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically confirmed advanced solid tumor for which there are no effective
             standard therapy options

          -  Willing to provide tumor tissue for p53 wild type gene analysis

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

          -  Adequate organ function

          -  Female participants and male participants and their partners who are of childbearing
             potential must agree to abstain from sexual intercourse or to use an acceptable method
             of contraception during the study and for 90 days following the last dose of study
             drug

          -  At least one measurable lesion

          -  In Part 2, participants with liposarcoma must have a confirmed well-differentiated or
             de-differentiated histology

        Exclusion criteria:

          -  Known treated or untreated leptomeningeal metastases, or metastatic central nervous
             system disease

          -  History of recent myocardial infarction (within the past year); or with unstable or
             uncontrolled angina, New York Heart Association (NYHA) Class III or IV congestive
             heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia
             or clinically significant electrocardiogram (ECG) abnormality

          -  Uncontrolled active infection on optimal systemic treatment

          -  Clinically significant hepatitis or hepatitis C antibody positive, hepatitis B surface
             antigen positive, or human immunodeficiency virus (HIV) seropositive

          -  Persistent, unresolved common terminology criteria for adverse events (CTCAE v4.0)
             ≥Grade 2 drug-related toxicity associated with previous treatment except for alopecia

          -  Radiation therapy or other loco-regional therapy within 2 weeks prior to study

          -  Use of moderate and strong cytochrome P450 inhibitors or inducers within 1 week prior
             to study

          -  Chemotherapy or any investigational drug(s) within 4 weeks prior to study

          -  Known hypersensitivity to MK-8242 or its components

          -  Nursing, pregnant, or intention to become pregnant during the study

          -  Initiating bisphosphonate therapy or adjusting the bisphosphonate dose or regimen
             within 30 days of Cycle 1 Day 1