Pharmacokinetics of Ridaforolimus (MK-8669) in Chinese Participants (MK-8669-059)
Condition: Cancer, Advanced
Intervention: ridaforolimus
Intervention description: 4 enteric-coated tablets, each containing 10 mg ridaforolimus, orally (total daily dose: 40 mg)
Intervention MeSH terms: Sirolimus
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Relapsed cancer

Summary:

      Part 1 of the study will assess the pharmacokinetics, safety, and tolerability of
      ridaforolimus (MK-8669) after administration of single and multiple 40 mg doses in Chinese
      participants with advanced cancer. Part 2 of the study is optional; participants can continue
      to receive the study treatment in a weekly regimen of daily oral doses of ridaforolimus 40 mg
      for five consecutive days followed by two days off-treatment.
    

Eligibility criteria:

        Inclusion criteria:

          -  Chinese descent with all 4 biological grandparents born in China and of Chinese
             descent.

          -  Histologically- or cytologically-confirmed metastatic or locally advanced solid tumor
             or lymphoma that has failed to respond to standard therapy, progressed despite
             standard therapy, or for which standard therapy does not exist.

          -  Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance
             Scale.

          -  Female participants must be post-menopausal.

          -  Male participants must agree to use a medically-acceptable method of
             contraception/barrier protection during the study and for 30 days after the last dose
             of study treatment.

          -  Participants must be healthy enough to receive the study treatments (that is, meet
             certain laboratory value parameters).

          -  Life expectancy of >3 months.

        Exclusion criteria:

          -  Chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for
             nitrosoureas, mitomycin C, and monoclonal antibodies) prior to first dose of study
             treatment (Part 1/Day 1) or has not recovered from adverse events due to agents
             administered more than 4 weeks earlier.

          -  Any other concurrent anti-cancer therapy (except luteinizing hormone releasing hormone
             [LHRH] analogs for prostate cancer).

          -  Concurrent treatment with immunosuppressive agents, including corticosteroids, at
             doses greater than those used for replacement therapy.

          -  Clinically significant abnormality on electrocardiogram (ECG) performed at the
             screening visit and/or prior to administration of the initial dose of study treatment.

          -  New York Heart Association (NYHA) Class III or IV congestive heart failure or any
             other significant history of cardiac disease including: myocardial infarction within
             the last 6 months; ventricular arrhythmia or acute congestive heart failure within the
             last 3 months; uncontrolled angina; or uncontrolled hypertension.

          -  Current participation or participation in a study with an investigational compound or
             device within 30 days prior to the first dose of study treatment.

          -  Primary central nervous system tumor, active brain metastases or leptomeningeal
             carcinomatosis.

          -  Regular use (including use of any illicit drugs or had a recent history within the
             last year) of drugs, or alcohol abuse.

          -  Pregnant or breastfeeding, or expecting to conceive within the projected duration of
             the study.

          -  Human Immunodeficiency Virus (HIV)-positive.

          -  Newly diagnosed (within 3 months before the first dose of study drug) or poorly
             controlled Type 1 or 2 diabetes.

          -  Required treatment with medications that are inducers or inhibitors of cytochrome P450
             (CYP3A).

          -  Active infection or use of intravenous (IV) antibiotics, antiviral, or antifungal
             agents within 2 weeks prior to the first dose of the study treatment.

          -  Use of or intention to use herbal teas or herbal remedies (including traditional
             Chinese medicine, St.John's Wort, shark cartilage, etc.) from 2 weeks prior to the
             first dose and throughout the study.

          -  Anticipation of need for immunologic therapy, radiation therapy, surgery, or
             chemotherapy during the study.

          -  Past high-dose chemotherapy with stem cell rescue.

          -  Blood transfusion within one week of study entry.

          -  Inability to swallow capsules and/or documented surgical or anatomical condition that
             will preclude swallowing and absorbing oral medications on an ongoing basis.

          -  Known hypersensitivity to the components of the study treatment or its analogs or
             antibiotics (e.g. clarithromycin, erythromycin, azithromycin).

          -  Intention to consume grapefruit or grapefruit juice for approximately 2 weeks prior to
             first dosing until the completion of the study.

          -  Inadequate recovery from any prior surgical procedure or any major surgical procedure
             within 4 weeks prior to the first dose of study treatment.