A Study to Evaluate the Effect of MK-8669 (Ridaforolimus) on QTc Interval in Participants With Advanced Cancer (MK-8669-037)
Condition: Metastatic or Locally Advanced Cancer
MeSH terms: Neoplasms
Intervention: Ridaforolimus 100 mg; Ridaforolimus 40 mg; Placebo
Intervention description: Part 1: A single oral dose of 100 mg ridaforolimus (10 x 10 mg tablets) was given on Day 2.; Part 2 (optional): Ridaforolimus 40 mg (4 x 10 mg tablets) was received on a regimen of daily oral doses for 5 consecutive days followed by 2 days off-drug.; Part 1: A single oral dose of placebo (10 x placebo tablets) was given on Day 1.
Intervention MeSH terms: Sirolimus
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Participant)
Masking description: Participants will be blinded to treatment during Part 1 only.
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the potential for ridaforolimus to prolong the QTc interval (an effect on the
      electrical activity of the heart) in participants with advanced cancer. This study will be
      done in 2 parts. Part 1 (Pt 1) will evaluate the effect of a single 100 mg dose of
      ridaforolimus on QT interval in participants with advanced cancer. Fridericias's correction
      (QTcF) will be used. In Part 2 (Pt 2), participants will receive ridaforolimus at the current
      therapeutic dose (40 mg x 5 days).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have metastatic or locally advanced cancer which has failed to
             respond to standard therapy or no therapy exists.

          -  If the participant is a female, she must be postmenopausal or if she is of
             childbearing potential she must have blood pregnancy tests during the study and be
             willing to use 2 methods of contraception.

          -  If the participant is male and has female partners of child-bearing potential, he must
             agree to use a medically acceptable method of contraception during the study and for
             30 days after the last dose of study drug.

        Exclusion Criteria:

          -  Participant has had chemotherapy, radiotherapy or biological therapy within the past 4
             weeks.

          -  Participant is currently receiving other anti-cancer therapy.

          -  Participant is currently participating or has participated in a study with an
             investigation drug or device within the last 30 days.

          -  Participant has a primary central nervous system tumor or active brain metastases.

          -  Participant has a psychiatric disorder.

          -  Participant uses illegal drugs.

          -  Participant is pregnant or breastfeeding.

          -  Participant is known to be human immunodeficiency virus (HIV) positive.

          -  Participant has a known history of Hepatitis B or C.

          -  Participant has newly diagnosed diabetes.

          -  Participant has an active infection.

          -  Participant is unable to swallow capsules.

          -  Participant has received a blood transfusion with one week of study entry.

          -  Participant has a history of cardiac problems including heart failure, myocardial
             infarction, unstable angina, congestive heart failure or cardiac arrhythmia.

          -  Participant has a known sensitivity to the components of the study drug.

          -  Participant has not adequately recovered from any prior surgical procedure.

          -  Participant does not agree to refrain from use of herbal remedies and consumption of
             grapefruit juice for 2 weeks prior to and during the study.