A Study to Evaluate the Effect of MK-8669 (Ridaforolimus) on QTc Interval in Participants With Advanced Cancer (MK-8669-037)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Metastatic or Locally Advanced Cancer

Treatments: Drug: Ridaforolimus 100 mg; Drug: Ridaforolimus 40 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00874731

8669-037

MK-8669-037 (Other Identifier)

2009_569 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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23 participants in 1 patient group

Pt 1. Placebo/Ridaforolimus 100 mg; Pt 2. Ridaforolimus 40 mg

Experimental group

Description:

[Pt 1, Day 1]: Participants received a single dose of placebo (10 oral tablets) on Day 1 of Part 1. [Pt 1, Day 2]: Following completion of Part 1 / Day 1, participants received a single dose of ridaforolimus 100 mg (10 x 10 mg oral tablets) on Day 2 of Part 1. Following completion of Part 1 / Day 2, participants entered a washout period of ≥5 days before the first dose Part 2. [Pt 2]: Following completion of Part 1, participants received ridaforolimus 40 mg (4 x 10 mg oral tablets) given once daily (QD) for 5 consecutive days followed by 2 days off-drug.

Treatment:

Drug: Placebo

Drug: Ridaforolimus 40 mg

Drug: Ridaforolimus 100 mg