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A Clinical Trial to Assess the Effect of Deforolimus (AP23573; MK-8669) on QTc Interval in Patients (Protocol 037)

Phase 1
18 Years
Not Enrolling
Metastatic or Locally Advanced Cancer.

Thank you

Trial Information

A Clinical Trial to Assess the Effect of Deforolimus (AP23573; MK-8669) on QTc Interval in Patients (Protocol 037)

Inclusion Criteria:

- Patient must have metastatic or locally advanced cancer which has failed to respond
to standard therapy or no therapy exists

- If the patient 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 patient 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:

- Patient has had chemotherapy, radiotherapy or biological therapy within the past 4

- Patient is currently receiving other anti-cancer therapy

- Patient is currently participating or has participated in a study with an
investigation drug or device within the last 30 days

- Patient has a primary central nervous system tumor or active brain metastases

- Patient has a psychiatric disorder

- Patient uses illegal drugs

- Patient is pregnant or breastfeeding

- Patient is known to be human immunodeficiency virus (HIV) positive

- Patient has a known history of Hepatitis B or C

- Patient has newly diagnosed diabetes

- Patient has an active infection

- Patient is unable to swallow capsules

- Patient has received a blood transfusion with one week of study entry

- Patient has a history of cardiac problems including heart failure, myocardial
infarction, unstable angina, congestive heart failure or cardiac arrythmia

- Patient has a known sensitivity to the components of the study drug

- Patient has not adequately recovered from any prior surgical procedure

- Patient does not agree to refrain from use of herbal remedies and consumption of
grapefruit juice for 2 weeks prior to and during the study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Mean change from Baseline to 0.5 hours in Fridericia's Correction to QT interval (QTcF) after single oral 100 mg dose of ridaforolimus versus placebo

Outcome Time Frame:

Baseline and Hour 0.5

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

April 2010

Related Keywords:

  • Metastatic or Locally Advanced Cancer.
  • Neoplasms