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
weeks
- 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