{
"info": {
"nct_id": "NCT00874731",
"official_title": "A Clinical Trial to Assess the Effect of Ridaforolimus (AP23573; MK-8669) on QTc Interval in Patients",
"inclusion_criteria": "* Participant must have metastatic or locally advanced cancer which has failed to respond to standard therapy or no therapy exists.\n* 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.\n* 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.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Participant has had chemotherapy, radiotherapy or biological therapy within the past 4 weeks.\n* Participant is currently receiving other anti-cancer therapy.\n* Participant is currently participating or has participated in a study with an investigation drug or device within the last 30 days.\n* Participant has a primary central nervous system tumor or active brain metastases.\n* Participant has a psychiatric disorder.\n* Participant uses illegal drugs.\n* Participant is pregnant or breastfeeding.\n* Participant is known to be human immunodeficiency virus (HIV) positive.\n* Participant has a known history of Hepatitis B or C.\n* Participant has newly diagnosed diabetes.\n* Participant has an active infection.\n* Participant is unable to swallow capsules.\n* Participant has received a blood transfusion with one week of study entry.\n* Participant has a history of cardiac problems including heart failure, myocardial infarction, unstable angina, congestive heart failure or cardiac arrhythmia.\n* Participant has a known sensitivity to the components of the study drug.\n* Participant has not adequately recovered from any prior surgical procedure.\n* 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.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
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"identified_line": {
"line": "* Participant must have metastatic or locally advanced cancer which has failed to respond to standard therapy or no therapy exists.",
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{
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]
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},
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"expected_value": false
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"exact_snippets": "no therapy exists",
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"requirement": {
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"expected_value": false
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}
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{
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"else_criteria": null
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"expected_value": true
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"exact_snippets": "during the study and for 30 days after the last dose of study drug",
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"else_criteria": null
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"identified_line": {
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"unit": "Years"
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"unit": "Years"
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"value": 4,
"unit": "weeks"
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"unit": "weeks"
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}
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}
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{
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}
}
},
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},
{
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{
"not_criteria": {
"exact_snippets": "Participant does not agree to refrain from ... consumption of grapefruit juice",
"criterion": "consumption of grapefruit juice",
"requirement": {
"requirement_type": "agreement to refrain",
"expected_value": true
}
}
}
]
},
{
"exact_snippets": "for 2 weeks prior to and during the study",
"criterion": "timeframe for refraining",
"requirement": {
"requirement_type": "duration",
"expected_value": "2 weeks prior to and during the study"
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}