Pharmacokinetics of Ridaforolimus in Chinese Participants (MK-8669-059)
This study has been completed.
Information provided by (Responsible Party):
First received: June 22, 2011
Last updated: May 28, 2013
Last verified: May 2013
Part 1 of the study will assess the pharmacokinetics, safety, and tolerability of ridaforolimus after administration of single and multiple 40 mg doses in Chinese participants with advanced cancer. Part 2 of the study is optional; participants can continue to receive the study drug in a weekly regimen of daily oral doses of ridaforolimus 40 mg for 5 consecutive days followed by 2 days off-drug.
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Study to Assess the Pharmacokinetics of Ridaforolimus in Chinese Patients
Primary Outcome Measures:
- Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: From first dose up to 30 days after last dose (up to 22 weeks) ] [ Designated as safety issue: Yes ]
Other Outcome Measures:
- Lag Time (Tlag) [ Time Frame: Cycle 1 Day 1 ] [ Designated as safety issue: No ]
- Area under the curve (AUC)[0-infinity] of Ridaforolimus [ Time Frame: Cycle 1 Day 1 ] [ Designated as safety issue: No ]
- AUC [0-24 Hours] of Ridaforolimus [ Time Frame: Cycle 1 Day 1 and Day 19 ] [ Designated as safety issue: No ]
- Maximum Concentration (Cmax) of Ridaforolimus [ Time Frame: Cycle 1 Day 1 and Day 19 ] [ Designated as safety issue: No ]
- Concentration at 24 Hours (C[24 hr]) of Ridaforolimus [ Time Frame: Cycle 1 Day 1 and Day 19 ] [ Designated as safety issue: No ]
- Time to Maximum Concentration (Tmax) of Ridaforolimus [ Time Frame: Cycle 1 Day 1 and Day 19 ] [ Designated as safety issue: No ]
- Apparent Terminal Half-life (t1/2) of Ridaforolimus [ Time Frame: Cycle 1 Day 1 and Day 19 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2011 (Final data collection date for primary outcome measure)
Experimental: Ridaforolimus 40 mg
4 enteric coated tablets (ECT), each containing 10 mg ridaforolimus, orally (total 40 mg), on Day 1 and Days 8-12 of Cycle 1, and then once daily for 5 consecutive days in all subsequent cycles
- ridaforolimus was also known as deforolimus until May 2009
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Chinese descent with all 4 biological grandparents born in China and of Chinese descent.
- Histologically- or cytologically-confirmed metastatic or locally advanced solid tumor or lymphoma that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
- Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Female participants must be post-menopausal.
- Male participants must agree to use a medically-acceptable method of contraception/barrier protection during the study and for 30 days after the last dose of study drug.
- Participants must be healthy enough to receive the study drugs (that is, meet certain laboratory value parameters).
- Life expectancy of >3 months.
- Chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas, mitomycin C, and monoclonal antibodies) prior to first dose of study drug (Part 1/Day 1) or has not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Any other concurrent anti-cancer therapy (except luteinizing hormone releasing hormone [LHRH] analogs for prostate cancer).
- Concurrent treatment with immunosuppressive agents, including corticosteroids, at doses greater than those used for replacement therapy.
- Clinically significant abnormality on electrocardiogram (ECG) performed at the screening visit and/or prior to administration of the initial dose of study drug.
- New York Heart Association (NYHA) Class III or IV congestive heart failure or any other significant history of cardiac disease including: myocardial infarction within the last 6 months; ventricular arrhythmia or acute congestive heart failure within the last 3 months; uncontrolled angina; or uncontrolled hypertension.
- Current participation or participation in a study with an investigational compound or device within 30 days prior to the first dose of study drug.
- Primary central nervous system tumor, active brain metastases or leptomeningeal carcinomatosis.
- Regular use (including use of any illicit drugs or had a recent history within the last year) of drugs, or alcohol abuse.
- Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study.
- Human Immunodeficiency Virus (HIV)-positive.
- Newly diagnosed (within 3 months before the first dose of study drug) or poorly controlled Type 1 or 2 diabetes.
- Required treatment with medications that are inducers or inhibitors of cytochrome P450 (CYP3A).
- Active infection or use of intravenous (IV) antibiotics, antiviral, or antifungal agents within 2 weeks prior to the first dose of the study drug.
- Use of or intention to use herbal teas or herbal remedies (including traditional Chinese medicine, St. John's Wort, shark cartilage, etc.) from 2 weeks prior to the first dose and throughout the study.
- Anticipation of need for immunologic therapy, radiation therapy, surgery, or chemotherapy during the study.
- Past high-dose chemotherapy with stem cell rescue.
- Blood transfusion within one week of study entry.
- Inability to swallow capsules and/or documented surgical or anatomical condition that will preclude swallowing and absorbing oral medications on an ongoing basis.
- Known hypersensitivity to the components of the study drug or its analogs or antibiotics (e.g., clarithromycin, erythromycin, azithromycin).
- Intention to consume grapefruit or grapefruit juice for approximately 2 weeks prior to first dosing until the completion of the study.
- Inadequate recovery from any prior surgical procedure or any major surgical procedure within 4 weeks prior to the first dose of study drug.
No Contacts or Locations Provided
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 22, 2011
||May 28, 2013
||China: Ethics Committee
Keywords provided by Merck:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 18, 2013
Physiological Effects of Drugs