Clinical trial · Interventional
Pharmacokinetics of Ridaforolimus (MK-8669) in Chinese Participants (MK-8669-059)
A Study to Assess the Pharmacokinetics of Ridaforolimus in Chinese Patients
NCT01380184CI-TRIAL-00038257completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Part 1 of the study will assess the pharmacokinetics, safety, and tolerability of ridaforolimus (MK-8669) 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 treatment in a weekly regimen of daily oral doses of ridaforolimus 40 mg for five consecutive days followed by two days off-treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Advanced | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ridaforolimus | Drug | Ridaforolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ridaforolimus 40 mg
- description
- In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
- interventionNames
- Drug: ridaforolimus
Primary outcomes (7)
- measure
- Lag Time (Tlag) of Ridaforolimus: Day 1
- timeFrame
- Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 is 19 days
- description
- Tlag is the time taken for ridaforolimus to appear in systemic circulation following oral administration. The median and full range (minimum, maximum) for Tlag after a single dose of ridafolorlimus are presented.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria: * 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 treatment. * Participants must be healthy enough to receive the study treatments (that is, meet certain laboratory value parameters). * Life expectancy of \>3 months. Exclusion criteria: * Chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas, mitomycin C, and monoclonal antibodies) prior to first dose of study treatment (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 treatment. * 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 treatment. * 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 treatment. * 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 treatment 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 treatment.
References
Publications (1)
- RESULTLiu L, Zhang W, Li W, Lv F, Xia Z, Zhang S, Liu W, Zandvliet AS, Waajen S, Zhang LX, Yan L, Li J. A phase I study of ridaforolimus in adult Chinese patients with advanced solid tumors. J Hematol Oncol. 2013 Jul 8;6:48. doi: 10.1186/1756-8722-6-48. PMID 23829943