Pharmacokinetics of Ridaforolimus (MK-8669) in Chinese Participants (MK-8669-059)

NCT ID: NCT01380184

Last Updated: 2019-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-05
• Study Completion Date: 2012-04-05

Brief Summary

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

Cancer, Advanced

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ridaforolimus 40 mg

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.

Group Type: EXPERIMENTAL

ridaforolimus

Intervention Type: DRUG

4 enteric-coated tablets, each containing 10 mg ridaforolimus, orally (total daily dose: 40 mg)

Interventions

ridaforolimus

4 enteric-coated tablets, each containing 10 mg ridaforolimus, orally (total daily dose: 40 mg)

Intervention Type: DRUG

Other Intervention Names

MK-8669; AP23573; ridaforolimus was also known as deforolimus until May 2009

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Liu 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.

Reference Type: RESULT

PMID: 23829943 (View on PubMed)

Other Identifiers

MK-8669-059

Identifier Type: OTHER

Identifier Source: secondary_id

8669-059

Identifier Type: -

Identifier Source: org_study_id