Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01380184
First received: June 22, 2011
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cancer, Advanced
Drug: ridaforolimus
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Assess the Pharmacokinetics of Ridaforolimus in Chinese Patients

Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Enrollment: 15
Study Start Date: July 2011
Study Completion Date: April 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ridaforolimus 40 mg Drug: ridaforolimus
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
Other Names:
  • MK-8669
  • AP23573
  • ridaforolimus was also known as deforolimus until May 2009

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 drug.

- Participants must be healthy enough to receive the study drugs (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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01380184     History of Changes
Other Study ID Numbers: 8669-059
Study First Received: June 22, 2011
Last Updated: March 7, 2014
Health Authority: China: Ethics Committee

Keywords provided by Merck Sharp & Dohme Corp.:
Relapsed cancer

Additional relevant MeSH terms:
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014