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

Resource links provided by NLM:


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
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
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014