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A Study to Assess the Pharmacokinetics of Ridaforolimus in Chinese Patients

Phase 1
18 Years
75 Years
Not Enrolling
Cancer, Advanced

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Trial Information

A Study to Assess the Pharmacokinetics of Ridaforolimus in Chinese Patients

Inclusion Criteria

Inclusion criteria:

- Chinese descent with all 4 biological grandparents born in China and of Chinese

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants experiencing clinical and laboratory adverse events (AEs)

Outcome Time Frame:

From first dose up to 30 days after last dose (up to 22 weeks)

Safety Issue:



China: Ethics Committee

Study ID:




Start Date:

July 2011

Completion Date:

April 2012

Related Keywords:

  • Cancer, Advanced
  • Relapsed cancer