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Investigator(s):
Phillip A. Dennis, M.D., Ph.D. Principal Investigator Phone: 301-496-0929 pdennis@nih.gov
Referral Contact(s):
Hyejeong Root, R.N., M.S.N. Research Nurse Phone: 301-402-0998 Fax: 301-480-2590 roothy@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed solid malignancy that is refractory to standard therapy
• Adequate bone marrow, liver, and kidney function defined as neutrophil count ≥ 1500, platelet count ≥ 100,000, total bilirubin < 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN, and creatinine ≤ 1.5 x ULN
• Women of childbearing potential must have a negative pregnancy test; patients must agree to discontinue oral contraceptives and use barrier method contraception for the duration of the study
• Patients with brain metastasis must have undergone evaluation and appropriate counseling and treatment by radiation oncology
• Patients are ineligible if they are on the following CYP3A4 inhibitors and cannot replace these medications with an equivalent agent for the period of study: amiodarone, quinidine, pimozide, midazolam, triazolam, dihydroergotamine, ergonovine, ergotamine, methylergonovine, lovastatin, simvastatin, atorvastatin, rifampin, rifabutin, felodipine, nifedipine, sildenafil, or St. John’s wort

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Study Outline:

This trial is a phase I dose escalation study designed to determine the maximally tolerated dose of nelfinavir, an FDA approved medication with widespread human use in human immunodeficiency virus infection.

• Patients will be enrolled in cohorts of 3 to 6 patients, with a maximum enrollment of 45 patients
• The first cohort of patients will receive nelfinavir 1250 mg orally twice a day, the dose that is approved for use and well-tolerated in HIV infected patients
• The nelfinavir dose is escalated provided that less than one out of three patients in the cohort experiences dose limiting toxicity
• The maximum tolerated dose will be the dose level at which one out of six patients experiences dose limiting toxicity
• Pharmacokinetic studies using a midazolam probe will be performed at baseline and again at Day 20 of the first cycle
• Each treatment cycle is 21 days
• Restaging is performed every two cycles
• Patients may continue on nelfinavir as long as they are not experiencing dose-limiting toxicity or progression of their cancer
• Tumor biopsies may be performed, but are not required for eligibility

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/3/09
Updated: 10/7/09