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Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks (NCT00003979)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors.
  • Drug: CHS 828
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers

    - Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors.

    - Determine the qualitative and quantitative toxic effects of this regimen in these patients.

    - Determine a safe dose of this regimen for phase II evaluation.

    - Determine the pharmacokinetic profile of this regimen in these patients.

    - Determine any antitumor activity in these patients.

    OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity.

    Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.

    Patients are followed for up to 4 weeks.

    PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.

    28 locations

    31 March, 1999
    09 July, 2012
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