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Phase I Study of R031-7453, a Novell Cell Cycle Inhibitor, Administered as Escalating Oral Doses in Adults With Solid Tumors: 4-Day Schedule (NCT00003755)

National Cancer Institute (NCI)
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 Ro 31-7453 in treating patients who have locally advanced or metastatic solid tumor.
  • Drug: MKC-1
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    OBJECTIVES: I. Determine the maximum tolerated dose of Ro 31-7453 in patients with solid tumors. II. Determine the toxicity of Ro 31-7453 in this patient population. III. Evaluate the pharmacokinetics and major metabolites of Ro 31-7453 in these patients. IV. Assess any antitumor activity of Ro 31-7453 in these patients.

    OUTLINE: This is a dose escalation study. Patients are treated on one of two treatment arms. In the first stage, cohorts of 1 patient each on arm I receive oral Ro 31-7453 twice daily on days 1-4, and cohorts of 1 patient each on arm II receive oral Ro 31-7453 once daily on days 1-4 at two dose levels higher than for arm I. Dose escalation ceases for each arm with the first instance of dose limiting toxicity (DLT). Two additional patients are entered at the stopping dose for each arm. If no further DLT occurs, the study proceeds to the second stage. In the second stage, dose escalation continues in increments of one dose level for each dosing schedule (arms I and II). Cohorts of 3-6 patients receive escalating doses of Ro 31-7453 in the absence of DLT. If 2 of 6 patients experience DLT at a dose level, escalation ceases and the maximum tolerated dose is defined as the previous dose level. Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. After completion of the 8 courses, patients may continue treatment until disease progression at the discretion of the investigator and the study sponsor. Patients are followed at 4 weeks.

    PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study over 18 months.

    1 locations

    United States (1)
    • Memorial Sloan-Kettering Cancer Center
      Not specified
      New York, New York, United States, 10021
    30 September, 1998
    23 June, 2013
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