Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Pharmacokinetic and Phase I Study of Sorafenib (BAY 43-9006, NSC 724772, IND 69896) for Solid Tumors and Hematologic Malignancies in Patients With Hepatic or Renal Dysfunction
This phase I trial is studying the side effects and best dose of sorafenib in treating patients with metastatic or unresectable solid tumors, multiple myeloma, or non-Hodgkin's lymphoma with or without impaired liver or kidney function. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Sorafenib may have different effects in patients who have changes in their liver or kidney function
PRIMARY OBJECTIVES:
I. To characterize the pharmacokinetics of BAY 43-9006 in patients with hepatic or renal
dysfunction (part 1 of the study).
II. To determine a tolerable starting dose of BAY 43-9006 in patients with varying degrees
of hepatic or renal dysfunction (part 2 of the study).
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 9
treatment cohorts according to hepatic or renal function.
Patients receive oral sorafenib once on day 1 and then once daily, twice daily, or every
other day beginning on day 8 and continuing for 3 months. Patients are re-evaluated at 3
months. Patients with responding disease may continue study treatment in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients (per treatment cohort) receive escalating doses of sorafenib until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6
patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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