SU006668 in Treating Patients With Advanced Solid Tumors
Recruitment status was: Active, not recruiting
RATIONALE: Drugs such as SU006668 may stop the growth of solid tumors by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of SU006668 in treating patients who have advanced solid tumors.
|Breast Cancer Colorectal Cancer Gastric Cancer Kidney Cancer Lung Cancer Multiple Myeloma and Plasma Cell Neoplasm Pancreatic Cancer Prostate Cancer||Drug: orantinib||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study Of SU006668 Via Twice Daily Oral Administration Under Fed Conditions In Patients With Advanced Malignancies|
OBJECTIVES: I. Determine the maximum tolerated dose of SU006668 in patients with advanced solid tumors. II. Determine the pharmacokinetics of this drug in these patients. III. Determine the objective response of patients treated with this drug. IV. Determine the toxic effects of this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients receive oral SU006668 twice daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 6 to 12 patients receive escalating doses of SU006668 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 or 4 of 12 patients experience dose-limiting toxicity. Patients are followed at 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024063
|Study Chair:||Lee S. Rosen, MD||Jonsson Comprehensive Cancer Center|