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SU6668 in Treating Patients With Advanced Solid Tumors

2014-08-27 03:56:35 | BioPortfolio

Summary

RATIONALE: SU6668 may stop the growth of solid tumors by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of SU6668 in treating patients who have advanced solid tumors.

Description

OBJECTIVES:

- Determine the optimal biologically effective dose of SU6668 in patients with advanced solid tumors.

- Assess the safety and tolerability of this therapy in these patients.

- Determine the pharmacokinetic profile and interpatient pharmacologic variability of this therapy in these patients.

- Determine the extent, frequency, and duration of any tumor responses in patients treated with this therapy.

- Determine a recommended phase II dose of SU6668 for future clinical studies.

OUTLINE: This is a dose-escalation study.

Patients receive oral SU6668 twice daily on days 1-28. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression of 100% or more.

Cohorts of at least 6 patients receive escalating doses of SU6668 until the optimal biologically effective dose (OBD) is determined. Once the OBD is reached, dose escalation continues until the maximum tolerated dose (MTD) is determined (if possible). The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention

SU6668

Location

University of Texas - MD Anderson Cancer Center
Houston
Texas
United States
77030-4009

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:35-0400

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