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TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)

2014-08-27 03:54:37 | BioPortfolio

Summary

RATIONALE: TAC-101 may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: This phase I/II trial is studying the side effects and best dose of TAC-101 and to see how well it works in treating patients with advanced hepatocellular carcinoma (liver cancer).

Description

OBJECTIVES:

Phase I

- Primary

- Determine the maximum tolerated dose (MTD) of TAC-101 in patients with advanced hepatocellular carcinoma.

- Determine the safety of 2 consecutive courses of this drug in these patients.

- Determine the pharmacokinetics of this drug in these patients.

- Determine the toxic and adverse effects profile of this drug in these patients.

Phase II

- Primary

- Determine the objective antitumor response rate in patients treated with this drug at the MTD.

- Secondary

- Determine the overall survival time of patients treated with this drug.

- Determine the time to disease progression in patients treated with this drug.

- Determine the duration of observed objective response, using WHO criteria and measurements of serum alpha-fetoprotein concentrations, in patients treated with this drug.

- Determine the time to treatment failure in patients treated with this drug.

- Determine the safety and tolerability of intermittent treatment with this drug in these patients.

OUTLINE: This is an open-label, dose-escalation study.

- Phase I: Patients receive oral TAC-101 once daily on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of TAC-101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

- Phase II: Patients receive oral TAC-101 at the MTD (determined in phase I) once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 35-60 days.

PROJECTED ACCRUAL: A total of 6-18 patients for the phase I portion and 21-41 patients for the phase II portion will be accrued for this study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Liver Cancer

Intervention

TAC-101

Location

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

Status

Completed

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:37-0400

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