NCT00022295

Phenoxodiol in Treating Patients With Refractory Solid Tumors

Phase IB Study of Phenoxodiol Given by Constant Intravenous Infusion in Patients With Solid Neoplasms (With the Exception of Breast Cancer) Whose Tumors Are Refractory to Standard Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Kazia Therapeutics Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractory solid tumors.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of phenoxodiol in patients with refractory solid tumors. * Determine the steady-state pharmacokinetics of this drug in these patients. * Determine the tumor response in patients treated with this drug. OUTLINE: This is a multicenter, dose-escalation study. Patients receive phenoxodiol IV continuously over days 1-7. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of phenoxodiol 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. Patients are followed at 4 weeks. PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	idronoxil

Timeline

• Start date: 2001-08-01
• Completion: 2007-10-01
• First posted: 2003-01-27
• Last updated: 2013-03-26

Locations

1 site across 1 country: United States