Phenoxodiol in Treating Patients With Refractory Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00022295
• Lead Sponsor: Kazia Therapeutics Limited

Brief 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.

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2001-08-10
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2007-03
• Study Completion: 2007-10
• Last Update Submitted: 2013-03-25
• Last Update Posted: 2013-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Center; 🇺🇸 Cleveland, Ohio, United States