Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 1:03 PM
Study NCT ID:
NCT00022295
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2001-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phenoxodiol in Treating Patients With Refractory Solid Tumors
Sponsor:
Kazia Therapeutics Limited
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: