Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022295
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2001-08-10
Brief Title:
Phenoxodiol in Treating Patients With Refractory Solid Tumors
Sponsor:
Kazia Therapeutics Limited
Organization:
National Cancer Institute NCI
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V01-1663 | None | None | None |
| NOVOGEN-NV06-0024 | None | None | None |
| CCF-4269 | None | None | None |