Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027677
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2001-12-07
Brief Title:
Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase I Study To Determine The Safety Of Halofuginone In Patients With A Solid Progressive Tumor
Status:
COMPLETED
Status Verified Date:
2012-07
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 Halofuginone hydrobromide may stop the growth of solid tumors by stopping blood flow to the tumor
PURPOSE Phase I trial to study the effectiveness of halofuginone hydrobromide in treating patients who have progressive advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of halofuginone hydrobromide in treating patients who have progressive advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the toxicity profile maximum tolerated dose and dose-limiting toxic effects of halofuginone hydrobromide in patients with progressive advanced solid tumors
Establish a recommended dose of this drug for phase II study
OUTLINE This is a dose-escalation multicenter study
Patients receive oral halofuginone hydrobromide once daily on days 1 and 4-14 of course 1 and on days 1-14 of subsequent courses Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-3 patients receive escalating doses of halofuginone hydrobromide until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 20 of patients experience acute dose-limiting toxicity After the MTD is reached 6-12 additional patients are treated at dose levels preceding the MTD until the recommended dose for phase II study is determined The recommended dose for phase II study is defined as the dose preceding the MTD that allows a 90 dose intensity for 2 months with no greater than grade 2 toxicity in 80 of the patients
Patients are followed every 8 weeks until disease progression or initiation of another treatment
PROJECTED ACCRUAL Approximately 7-40 patients will be accrued for this study
Determine the toxicity profile maximum tolerated dose and dose-limiting toxic effects of halofuginone hydrobromide in patients with progressive advanced solid tumors
Establish a recommended dose of this drug for phase II study
OUTLINE This is a dose-escalation multicenter study
Patients receive oral halofuginone hydrobromide once daily on days 1 and 4-14 of course 1 and on days 1-14 of subsequent courses Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-3 patients receive escalating doses of halofuginone hydrobromide until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 20 of patients experience acute dose-limiting toxicity After the MTD is reached 6-12 additional patients are treated at dose levels preceding the MTD until the recommended dose for phase II study is determined The recommended dose for phase II study is defined as the dose preceding the MTD that allows a 90 dose intensity for 2 months with no greater than grade 2 toxicity in 80 of the patients
Patients are followed every 8 weeks until disease progression or initiation of another treatment
PROJECTED ACCRUAL Approximately 7-40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COLLGARD-EORTC-16007 | None | None | None |
| EORTC-16007 | None | None | None |