Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003981
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
1999-11-01
Brief Title:
E7070 in Treating Patients With 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 E7070 in Patients With a Solid Tumor as a Single IV Infusion Weekly X 4 Repeated Every 6 Weeks
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of E7070 in treating patients who have solid tumors
PURPOSE Phase I trial to study the effectiveness of E7070 in treating patients who have solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of E7070 when administered to adult patients with solid tumors
Determine the qualitative and quantitative toxic effects of this drug and study the predictability duration intensity onset reversibility and dose relationship of the toxic effects in this patient population
Propose a safe dose for phase II study
Assess the pharmacokinetics of this drug at different dose levels in this patient population
Determine any possible antitumor activity of this drug in this patient population
OUTLINE This is a dose escalation study
Patients receive E7070 IV over 1 hour on days 1 8 15 and 22 Treatment continues every 6 weeks for at least 2 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of E7070 is escalated until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
Patients are followed every 3 weeks
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 12 months
Determine the maximum tolerated dose MTD of E7070 when administered to adult patients with solid tumors
Determine the qualitative and quantitative toxic effects of this drug and study the predictability duration intensity onset reversibility and dose relationship of the toxic effects in this patient population
Propose a safe dose for phase II study
Assess the pharmacokinetics of this drug at different dose levels in this patient population
Determine any possible antitumor activity of this drug in this patient population
OUTLINE This is a dose escalation study
Patients receive E7070 IV over 1 hour on days 1 8 15 and 22 Treatment continues every 6 weeks for at least 2 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of E7070 is escalated until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
Patients are followed every 3 weeks
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 12 months
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 |
|---|---|---|---|
| EISAI-E7070-E044-103 | None | None | None |
| EORTC-16975 | None | None | None |