Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003976
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 on a Single IV Infusion Repeated Every 3 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 I Determine the maximum tolerated dose of E7070 in patients with solid tumors II Assess the qualitative and quantitative toxicity in terms of predictability duration intensity onset reversibility and dose relationship of this treatment regimen in this patient population III Determine a safe dose for phase II evaluation IV Assess the pharmacokinetics of this treatment regimen in these patients V Determine any possible antitumor activity of this regimen in these patients
OUTLINE This is a dose escalation study Patients receive E7070 IV over 1 hour once every 3 weeks Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of E7070 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study within 12 months
OUTLINE This is a dose escalation study Patients receive E7070 IV over 1 hour once every 3 weeks Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of E7070 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study within 12 months
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 |
|---|---|---|---|
| EISAI-E7070-E044-101 | None | None | None |
| EORTC-16973 | None | None | None |