Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003985
Status:
WITHDRAWN
Last Update Posted:
2012-07-11
First Post:
1999-11-01
Brief Title:
KRN7000 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 of KRN7000 in Patients With Solid Tumor Treated With a Weekly Intravenous Administration Schedule
Status:
WITHDRAWN
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 Biological therapies such as KRN7000 use different ways to stimulate the immune system and stop cancer cells from growing
PURPOSE Phase I trial to study the effectiveness of KRN7000 in treating patients who have solid tumors that have not responded to previous treatment
PURPOSE Phase I trial to study the effectiveness of KRN7000 in treating patients who have solid tumors that have not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the safety profile and maximum tolerated dose of KRN7000 in patients with solid tumors II Assess the biological and immunological parameters that would suggest the optimal biologically active dose of KRN7000 in these patients III Determine the pharmacokinetics of KRN7000 at the different dose levels in these patients IV Measure any antitumor activity in these patients treated with this regimen
OUTLINE This is a dose escalation study Patients receive KRN7000 by slow intravenous injection on days 1 8 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients each receive escalating doses of KRN7000 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study within 18 months
OUTLINE This is a dose escalation study Patients receive KRN7000 by slow intravenous injection on days 1 8 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients each receive escalating doses of KRN7000 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| KIRIN-EORTC-13972 | None | None | None |
| EORTC-13972 | None | None | None |