Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002923
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
1999-11-01
Brief Title:
KRN5500 in Treating Patients With Metastatic Solid Tumors
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase I Evaluation of KRN5500 NSC650426
Status:
COMPLETED
Status Verified Date:
2014-04
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 evaluate the effectiveness of KRN5500 in treating patients with metastatic solid tumors
PURPOSE Phase I trial to evaluate the effectiveness of KRN5500 in treating patients with metastatic solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and toxicities of KRN5500 in patients with solid malignant tumors II Characterize the clinical pharmacokinetics of KRN5500 in this patient population III Initiate the preliminary evaluation of antitumor activity of KRN5500 in these patients IV Determine the recommended Phase II dose of KRN5500
OUTLINE This is a dose escalation study Patients receive KRN5500 IV over 1 hour on days 1-3 Courses repeat every 21 days Patients with stable disease and partial or complete remission continue treatment for 6 months beyond complete remission Cohorts of 3 to 6 patients receive escalating doses of KRN5500 The maximum tolerated dose 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 over 9-12 months
OUTLINE This is a dose escalation study Patients receive KRN5500 IV over 1 hour on days 1-3 Courses repeat every 21 days Patients with stable disease and partial or complete remission continue treatment for 6 months beyond complete remission Cohorts of 3 to 6 patients receive escalating doses of KRN5500 The maximum tolerated dose 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 over 9-12 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 |
|---|---|---|---|
| U01CA062487 | NIH | None | None |
| P30CA022453 | NIH | None | None |
| WSU-1294 | None | None | None |
| NCI-T96-0004 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |