Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095797
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
2004-11-09
Brief Title:
XK469R in Treating Patients With Refractory Hematologic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of XK469R NSC 698215 in Patients With Refractory Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Phase I trial to study the effectiveness of XK469R in treating patients who have refractory hematologic cancer Drugs used in chemotherapy such XK469R work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the dose-limiting toxicity maximum tolerated dose and recommended phase II dose of XK469R in patients with refractory hematologic malignancies
II Determine the pharmacokinetics of this drug in these patients
SECONDARY OBJECTIVES
I Determine the presence of genetic variations potentially affecting XK469R disposition in patients treated with this drug
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive XK469R IV over 30-60 minutes on days 1 3 and 5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of XK469R 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 A total of 12 patients receive treatment at the MTD
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
I Determine the dose-limiting toxicity maximum tolerated dose and recommended phase II dose of XK469R in patients with refractory hematologic malignancies
II Determine the pharmacokinetics of this drug in these patients
SECONDARY OBJECTIVES
I Determine the presence of genetic variations potentially affecting XK469R disposition in patients treated with this drug
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive XK469R IV over 30-60 minutes on days 1 3 and 5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of XK469R 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 A total of 12 patients receive treatment at the MTD
PROJECTED ACCRUAL A total of 60 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 |
|---|---|---|---|
| CDR0000393836 | REGISTRY | PDQ Physician Data Query | None |
| MDA-2004-0154 | None | None | None |
| U10CA62461 | OTHER_GRANT | None | None |