Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028522
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2002-01-04
Brief Title:
RXK469 in Treating Patients With Advanced Neuroblastoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study Of RXK469 In Patients With Advanced Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2013-12
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:
This phase I trial is studying the side effects and best dose of RXK469 in treating patients with advanced neuroblastoma Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose recommended phase II dose and dose-limiting toxicity of RXK469 in two different dosing schedules in patients with advanced neuroblastoma
II Determine the safety of this drug in these patients III Determine the tolerance to this drug in these patients IV Determine the pharmacokinetics and pharmacodynamics of this drug and its metabolites in these patients
V Determine preliminarily any antineoplastic activity of this drug in these patients
OUTLINE This is a dose-escalation study
SCHEDULE A Patients receive RXK469 intravenously IV over 30 minutes on days 1 3 and 5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of RXK469 until the recommended phase II dose or 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 Once the MTD is determined additional patients are accrued and treated at the recommended phase II dose for a maximum of 20 patients treated at that dose
SCHEDULE B Once the recommended phase II dose is determined on schedule A additional patients are accrued and receive escalating doses of RXK469 IV over 30-60 minutes on day 1 beginning at a reduced dose Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Dose escalation continues as in Schedule A
I Determine the maximum tolerated dose recommended phase II dose and dose-limiting toxicity of RXK469 in two different dosing schedules in patients with advanced neuroblastoma
II Determine the safety of this drug in these patients III Determine the tolerance to this drug in these patients IV Determine the pharmacokinetics and pharmacodynamics of this drug and its metabolites in these patients
V Determine preliminarily any antineoplastic activity of this drug in these patients
OUTLINE This is a dose-escalation study
SCHEDULE A Patients receive RXK469 intravenously IV over 30 minutes on days 1 3 and 5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of RXK469 until the recommended phase II dose or 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 Once the MTD is determined additional patients are accrued and treated at the recommended phase II dose for a maximum of 20 patients treated at that dose
SCHEDULE B Once the recommended phase II dose is determined on schedule A additional patients are accrued and receive escalating doses of RXK469 IV over 30-60 minutes on day 1 beginning at a reduced dose Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Dose escalation continues as in Schedule A
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 |
|---|---|---|---|
| U01CA069852 | NIH | CTEP | httpsreporternihgovquickSearchU01CA069852 |
| NCI-2009-00013 | REGISTRY | None | None |
| UCCRC-11108B | None | None | None |
| CDR0000739128 | None | None | None |
| NCI-4570 | None | None | None |
| 11108B | OTHER | None | None |
| 4570 | OTHER | None | None |