Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017238
Status:
COMPLETED
Last Update Posted:
2013-01-11
First Post:
2001-06-06
Brief Title:
KRN5500 in Treating Patients With Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of KRN5500 NSC 650426 Given as a 72 Hour Continuous IV Infusion Every 21 Days in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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 KRN5500 in treating patients who have solid tumors Drugs used in chemotherapy such as KRN5500 work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To establish the MTD and identify the DLTs of the investigational agent KRN5500 when administered by a 72-hr continuous iv infusion to patients with solid tumors who have failed standard therapy or for whom no standard therapy exists
II To establish and assess the safety of an appropriate dose for phase II studies
III To characterize the pharmacokinetics of KRN5500 in patients when administered by a 72 hr continuous IV infusion
IV To characterize the response to KRN5500 by FLT-PET scanning at the MTD
SECONDARY OBJECTIVES
I To describe any preliminary evidence of antitumor activity II Establish pharmacodynamic relationships for the pharmacological effect of the drug upon surrogate markers of activity and host toxicity
III To compare the toxicity profiles for the 1 hr iv infusion and 72 hr continuous iv infusion administration schedules
OUTLINE This is a dose-escalation multicenter study
Patients receive KRN5500 IV over 24-72 hours on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-3 patients receive KRN5500 at the starting dose over escalating infusion durations After the longest duration of infusion time is safely reached cohorts of 3-6 patients receive escalating doses of KRN5500 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to receive treatment with KRN5500 at the recommended phase II dose
Patients are followed every 4 weeks until resolution of all toxicity
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 9-12 months
I To establish the MTD and identify the DLTs of the investigational agent KRN5500 when administered by a 72-hr continuous iv infusion to patients with solid tumors who have failed standard therapy or for whom no standard therapy exists
II To establish and assess the safety of an appropriate dose for phase II studies
III To characterize the pharmacokinetics of KRN5500 in patients when administered by a 72 hr continuous IV infusion
IV To characterize the response to KRN5500 by FLT-PET scanning at the MTD
SECONDARY OBJECTIVES
I To describe any preliminary evidence of antitumor activity II Establish pharmacodynamic relationships for the pharmacological effect of the drug upon surrogate markers of activity and host toxicity
III To compare the toxicity profiles for the 1 hr iv infusion and 72 hr continuous iv infusion administration schedules
OUTLINE This is a dose-escalation multicenter study
Patients receive KRN5500 IV over 24-72 hours on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-3 patients receive KRN5500 at the starting dose over escalating infusion durations After the longest duration of infusion time is safely reached cohorts of 3-6 patients receive escalating doses of KRN5500 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to receive treatment with KRN5500 at the recommended phase II dose
Patients are followed every 4 weeks until resolution of all toxicity
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 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 |
|---|---|---|---|
| U01CA062490 | NIH | None | httpsreporternihgovquickSearchU01CA062490 |
| 00-102 | None | None | None |