Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004239
Status:
TERMINATED
Last Update Posted:
2016-07-04
First Post:
2000-01-28
Brief Title:
506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase I Study of Compound 506U78 NSC 686673 in Patients With Hematologic Malignancies and Renal or Hepatic Impairment
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
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 cancer cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of 506U78 in treating patients who have hematologic cancer and kidney or liver impairment
PURPOSE Phase I trial to study the effectiveness of 506U78 in treating patients who have hematologic cancer and kidney or liver impairment
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of 506U78 in patients with hematologic malignancies and renal or hepatic impairment II Establish dosing guidelines for this drug in this patient population III Determine the toxicities and pharmacokinetics of this drug in these patients
OUTLINE Patients are stratified into 5 groups according to renal and hepatic function Group 1 Normal renal function and normal hepatic function Group 2 Moderate renal impairment and normal hepatic function Group 3 Severe renal impairment and normal hepatic function Group 4 End stage renal impairment and normal hepatic function Group 5 Normal renal function and moderate hepatic impairment Group 1 Patients receive 506U78 IV over 2 hours on days 1 3 and 5 Groups 2-5 Patients receive 506U78 IV over 2 hours on days 1 3 and 5 Dose escalation occurs independently in each of the treatment groups Cohorts of 3-6 patients receive escalating doses of 506U78 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 toxicities Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL Approximately 60 patients will be accrued for this study
OUTLINE Patients are stratified into 5 groups according to renal and hepatic function Group 1 Normal renal function and normal hepatic function Group 2 Moderate renal impairment and normal hepatic function Group 3 Severe renal impairment and normal hepatic function Group 4 End stage renal impairment and normal hepatic function Group 5 Normal renal function and moderate hepatic impairment Group 1 Patients receive 506U78 IV over 2 hours on days 1 3 and 5 Groups 2-5 Patients receive 506U78 IV over 2 hours on days 1 3 and 5 Dose escalation occurs independently in each of the treatment groups Cohorts of 3-6 patients receive escalating doses of 506U78 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 toxicities Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL Approximately 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 |
|---|---|---|---|
| CDR0000067483 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-69803 | None | None | None |