Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004076
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-12-10
Brief Title:
PNU 166148 in Treating Patients With Metastatic Solid Tumors
Sponsor:
University of Glasgow
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study to Evaluate MAG-CPT PNU 166148 Given as One Single Intravenous Administration Every 4 Weeks in Patients With Advanced Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2000-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 study the effectiveness of PNU 166148 in treating patients who have metastatic solid tumors that have not responded to previous treatment
PURPOSE Phase I trial to study the effectiveness of PNU 166148 in treating patients who have metastatic solid tumors that have not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the safety profile maximum tolerated dose and dose limiting toxicities of PNU 166148 in patients with metastatic refractory solid tumors II Define a recommended dose of PNU 166148 for a Phase II study III Determine the pharmacokinetic profile and molecular weight distribution of PNU 166148 and the pharmacokinetic profile of free camptothecin in these patients IV Assess any evidence of antitumor activity in these patients treated with this regimen
OUTLINE This is a dose escalation open label multicenter study Patients receive PNU 166148 IV over 30 minutes Treatment repeats every 4 weeks for 3-6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of PNU 166148 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 3-6 patients experience dose limiting toxicity Patients are followed for 30 days and then monthly thereafter only for resolution of adverse events that occurred while on study and were attributable to study drug unless another antitumor treatment is begun
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
OUTLINE This is a dose escalation open label multicenter study Patients receive PNU 166148 IV over 30 minutes Treatment repeats every 4 weeks for 3-6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of PNU 166148 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 3-6 patients experience dose limiting toxicity Patients are followed for 30 days and then monthly thereafter only for resolution of adverse events that occurred while on study and were attributable to study drug unless another antitumor treatment is begun
PROJECTED ACCRUAL A maximum of 30 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 |
|---|---|---|---|
| P-UPJOHN-98OMCP001 | None | None | None |
| CRC-BOC-98OMCP001 | None | None | None |
| EU-99009 | None | None | None |