Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121290
Status:
COMPLETED
Last Update Posted:
2014-02-24
First Post:
2005-07-19
Brief Title:
SJG-136 in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Dose Escalation Study of Daily x 3 Intravenous SJG-136 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-04
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 studies the side effects and best dose of SJG-136 in treating patients with solid tumors that are metastatic or cannot be removed by surgery Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose and recommended phase II dose of SJG-136 in patients with metastatic or unresectable solid tumors
II Determine the safety and dose-limiting toxic effects of this drug in these patients
III Determine preliminarily the efficacy of this drug in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetic parameters of this drug and its metabolites in these patients
II Correlate pharmacokinetic parameters with clinical effects of this drug in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive SJG-136 intravenously IV over 20 minutes once daily on days 1-3 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of SJG-136 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 At least 6 patients are treated at the MTD
After completion of study treatment patients are followed up for 30 days
I Determine the maximum tolerated dose and recommended phase II dose of SJG-136 in patients with metastatic or unresectable solid tumors
II Determine the safety and dose-limiting toxic effects of this drug in these patients
III Determine preliminarily the efficacy of this drug in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetic parameters of this drug and its metabolites in these patients
II Correlate pharmacokinetic parameters with clinical effects of this drug in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive SJG-136 intravenously IV over 20 minutes once daily on days 1-3 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of SJG-136 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 At least 6 patients are treated at the MTD
After completion of study treatment patients are followed up for 30 days
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 |
|---|---|---|---|
| NCI-2009-00085 | REGISTRY | None | None |
| CDR0000653877 | None | None | None |
| PHI 0453 | OTHER | None | None |
| 6816 | OTHER | None | None |
| P30CA068485 | NIH | None | None |
| U01CA099177 | NIH | CTEP | httpsreporternihgovquickSearchU01CA099177 |