Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103220
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2005-02-07
Brief Title:
SJG-136 in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study With SJG-136 NSC 694501 in Patients With an Advanced Solid Tumor
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 SJG-136 in treating patients with advanced solid tumors Drugs used in chemotherapy such as SJG-136 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 To determine the toxicities pharmacokinetic profile and the recommended phase 2 dose of SJG-136 in patients with an advanced solid tumor
SECONDARY OBJECTIVES
I To determine preliminary efficacy data and evaluation of correlative markers of DNA damage and apoptosis in peripheral blood lymphocytes
OUTLINE This is an open-label dose-escalation study
Patients receive SJG-136 intravenously IV over 20 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 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
I To determine the toxicities pharmacokinetic profile and the recommended phase 2 dose of SJG-136 in patients with an advanced solid tumor
SECONDARY OBJECTIVES
I To determine preliminary efficacy data and evaluation of correlative markers of DNA damage and apoptosis in peripheral blood lymphocytes
OUTLINE This is an open-label dose-escalation study
Patients receive SJG-136 intravenously IV over 20 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 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
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 |
|---|---|---|---|
| MSKCC-04076 | None | None | None |
| NCI-2012-01462 | REGISTRY | None | None |
| CDR0000409581 | None | None | None |
| NCI-6818 | None | None | None |
| 04-076 | OTHER | None | None |
| 6818 | OTHER | None | None |
| U01CA069856 | NIH | CTEP | httpsreporternihgovquickSearchU01CA069856 |