Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004926
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2000-03-07
Brief Title:
ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Oral ILX23-7553 in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2009-12
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:
RATIONALE ILX23-7553 may help solid tumor cells develop into normal cells
PURPOSE Phase I trial to study the effectiveness of ILX23-7553 in treating patients who have solid tumors that have not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of ILX23-7553 in treating patients who have solid tumors that have not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and recommended phase II dose of ILX23-7553 in patients with refractory solid tumors II Determine the principal and dose limiting toxicities of this treatment regimen in terms of duration and reversibility in this patient population III Determine the preliminary evidence of antitumor activity with this treatment regimen in these patients
OUTLINE This is a dose escalation multicenter study Patients receive oral ILX23-7553 for 5 days Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of ILX23-7553 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 10 patients experience dose limiting toxicity Patients are followed monthly for at least 2 months
PROJECTED ACCRUAL A total of 46 patients will be accrued for this study within 12-18 months
OUTLINE This is a dose escalation multicenter study Patients receive oral ILX23-7553 for 5 days Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of ILX23-7553 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 10 patients experience dose limiting toxicity Patients are followed monthly for at least 2 months
PROJECTED ACCRUAL A total of 46 patients will be accrued for this study within 12-18 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 |
|---|---|---|---|
| NCI-G00-1699 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067610 | REGISTRY | None | None |
| ILEX-VITD-101-A1 | None | None | None |