Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003773
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
1999-11-01
Brief Title:
IM-862 in Treating Patients With Recurrent Ovarian Cancer
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Phase I Study of Escalating Doses of IM-862 in Patients With Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2014-05
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 IM-862 may stop the growth of ovarian cancer by stopping blood flow to the tumor
PURPOSE Phase I trial to study the effectiveness of IM-862 in treating patients who have recurrent ovarian cancer after treatment with chemotherapy and surgery
PURPOSE Phase I trial to study the effectiveness of IM-862 in treating patients who have recurrent ovarian cancer after treatment with chemotherapy and surgery
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of IM-862 administered intranasally in patients with recurrent ovarian cancer II Determine the toxicity of this regimen in this patient population III Obtain preliminary data regarding the efficacy of this drug in these patients IV Evaluate the effect of this drug in serum levels of vascular endothelial growth factor and transforming growth factor in this population
OUTLINE This is a dose escalation study Patients receive IM-862 intranasally daily Treatment continues for 6 months in the absence of unacceptable toxicity or disease progression At the physicians discretion further treatment may be given if the patient is still responding after 6 months of treatment The dose of IM-862 is escalated in cohorts of 10-20 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 10 or 5 of 20 patients experience dose limiting toxicity
PROJECTED ACCRUAL A total of 20-70 evaluable patients will be accrued for this study within 6-9 months
OUTLINE This is a dose escalation study Patients receive IM-862 intranasally daily Treatment continues for 6 months in the absence of unacceptable toxicity or disease progression At the physicians discretion further treatment may be given if the patient is still responding after 6 months of treatment The dose of IM-862 is escalated in cohorts of 10-20 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 10 or 5 of 20 patients experience dose limiting toxicity
PROJECTED ACCRUAL A total of 20-70 evaluable patients will be accrued for this study within 6-9 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-G99-1503 | None | None | None |
| LAC-USC-5O984 | None | None | None |