Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00095186
Status:
COMPLETED
Last Update Posted:
2008-04-10
First Post:
2004-11-01
Brief Title:
SafetyEfficacy Study of Oral Recombinant Human Lactoferrin in Renal Cell Carcinoma
Sponsor:
Agennix
Organization:
Agennix
Study Overview
Official Title:
A Multi-Center Phase 2 Open Label Study of Safety and Efficacy of Oral Recombinant Human Lactoferrin rhLF Monotherapy in Patients With Advanced Renal Cell Carcinoma RCC Who Have Failed at Least One Regimen of Systemic Therapy for RCC
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if orally-administered recombinant human lactoferrin is effective in the treatment of advanced renal cell carcinoma RCC in patients who have failed at least one prior systemic therapy for RCC
Detailed Description:
This is an open label multi-center Phase 2 study Approximately 40 patients will be enrolled in a single study arm RhLF at a dose of 15 g 1 vial twice a day bid will be administered orally for two cycles each of 12 consecutive weeks followed by 2 weeks off A maximum of two additional cycles may be given if an objective response is obtained or if the patient has stable disease and no increase in the size of the target tumors relative to either the Screening CT or the most recent CT measurement measured according to RECIST prior to the additional cycles Response and progression-free survival will be evaluated for the first 20 patients enrolled If no patient has an objective response and less than 10 of the patients are alive and progression-free at 14 weeks from the start of Study Drug then the study will be terminated If in either Cycle 3 or Cycle 4 more than three out of the first ten patients or more than six out of the first twenty patients entering the cycle experience a Grade 3 or 4 Study-Drug-related adverse event no further patients will advance into Cycle 3 or Cycle 4
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