NCT00095186

Safety/Efficacy Study of Oral Recombinant Human Lactoferrin in Renal Cell Carcinoma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Agennix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 1.5 g \[1 vial\], twice a day (b.i.d.), 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 tumor(s) relative to either the Screening CT or the most recent CT measurement, measured according to RECIST prior to the additional cycle(s). 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.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Recombinant Human Lactoferrin

Timeline

• Start date: 2004-09-01
• Completion: 2007-03-01
• First posted: 2004-11-02
• Last updated: 2008-04-10

Locations

6 sites across 1 country: United States