NCT00504998

Safety/Efficacy Study of Rexin-G to Treat Pancreatic Cancer

Phase I/II Evaluation of Safety and Efficacy of Rexin-G for Recurrent or Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Epeius Biotechnologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of the adaptive trial design is to determine the over-all safety of escalating doses of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol.

Detailed description

The clinical trial is a safety and efficacy study using escalating doses of Rexin-G that incorporates a Phase II component that will evaluate the efficacy of Rexin-G using an adaptive trial design. Each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. Unlike a standard Phase I protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded. Continued Rexin-G treatment will enable the targeted genetic medicine to catch up with tumor growth, halt disease progression, and reduce tumor burden. The treatment strategy is to achieve tumor control as quickly as safely possible. The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II/III pivotal trial.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
GENETIC	Rexin-G	Dosing Schedule: 1 x 10e11 cfu 2 times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
GENETIC	Rexin-G	Dosing Schedule: 1 x 10e11 cfu three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
GENETIC	Rexin-G	Dosing Schedule: 2 x 10e11 cfu three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
GENETIC	Rexin-G	Dose Schedule: 3 x 10e11 cfu i.v. three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has less than Grade 1 or less toxicity.
GENETIC	Rexin-G	Dosing Schedule: 4 x 10e11 cfu i.v. three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-07-01
• Completion: 2011-06-01
• First posted: 2007-07-20
• Last updated: 2011-06-10

Locations

3 sites across 1 country: United States