NCT00417287

Phase II Study of PX-12 in Patients With Advanced Pancreatic Cancer

A Randomized Phase II Open-Label Study of Two Different Dose Levels of PX-12 in Patients With Advanced Carcinoma of the Pancreas Whose Tumors Have Progressed on Gemcitabine or on a Gemcitabine-Containing Combination

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Cascadian Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to evaluate the clinical efficacy, biologic activity (inhibition of PX-12 target thioredoxin-1) and effects of an expired metabolite of PX-12 in patients with advanced pancreatic cancer.

Detailed description

In a Phase I trial, PX-12 demonstrated anti-tumor activity and pharmacodynamic activity across a wide dose range. At higher doses, one side effect of the agent was a garlic-like odor of an expired metabolite. This study is being conducted to evaluate the clinical efficacy, biologic activity (inhibition of PX-12 target thioredoxin-1) and effects of the expired metabolite at two dose levels of PX-12. This study will determine if the efficacy and biologic activity achieved at either of the two dose levels is sufficient to proceed to further studies without pushing to the maximally tolerated dose.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
DRUG	PX-12	3 hour intravenous infusion as a dose of either 54 mg/m2 or 128 mg/m2 daily for 5 days every three weeks.

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-01-01
• Last updated: 2018-05-16

Locations

3 sites across 1 country: United States