NCT01234025

Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Docetaxel and Prednisone (CRPC)

A Phase 1b/2 Study of Docetaxel and Prednisone, With or Without ISIS 183750 (an eIF4E Inhibitor), in Patients With Castrate-Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the safety, tolerability and progression-free survival of patients with Castrate-Resistant Prostate Cancer treated with ISIS EIF4E Rx in combination with docetaxel and prednisone.

Conditions

• Castrate-Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	ISIS EIF4E Rx	800 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle.
DRUG	ISIS EIF4E Rx	1000 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle.
DRUG	ISIS EIF4E Rx	(Dose identified in Part 1)ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle.
DRUG	Prednisone	5 mg administered orally twice daily on days 1, 8, 15 and 22 of each cycle
DRUG	Docetaxel	75 mg/m2 administered as a 1-hour intravenous infusion on day 1 of each cycle

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-05-01
• Completion: 2013-12-01
• First posted: 2010-11-04
• Last updated: 2023-10-06

Locations

38 sites across 6 countries: United States, Hungary, Poland, Puerto Rico, Romania, Russia

Regulatory

• FDA-regulated drug study