NCT00487786

Safety Study of an Antisense Product in Prostate, Ovarian, NSCL, Breast or Bladder Cancer

A Phase 1 Study Evaluating A Second Generation Antisense Oligonucleotide (OGX 427) That Inhibits Heat Shock Protein 27 (Hsp27

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Achieve Life Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is for patients with cancer who have failed potentially curative treatments or for whose disease a curative treatment does not exist. OGX-427 is an antisense product that inhibits expression of one of the heat shock proteins. Decreasing this heat shock protein (Hsp27) should result in down regulation of pathways implicated in cancer progression and development of resistance to treatment.

Detailed description

This study is for patients with breast, prostate, ovarian, non-small cell lung (NSCL) or bladder cancer who have failed potentially curative treatments or for whose disease a curative treatment does not exist. OGX-427 is a second-generation ASO that inhibits expression of Hsp27. Hsp27 is one of the heat shock proteins. Hsp27 increases with cell stress, including cytotoxic chemotherapy, radiation therapy and hormone therapy and has been shown to inhibit cell death. Thus, decreasing Hsp27 as a cancer therapy is attractive as a therapy as it should result in down regulation of pathways implicated in cancer progression and development of resistance to treatment. A number of in vitro and in vivo pharmacological studies have demonstrated that OGX-427 has single-agent activity in reducing Hsp27, inhibiting cell growth and inducing cell death in several human cancer cell lines. OGX-427 has also demonstrated chemosensitizing activity in studies using cell lines and animal models in combination with several cytotoxic drugs, including docetaxel. Docetaxel (Taxotere®) has anticancer activity in breast, prostate, ovarian, non-small cell lung and bladder cancer. Docetaxel has been approved by Health Canada and the Food and Drug Administration for the treatment of patients with breast, prostate, ovarian and non-small cell lung cancer.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	OGX-427	OGX-427 injection at 200mg, 400mg, 600mg, 800mg or 1000mg once a week until withdrawn
DRUG	Docetaxel	injection - 75 mg/M2 IV on Day 1 every 21 days for cohorts 6 \& 7 only, together with appropriate dose of OGX-427 until withdrawn from study

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-06-01
• Completion: 2011-10-01
• First posted: 2007-06-19
• Last updated: 2016-01-18

Locations

3 sites across 2 countries: United States, Canada