Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00487786
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2007-06-15
Brief Title:
Safety Study of an Antisense Product in Prostate Ovarian NSCL Breast or Bladder Cancer
Sponsor:
Achieve Life Sciences
Organization:
Achieve Life Sciences
Study Overview
Official Title:
A Phase 1 Study Evaluating A Second Generation Antisense Oligonucleotide OGX 427 That Inhibits Heat Shock Protein 27 Hsp27
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None