MedTrace Logo

OGX-427 in Castration Resistant Prostate Cancer Patients

NCT01120470 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2019-02-15

No results posted yet for this study

Summary

This study is being offered to patients who have castrate-resistant (also known as hormone-refractory) prostate cancer. The cancer has metastasized or spread outside the prostate area to other parts of the body or has recurred in the pelvic area after treatment.

The purpose of this clinical research study is to determine whether OGX-427 is able to slow the progression of prostate cancer and symptoms of disease when given with prednisone better than when prednisone is given alone in patients with prostate cancer whose disease has spread outside the prostate area.

Research Hypothesis:

That adding OGX-427 to prednisone treatment will produce a progression free rate of 20%.

Conditions

  • Castration Resistant Prostate Cancer

Interventions

DRUG

OGX-427

OGX-427: Starting within 5 days of randomization, three loading doses at 600 mg IV within the first 10 days of initiating treatment, followed by weekly doses of 1000 mg IV

DRUG

Prednisone

Control Arm: Prednisone: 5 mg BID orally starting within 4 days following randomization Experimental Arm: Prednisone: 5 mg BID orally starting within 4 days following randomization and at least 24 hours prior to first loading dose of OGX-427

Sponsors & Collaborators

  • Achieve Life Sciences

    collaborator INDUSTRY

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Kim N Chi, MD · BC Cancer Agency - Vancouver Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-10-31
Completion
2014-06-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01120470 on ClinicalTrials.gov