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Study to Evaluate Safety and Feasibility of Using OGX-011 in Combination With Second Line Chemotherapy in Patients With HRPC

2014-08-27 03:44:33 | BioPortfolio

Summary

This study is for patients with cancer of the prostate gland, which has metastasized or spread outside the prostate to other parts of the body. Patients have already been treated with a drug called docetaxel or Taxotere® (with or without the addition of a steroid called prednisone) some time in the recent past. They either did not respond to this therapy or responded to this therapy, but now the cancer is progressing (growing larger or has spread to other areas of the body).

OGX-011 is an experimental drug that has been shown to increase the effectiveness of chemotherapy in several kinds of tumors, including prostate cancer. OGX-011 has been shown to increase the anti-tumor effectiveness of docetaxel in animal tumor models. In similar animal studies, OGX-011 has also been shown to reverse resistance to docetaxel.

Docetaxel (Taxotere®) has anticancer activity in several cancers including prostate and is approved by Health Canada and the Food and Drug Administration for the treatment of patients with prostate cancer.

Description

A multicenter, open label trial, where 40 patients were to be randomized to receive OGX-011 in combination with docetaxel/prednisone or mitoxantrone/prednisone for up to 9 cycles. An additional 20 patients will receive OGX-011 in combination with docetaxel/prednisone for up to 9 cycles. All patients will be followed for survival.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

Docetaxel, Prednisone, OGX-011

Location

Tom Baker Cancer Centre
Calgary
Alberta
Canada

Status

Active, not recruiting

Source

OncoGenex Technologies

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:33-0400

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Medical and Biotech [MESH] Definitions

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.

Tumors or cancer of the PROSTATE.

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