Clinical Study of Abiraterone Acetate and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Summary
To evaluate anti-tumor effects and safety of CB7630 in patients with advanced prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy
Description
In order to fully assess the efficacy of abiraterone acetate (CB7630) in patients who have been treated with docetaxel-based chemotherapy, this study is designed to assess anti-tumor activity of CB7630 given with prednisone in prostate cancer patients who have progressive disease after docetaxel-based chemotherapy.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Hormone Refractory Prostate Cancer
Intervention
Abiraterone acetate (CB7630), Prednisone/prednisolone
Location
UCLA
Los Angeles
California
United States
90024
Status
Active, not recruiting
Source
Cougar Biotechnology, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00485303
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Prednisone
A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
Megestrol
17-Hydroxy-6-methylpregna-3,6-diene-3,20-dione. A progestational hormone used most commonly as the acetate ester. As the acetate, it is more potent than progesterone both as a progestagen and as an ovulation inhibitor. It has also been used in the palliative treatment of breast cancer.
Antineoplastic Agents, Hormonal
Antineoplastic agents that are used to treat hormone-sensitive tumors. Hormone-sensitive tumors may be hormone-dependent, hormone-responsive, or both. A hormone-dependent tumor regresses on removal of the hormonal stimulus, by surgery or pharmacological block. Hormone-responsive tumors may regress when pharmacologic amounts of hormones are administered regardless of whether previous signs of hormone sensitivity were observed. The major hormone-responsive cancers include carcinomas of the breast, prostate, and endometrium; lymphomas; and certain leukemias. (From AMA Drug Evaluations Annual 1994, p2079)
Prostatic Secretory Proteins
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.
Prostate-specific Antigen
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.
Clinical Trials
Phase I/II Study of Abiraterone Acetate in Hormone Refractory Prostate Cancer
This is an open label phase I/II study to evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activities of an oral CYP17 (17alpha-hydroxylase and C17,20-lyase) inhibit...
To compare the total exposure of CB7630 administered in capsule formulation with that in tablet formulation in patients with prostate cancer under fasted and fed conditions
The purpose of this research study is to determine the effects of abiraterone acetate plus leuprolide acetate and prednisone versus leuprolide acetate alone on hormone levels in the blood...
A QT/QTc and Multi-dose Pharmacokinetic (PK) Study of Abiraterone Acetate
This is a phase 1B study to determine the effect of abiraterone acetate and prednisone on the conduction of electricity in the heart and the blood levels of abiraterone acetate and abirate...
Neo-adjuvant Abiraterone + LHRH Versus LHRH in Prostate Cancer
The goal of this clinical research study is to find out how treatment with abiraterone acetate in combination with prednisone and a Luteinizing Hormone-Releasing Hormone (LHRH) analogue ch...
PubMed Articles
Abiraterone acetate: in metastatic castration-resistant prostate cancer.
Oral abiraterone acetate, in combination with prednisone/prednisolone, is used to treat patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel-cont...
Abiraterone and Increased Survival in Metastatic Prostate Cancer.
To the Editor: De Bono et al. (May 26 issue)(1) report that the CYP17 inhibitor abiraterone increased survival in patients with metastatic castration-resistant prostate cancer. However, CYP17 inhibiti...
Abiraterone and Increased Survival in Metastatic Prostate Cancer.
To the Editor: De Bono et al. (May 26 issue)(1) report that the CYP17 inhibitor abiraterone increased survival in patients with metastatic castration-resistant prostate cancer. However, CYP17 inhibiti...
Abiraterone and Increased Survival in Metastatic Prostate Cancer.
To the Editor: De Bono et al. (May 26 issue)(1) report that the CYP17 inhibitor abiraterone increased survival in patients with metastatic castration-resistant prostate cancer. However, CYP17 inhibiti...
Abiraterone and Increased Survival in Metastatic Prostate Cancer.
To the Editor: De Bono et al. (May 26 issue)(1) report that the CYP17 inhibitor abiraterone increased survival in patients with metastatic castration-resistant prostate cancer. However, CYP17 inhibiti...
