Pharmacokinetic Study of Abiraterone Acetate Tablets and Capsules Followed by Safety and Efficacy Evaluation of Continuous Tablet Dosing
Summary
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
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Prostate Cancer
Intervention
abiraterone acetate plus 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/NCT00600535
- 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.
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.
Megestrol Acetate
Megestrol acetate is a progestogen with actions and uses similar to those of the progestogens in general. It also has anti-androgenic properties. It is given by mouth in the palliative treatment or as an adjunct to other therapy in endometrial carcinoma and in breast cancer. Megestrol acetate has been approved to treat anorexia and cachexia. (From Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
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.
Fenretinide
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.
Clinical Trials
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...
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...
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide acetate, and goserelin, may lessen the amount of androgens...
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...
To evaluate anti-tumor effects and safety of CB7630 in patients with advanced prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy
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...
