Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to determine whether GTx 758 is effective in achieving and maintaining castrate testosterone levels in men with advanced prostate cancer.

Key facts

Study ID

NCT01326312

Run by

GTx

People needed

159

Starts

2011-06-01

Expected to finish

2012-12-01

Last updated by the study team

2023-06-22

Who can join

Age: 45 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• be between age 45 and 80 years of age
• be able to communicate effectively with study personnel
• ECOG is < or = 2
• screening serum total testosterone> or = 150ng/dL
• have prostate cancer, confirmed by pathology report
• have not been treated with androgen deprivation therapy(chemical or surgical
• have a clinical indication for the initiation of androgen deprivation therapy
• give written informed consent prior to any study specific procedures
• subject must agree to use acceptable methods of contraception

You may not qualify if…

• known hypersensitivity or allergy to estrogen or estrogen like drugs
• a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
• history of abnormal blood clotting,Factor V Leiden clotting disorder, thrombotic disease
• have ALT or AST above 2 times the upper normal limit
• have alkaline phosphatase greater than 3 times UNL and/or bilirubin levels above 2mg/dL at baseline
• patients cannot have brain or spinal cord metastases
• patients cannot have or be at risk for spinal cord compression from bone metastases
• received an investigational drug within a period of 90 days prior to enrollment in the study
• received the study medication previously
• currently taking testosterone, testosterone-like agents, or antiandrogens including 5-alpha reductase inhibitors within 4 weeks of randomization
• currently taking Saw Palmetto or PC-SPES (the subject may be considered for randomization after a 4 week washout period prior to randomization)
• have taken diethylstilbestrol or other estrogen products within the previous 12 months prior to randomization
• have taken body building or fertility supplements within 4 weeks of admission into the study (steroids and steroid like supplements)
• have a history of cancer other than prostate cancer, superficial bladder cancer (with no recurrence in the last 5 years) and/or non-melanoma carcinoma of the skin
• QTcB>480 msec, If the first QTcB reading exceeds 480msec two additional ECGs are to be performed separated at least 5 min apart, then take the average of the three QTcB or readings to determine if the subject satisfies the above criteria. If the average QYcB reading is >480 msec then the subject is excluded.

Where it is running

• GTx Investigative Site — Phoenix, Arizona, United States
• GTx Investigative Site — La Mesa, California, United States
• GTx Investigative Site — Los Angeles, California, United States
• GTx Investigative Site — San Bernardino, California, United States
• GTx Investigative Site — Middlebury, Connecticut, United States
• GTx Investigative Site — Aventura, Florida, United States
• GTx Investigative Site — Daytona Beach, Florida, United States
• GTx Investigative Site — Wellington, Florida, United States
• GTx Investigative Site — Marietta, Georgia, United States
• GTx Investigative Site — Springfield, Illinois, United States
• GTx Investigative Site — Fort Wayne, Indiana, United States
• GTx Investigative Site — Indianapolis, Indiana, United States
• GTx Investigative Site — Jeffersonville, Indiana, United States
• GTx Investigative Site — Annapolis, Maryland, United States
• GTx Investigative Site — Baltimore, Maryland, United States
• GTx Investigative Site — Brick, New Jersey, United States
• GTx Investigative Site — Lawrenceville, New Jersey, United States
• GTx Investigative Site — Albuquerque, New Mexico, United States
• GTx Investigative Site — Albany, New York, United States
• GTx Investigative Site — Garden City, New York, United States
• GTx Investigative Site — New York, New York, United States
• GTx Investigative Site — Oneida, New York, United States
• GTx Investigative Site — Syracuse, New York, United States
• GTx Investigative Site — Chapel Hill, North Carolina, United States
• GTx Investigative Site — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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