Phase II, Dose Finding Study of GTx-758

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to determine the appropriate loading and maintenance dose of GTx-758 to reach and maintain castration for the duration of the study.

Key facts

Study ID

NCT01393119

Run by

GTx

People needed

77

Starts

2011-08-01

Expected to finish

2012-12-01

Last updated by the study team

2024-04-22

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 the study personnel
• ECOG is ≤2
• Screening serum total testosterone ≥150 ng/dL
• Have prostate cancer, confirmed by pathology report
• Have not been treated with ADT (chemical or surgical). If a subject has been treated with LHRHa for ≤6 months duration and that treatment was ≥1 years prior to the screening, the subject may be considered for the study.
• Have a clinical indication for the initiation ADT.
• Give written informed consent prior to any study specific procedures
• Subjects must agree to use acceptable methods of contraception:
• If their female partners are pregnant or lactating acceptable methods of contraception from the time of the first administration of study medication until 3 months following administration of the last dose of study medication must be used. Acceptable methods are: Condom used with spermicidal foam/gel/film/cream/suppository. If the subject has undergone surgical sterilization (vasectomy with documentation of azospermia) a condom with spermicidal foam/gel/film/cream/suppository should be used.
• If the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 3 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e. double barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a double barrier method (condom used with spermicidal foam/gel/film/cream/suppository), the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a double barrier method (condom used with spermicidal foam/gel/film/cream/suppository).
• If the female partner has undergone documented tubal ligation (female sterilization), a double barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used.
• If the female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a double barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used.

You may not qualify if…

• Known hypersensitivity or allergy to estrogen or estrogen like drugs
• Have, in the judgment of the Investigator, 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 (venous or arterial thrombotic events such as history of myocardial infarct (MI), stroke, deep vein thrombosis (DVT), and/or pulmonary embolus (PE)) NOTE: if there is evidence of an MI on the ECG that is not documented in the medical history or there is a history of MI greater than three years ago that has completely resolved, the eligibility of this subject per this exclusion criterion is an investigator decision and may require a consultation with a cardiologist.
• Have ALT or AST above 2 times the upper limit of normal (ULN)
• Have alkaline phosphatase greater than 3 times ULN and/or total bilirubin levels above 2 mg/dL at baseline
• Patients cannot have brain or spinal cord metastases
• Patients cannot have or be at high 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 (the subject may be considered for randomization after a 4 week washout period prior to 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 into this study
• 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 480 msec two additional ECGs are to be performed separated at least 5 min apart, then take the average of the three QTcB readings to determine if the subject satisfies the above criteria. If the average QTcB reading is > 480 msec then the subject is excluded.

Where it is running

• GTx Investigative Site — Glendale, Arizona, United States
• GTx Investigative Site — Phoenix, Arizona, United States
• GTx Investigative Site — La Mesa, California, United States
• GTx Investigative Site — San Bernardino, California, United States
• GTx Investigative Site — Aventura, Florida, United States
• GTx Investigative Site — Bradenton, Florida, United States
• GTx Investigative Site — St. Petersburg, Florida, United States
• GTx Investigative Site — Tampa, Florida, United States
• GTx Investigative Site — Roswell, Georgia, United States
• GTx Investigative Site — Jeffersonville, Indiana, United States
• GTx Investigative Site — Shreveport, Louisiana, United States
• GTx Investigative Site — Annapolis, Maryland, United States
• GTx Investigative Site — Towson, Maryland, United States
• GTx Investigative Site — Hamilton, New Jersey, United States
• GTx Investigative Site — Albany, New York, United States
• GTx Investigative Site — Oneida, New York, United States
• GTx Investigative Site — Syracuse, New York, United States
• GTx Investigative Site — Concord, North Carolina, United States
• GTx Investigative Site — Cincinnati, Ohio, United States
• GTx Investigative Site — Columbus, Ohio, United States
• GTx Investigative Site — Bala-Cynwyd, Pennsylvania, United States

Full record on ClinicalTrials.gov

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