GTx-758 on Serum Prostate-specific Antigen (PSA) in Men With Castrate Resistant Prostate Cancer
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the effect of GTx-758 on Serum Prostate-specific antigen (PSA) levels in men with castrate resistant prostate cancer who are maintained on androgen deprivation therapy (Serum PSA response and Serum PSA progression)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1000 mg GTx-758 subjects will receive daily doses of 1000 mg GTx-758 |
Drug: GTx-758
two GTx 758 tablets per day
|
Outcome Measures
Primary Outcome Measures
- Decline in serum PSA [30 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Be over 18 years of age
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Be able to communicate effectively with the study personnel
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Have histologically confirmed prostate cancer
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ECOG performance status of 0 to 2
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Have been treated with ADT(chemical or surgical) for at least 6 months
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Have castrate level of serum total testosterone (<50 ng/dL)
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Have a history of serum PSA response after initiation of ADT, serum PSA response is at least a 90% reduction in serum PSA to <10 ng/mL OR undetectable level of serum PSA (less tan or =0.2 ng/mL)
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Have rising serum PSA on two successive assessments at least 2 weeks apart and serum PSA levels ≥ 2 ng/mL or 2ng/mL and a 25% increase over the nadir after the initiation of ADT
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Be continued on androgen deprivation therapy throughout this study
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Give written informed consent prior to any study specific procedures
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Subjects must agree to use acceptable methods of contraception:
oIf 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. oIf 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. barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a 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 barrier method {condom used with spermicidal foam/gel/film/cream/suppository}. oIf the female partner has undergone documented tubal ligation (female sterilization), a barrier method {condom used with spermicidal foam/gel/film/cream/suppository} should also be used. oIf the female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and a barrier method {condom with spermicidal foam/gel/film/cream/suppository} should also be used.
Exclusion Criteria:
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Known hypersensitivity or allergy to estrogen or estrogen like drugs;
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Have symptomatic metastatic prostate cancer
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Any disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk;
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History of abnormal blood clotting, Factor V Leiden clotting disorder, thrombotic disease (venous or arterial thrombotic events such as history of stroke, deep vein thrombosis (DVT), and/or pulmonary embolus (PE))
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Symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris, cardiac arrhythmia
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The presence of consistently abnormal laboratory values which are considered clinically significant. In addition, no subject with liver enzymes (ALT or AST) above 2 times the ULN, total bilirubin above 2 times the ULN, or serum creatinine above 1.5 ULN will be admitted to the study
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Received an investigational drug within a period of 90 days prior to enrollment in the study
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Received the study medication previously
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Currently taking testosterone, testosterone-like agents, or antiandrogens,including 5-alpha reductase inhibitors (may be eligible if allow a 6 week washout period after stopping antiandrogens);
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History of prior treatment of cancer chemotherapy agent (other than hormone therapy) or radiopharmaceutical for prostate cancer.
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Have taken ketoconazole within the previous 12 months prior to randomization into this study
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Have taken diethylstilbestrol or other estrogen products, ketoconazole, or abiraterone within the previous 12 months prior to randomization into this study
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Have taken body building or fertility supplements within 4 weeks of admission into the study
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Have been previously diagnosed with cancer (other than prostate cancer, superficial bladder cancer, or non-melanoma skin cancer).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GTx Investigative Site | San Bernardino | California | United States | 92404 |
| 2 | GTx Investigational Site | Jeffersonville | Indiana | United States | 47130 |
| 3 | GTx Investigative Site | Albuquerque | New Mexico | United States | 87109 |
| 4 | GTx Investigative Site | Syracuse | New York | United States | 13210 |
| 5 | GTx Investigative Site | Bala Cynwyd | Pennsylvania | United States | 19004 |
| 6 | GTx Investigative Site | San Antonio | Texas | United States | 78229 |
| 7 | GTx Investigative Site | Virginia Beach | Virginia | United States | 23462 |
Sponsors and Collaborators
- GTx
Investigators
- Study Director: Mitchell Steiner, MD, GTx
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- G200707