Status:
TERMINATED
GTx-758 on Serum Prostate-specific Antigen (PSA) in Men With Castrate Resistant Prostate Cancer
Lead Sponsor:
GTx
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- Be over 18 years of age
- Be able to communicate effectively with the study personnel
- Have histologically confirmed prostate cancer
- ECOG performance status of 0 to 2
- Have been treated with ADT(chemical or surgical) for at least 6 months
- Have castrate level of serum total testosterone (\<50 ng/dL)
- 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)
- 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
- Be continued on androgen deprivation therapy throughout this study
- Give written informed consent prior to any study specific procedures
- 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
- Known hypersensitivity or allergy to estrogen or estrogen like drugs;
- Have symptomatic metastatic prostate cancer
- 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;
- 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))
- Symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris, cardiac arrhythmia
- 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
- 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 (may be eligible if allow a 6 week washout period after stopping antiandrogens);
- History of prior treatment of cancer chemotherapy agent (other than hormone therapy) or radiopharmaceutical for prostate cancer.
- Have taken ketoconazole within the previous 12 months prior to randomization into this study
- Have taken diethylstilbestrol or other estrogen products, ketoconazole, or abiraterone 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
- Have been previously diagnosed with cancer (other than prostate cancer, superficial bladder cancer, or non-melanoma skin cancer).
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01420861
Start Date
September 1 2011
End Date
December 1 2012
Last Update
October 6 2023
Active Locations (7)
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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