Assessments of serum total testosterone, serum free testosterone, serum SHGB and serum PSA concentrations will be made. Bone turnover markers and the incidence and frequency of hot flashes will be assessed. CT scan of abdomen /pelvis will be conducted to asses tumor progression and soft tissue or visceral metastases. Bone scan will be conducted to to assess the development of new bone metastases. MedDRA version: 16.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System
Conditions
Interventions
Product Code: GTx-758
Pharmaceutical Form: Tablet
INN or Proposed INN: Capesaris
CAS Number: 938067-78-8
Current Sponsor code: GTx-758
Concentration unit: mg milligram(s)
Concentration type: range
Con
Sponsors
GTx, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Be over 18 years of age. 2. Be able to communicate effectively with the study personnel 3. Have histologically confirmed prostate cancer 4. Have high risk, non-metastatic, castration resistant prostate cancer (T any – N any – M0) or have metastatic castration resistant prostate cancer (T any – N any – M1). o Patients with non-metastatic castration resistant prostate cancer must have a PSA doubling time greater than 0 months and less than 10 months when calculated using the website below. PSA doubling time will be calculated using at least three serum PSA measurements that were obtained within 1 year prior to Day 1 of the study and that were collected over at least 3 months with a minimum of 28 days between any two successive measurements. PSA values must be greater than 0.2 ng/dL and have been obtained while the patient was maintained on ADT. The PSA doubling time will be calculated using first order kinetics and must be performed using the following website: http://nomograms.mskcc.org/Prostate/PsaDoublingTime.aspx o Patients with metastatic castration resistant prostate cancer must have a rising serum PSA on two successive assessments at least 2 weeks apart and serum PSA levels = 2 and 2 and < 250 ng/mL and a 25% increase above the nadir from the ADT. 5. ECOG performance status of 0 to 2 6. Have been treated with ADT (chemical or surgical) for at least 6 months 7. Have a castrate level of serum total testosterone (<50 ng/dL) 8. Have a history of serum PSA response on ADT. A serum PSA response is an undetectable level of serum PSA (=0.2 ng/mL) OR at least a 90% reduction in serum PSA from the serum PSA value prior to the initiation of treatment to <10 ng/mL. 9. Be continued on ADT throughout this study 10. Give written informed consent prior to any study specific procedures 11. Subjects must agree, if not already on anticoagulation therapy or aspirin, to take at least 81 mg aspirin daily throughout the duration of their participation in this study and for 30 days after completion of dosing with GTx-758. 12. 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., 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}. • If the female partner has undergone documented tubal ligation (female sterilization), a barrier method {condom used
Exclusion criteria
Exclusion criteria: 1. A serum PSA value = 250 ng/mL. 2. Known hypersensitivity or allergy to estrogen or estrogen like drugs; 3. Need for urgent chemotherapy, radiation therapy or surgical intervention for prostate cancer in the opinion of the investigator; 4. 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; 5. Subjects with a personal history of abnormal blood clotting or thrombotic disease (venous or arterial thrombotic events such as history of stroke, deep vein thrombosis (DVT), and/or pulmonary embolus (PE)); 6. Any subjects, as determined by a central laboratory, with: a. a modified activated protein C reaction ratio 35.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of GTx-758 on serum PSA levels in men with CRPC maintained on androgen deprivation therapy (serum PSA response and serum PSA progression).;Secondary Objective: To assess the effect of GTx-758 on serum free testosterone levels To assess the effect of GTx-758 on serum SHBG To assess the effect of GTx-758 on serum total testosterone To assess the effect of GTx-758 on adrenal gland androgen precursor hormones (DHEA and DHEAS) To assess the effect of GTx-758 on the development of new bone metastases To assess the effect of GTx-758 on soft tissue metastases (visceral and lymph nodes) To assess the effects of GTx-758 on skeletal related events To assess the effect of GTx-758 on bone turnover markers To assess the incidence and frequency of hot flashes in men on GTx-758 To assess the safety and tolerability of GTx-758 in men with prostate cancer who have failed ADT To assess the effect of GTx-758 on functional protein S, protein C, factor VII, factor VIII,antithrombin and tissue factor;Primary end point(s): The proportion of subjects with a 50% decline from baseline in serum PSA by the Day 90 visit;Timepoint(s) of evaluation of this end point: Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to serum PSA progression 2. The proportion of subjects with a =90% decline from baseline in serum PSA 3. The proportion of subjects with a =30% decline from baseline in serum PSA 4. Change in serum free testosterone levels 5. Change in serum SHBG levels 6. Change in serum total testosterone levels 7. Change in DHEA and DHEAS levels 8. Time to progression (TTP) assessed by RECIST 1.1 (soft tissue) or by PCWG2 (bone metastases) 9. Progression free Survival (PFS) assessed by RECIST 1.1 (soft tissue) or by PCWG2 (bone metastases) 10. Change in bone turnover marker levels 11. Change in incidence and frequency of hot flashes from baseline 12. Time to new or worsening SREs 13. Assess the safety and tolerability of GTx-758 in men with prostate cancer who have failed ADT 14. To assess the effect of GTx-758 on functional protein S, protein C, factor VII, factor VIII, antithrombin and tissue factor.;Timepoint(s) of evaluation of this end point: Anytime during the trial. | — |
Countries
Hungary, United States
Contacts
Public ContactMichael DeSordi
GTx, Inc.
Outcome results
None listed