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Phase II, Open-label, Loading and Maintenance Dose Finding Study of GTx-758 in Men With Prostate Cancer


Phase 2
45 Years
80 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Phase II, Open-label, Loading and Maintenance Dose Finding Study of GTx-758 in Men With Prostate Cancer


Inclusion Criteria:



1. Be between age 45 and 80 years of age

2. Be able to communicate effectively with the study personnel

3. ECOG is ≤2

4. Screening serum total testosterone ≥150 ng/dL

5. Have prostate cancer, confirmed by pathology report

6. 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.

7. Have a clinical indication for the initiation ADT.

8. Give written informed consent prior to any study specific procedures

9. 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.

Exclusion Criteria:

1. Known hypersensitivity or allergy to estrogen or estrogen like drugs

2. 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

3. 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.

4. Have ALT or AST above 2 times the upper limit of normal (ULN)

5. Have alkaline phosphatase greater than 3 times ULN and/or total bilirubin levels
above 2 mg/dL at baseline

6. Patients cannot have brain or spinal cord metastases

7. Patients cannot have or be at high risk for spinal cord compression from bone
metastases.

8. Received an investigational drug within a period of 90 days prior to enrollment in
the study

9. Received the study medication previously

10. 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)

11. Currently taking Saw Palmetto or PC-SPES (the subject may be considered for
randomization after a 4 week washout period prior to randomization)

12. Have taken diethylstilbestrol or other estrogen products within the previous 12
months prior to randomization into this study

13. Have taken body building or fertility supplements within 4 weeks of admission into
the study (steroids and steroid like supplements)

14. 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.

15. 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of subjects that reach castration by Day 28

Outcome Time Frame:

Day 1-28

Safety Issue:

No

Principal Investigator

Ronald Morton, MD

Investigator Role:

Study Director

Investigator Affiliation:

GTx

Authority:

United States: Food and Drug Administration

Study ID:

G200710

NCT ID:

NCT01393119

Start Date:

August 2011

Completion Date:

February 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

GTx Investigative SitePhoenix, Arizona  85032
GTx Investigative SiteLa Mesa, California  91942
GTx Investigative SiteAventura, Florida  33180
GTx Investigative SiteMarietta, Georgia  30060
GTx Investigative SiteFort Wayne, Indiana  46825
GTx Investigative SiteAnnapolis, Maryland  21401
GTx Investigative SiteBrick, New Jersey  08724
GTx Investigative SiteAlbany, New York  12208
GTx Investigative SiteChapel Hill, North Carolina  27514
GTx Investigative SiteCincinnati, Ohio  45212
GTx Investigative SiteBala Cynwyd, Pennsylvania  19004
GTx Investigative SiteShreveport, Louisiana  71106