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Phase II, Dose Finding Study of GTx-758

This study has been terminated.
(FDA Clinical Hold)
Sponsor:
Information provided by (Responsible Party):
GTx
ClinicalTrials.gov Identifier:
NCT01393119
First received: July 11, 2011
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: GTx-758
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II, Open-label, Loading and Maintenance Dose Finding Study of GTx-758 in Men With Prostate Cancer

Resource links provided by NLM:


Further study details as provided by GTx:

Primary Outcome Measures:
  • Proportion of subjects that reach castration by Day 28 [ Time Frame: Day 1-28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • proportion of subjects that reach castration by day 28 and are maintained in the castrate range through Day 56 [ Time Frame: Day 29-56 ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: August 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3000mg GTx-758 daily
loading dose 3000mg GTx-758 daily + maintenance dose of 1000mg
Drug: GTx-758
Experimental: 3000 mg GTx-758 daily
loading dose of 3000mg GTx-758 daily + maintenance dose of 2000mg GTx-758 daily
Drug: GTx-758
Experimental: 1500 mg GTx-758 BID
Loading dose of 1500 mg GTx-758 BID + maintenance dose of 1000mg GTx-758 daily
Drug: GTx-758
Experimental: 1500mg GTx-758 BID
loading dose of 1500mg of GTx-758 BID + maintenance dose of 2000mg GTx-758 daily
Drug: GTx-758

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393119

Locations
United States, Arizona
GTx Investigative Site
Glendale, Arizona, United States, 85306
GTx Investigative Site
Phoenix, Arizona, United States, 85032
United States, California
GTx Investigative Site
La Mesa, California, United States, 91942
GTx Investigative Site
San Bernardino, California, United States, 92404
United States, Florida
GTx Investigative Site
Aventura, Florida, United States, 33180
GTx Investigative Site
Bradenton, Florida, United States, 34205
GTx Investigative Site
St. Petersburg, Florida, United States, 33710
GTx Investigative Site
Tampa, Florida, United States, 33607
United States, Georgia
GTx Investigative Site
Roswell, Georgia, United States, 30076
United States, Indiana
GTx Investigative Site
Jeffersonville, Indiana, United States, 47130
United States, Louisiana
GTx Investigative Site
Shreveport, Louisiana, United States, 71106
United States, Maryland
GTx Investigative Site
Annapolis, Maryland, United States, 21401
GTx Investigative Site
Towson, Maryland, United States, 21204
United States, New Jersey
GTx Investigative Site
Hamilton, New Jersey, United States, 08690
United States, New York
GTx Investigative Site
Albany, New York, United States, 12208
GTx Investigative Site
Oneida, New York, United States, 13421
GTx Investigative Site
Syracuse, New York, United States, 13210
United States, North Carolina
GTx Investigative Site
Concord, North Carolina, United States, 28025
United States, Ohio
GTx Investigative Site
Cincinnati, Ohio, United States, 45212
GTx Investigative Site
Columbus, Ohio, United States, 43220
United States, Pennsylvania
GTx Investigative Site
Bala Cynwyd, Pennsylvania, United States, 19004
Sponsors and Collaborators
GTx
Investigators
Study Director: Mitchell Steiner, MD GTx
  More Information

No publications provided

Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT01393119     History of Changes
Other Study ID Numbers: G200710
Study First Received: July 11, 2011
Last Updated: April 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014