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Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer

Information source: GTx
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: GTx-758 (Drug); Lupron Depot (Drug); GTx-758 (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: GTx

Official(s) and/or principal investigator(s):
Mitchell Steiner, MD, Study Director, Affiliation: GTx

Summary

The purpose of this study is to determine whether GTx 758 is effective in achieving and maintaining castrate testosterone levels in men with advanced prostate cancer.

Clinical Details

Official title: Phase II, Open Label, Dose Finding Study of the Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer Compared to a Luteinizing Hormone Releasing Hormone Agonist

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To determine the proportion of men who are castrate by Day 60 in those taking GTx 758 compared to those taking Lupron Depot.

Secondary outcome:

To determine the proportion of men who are castrate by Day 60 and are maintained in the castrate range from Day 60 to Day 360/end of study.

To determine the time to castration in men with prostate cancer treated with GTx-758

The change from baseline to Day 60 in free testosterone in GTx-758 treatment group compared to the Lupron treatment group will be assessed.

Detailed description: Prostate cancer is one of the most frequently diagnosed noncutaneous cancers among men in the US and is the second most common cause of cancer deaths. Patients with advanced prostate cancer undergo androgen deprivation therapy (ADT), by either LHRH agonists, LHRH antagonists, DES and other nonselective estrogens, or by bilateral orchiectomy. ADT by LHRH agonists, LHRH antagonists, or bilateral orchiectomy not only reduces testosterone, but also substantially lowers estrogen levels as estrogen is derived from the aromatization of testosterone. ADT-induced estrogen deficiency causes significant side effects which include hot flushes, gynecomastia, bone loss, decreases in bone quality and strength, osteoporosis and life-threatening fractures, adverse lipid changes, increase in body fat composition, and higher cardiovascular disease and myocardial infarction, and depression and other mood changes. GTx-758 is a nonsteroidal selective ER agonist that suppresses LH secretion by the pituitary by feedback inhibition of the hypothalamic-pituitary-gonadal axis to induce castrate levels of testosterone. However, because it is a selective ER agonist, GTx-758 may maintain bone, does not induce hot flushes, avoids adverse lipid changes and body fat composition changes, and does not have the acute testosterone surge that are associated with other forms of ADT.

Eligibility

Minimum age: 45 Years. Maximum age: 80 Years. Gender(s): Male.

Criteria:

Inclusion Criteria: 1. be between age 45 and 80 years of age 2. be able to communicate effectively with study personnel 3. ECOG is < or = 2 4. screening serum total testosterone> or = 150ng/dL 5. have prostate cancer, confirmed by pathology report 6. have not been treated with androgen deprivation therapy(chemical or surgical 7. have a clinical indication for the initiation of androgen deprivation therapy 8. give written informed consent prior to any study specific procedures 9. subject must agree to use acceptable methods of contraception Exclusion Criteria: 1. known hypersensitivity or allergy to estrogen or estrogen like drugs 2. 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 4. have ALT or AST above 2 times the upper normal limit 5. have alkaline phosphatase greater than 3 times UNL and/or bilirubin levels above 2mg/dL at baseline 6. patients cannot have brain or spinal cord metastases 7. patients cannot have or be at 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 within 4 weeks of 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 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 480msec two additional ECGs are to be performed separated at least 5 min apart, then take the average of the three QTcB or readings to determine if the subject satisfies the above criteria. If the average QYcB reading is >480 msec then the subject is excluded.

Locations and Contacts

GTx Investigative Site, Phoenix, Arizona 85032, United States

GTx Investigative Site, La Mesa, California 91942, United States

GTx Investigative Site, Los Angeles, California 90048, United States

GTx Investigative Site, San Bernardino, California 92404, United States

GTx Investigative Site, Middlebury, Connecticut 06762, United States

GTx Investigative Site, Aventura, Florida 33180, United States

GTx Investigative Site, Daytona Beach, Florida 32114, United States

GTx Investigative Site, Wellington, Florida 33449, United States

GTx Investigative Site, Marietta, Georgia 30060, United States

GTx Investigative Site, Springfield, Illinois 62703, United States

GTx Investigative Site, Fort Wayne, Indiana 46825, United States

GTx Investigative Site, Indianapolis, Indiana 46260, United States

GTx Investigative Site, Jeffersonville, Indiana 47130, United States

GTx Investigative Site, Annapolis, Maryland 21401, United States

GTx Investigative Site, Baltimore, Maryland 21204, United States

GTx Investigative Site, Brick, New Jersey 08724, United States

GTx Investigative Site, Lawrenceville, New Jersey 08648, United States

GTx Investigative Site, Albuquerque, New Mexico 87109, United States

GTx Investigative Site, Albany, New York 12208, United States

GTx Investigative Site, Garden City, New York 11530, United States

GTx Investigative Site, New York City, New York 10016, United States

GTx Investigative Site, Oneida, New York 13421, United States

GTx Investigative Site, Syracuse, New York 13210, United States

GTx Investigative Site, Chapel Hill, North Carolina 27514, United States

GTx Investigative Site, Raleigh, North Carolina 27607, United States

GTx Investigative Site, Cincinnati, Ohio 45212, United States

GTx Investigative Site, Columbus, Ohio 43220, United States

GTx Investigative Site, Bala Cynwyd, Pennsylvania 19004, United States

GTx Investigative Site, Lancaster, Pennsylvania 17606, United States

GTx Investigative Site, Pittsburgh, Pennsylvania 15232, United States

GTx Investigative Site, Myrtle Beach, South Carolina 29572, United States

GTx Investigative Site, Memphis, Tennessee 38117, United States

GTx Investigative Site, Nashville, Tennessee 37209, United States

GTx Investigative Site, Arlington, Texas 76017, United States

GTx Investigative Site, Houston, Texas 77030, United States

GTx Investigative Site, San Antonio, Texas 78229, United States

Additional Information

Starting date: June 2011
Last updated: April 23, 2014

Page last updated: August 23, 2015

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