Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by GTx
Sponsor:
Information provided by (Responsible Party):
GTx
ClinicalTrials.gov Identifier:
NCT01615120
First received: June 6, 2012
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

Protocol G200712 is a Phase II, exploratory study to assess the effects of GTx-758 on serum prostate specific antigen (PSA) response ans serum PSA progression in men with Metastatic Castration Resistant Prostate Cancer (mCRPC) on Androgen Deprivation Therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or orchidectomy. This study will also assess the venous thromboembolism (VTE) risk of lower doses of GTx-758.


Condition Intervention Phase
Prostate Cancer
Drug: GTx-758 125 mg
Drug: GTx-758 250 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II, Open Label Study of the Effect of GTx-758 as Secondary Hormonal Therapy on Serum PSA and Serum Free Testosterone Levels in Men With Metastatic Castration Resistant Prostate Cancer Maintained on Androgen Deprivation Therapy

Resource links provided by NLM:


Further study details as provided by GTx:

Primary Outcome Measures:
  • Decline in Serum PSA [ Time Frame: 120 days ] [ Designated as safety issue: No ]
    The proportion of subjects with a 50% decline from baseline in serum PSA (confirmed by a second serum PSA assessment 30 days later) by Day 90 (with follow up confirmation by Day 120)


Estimated Enrollment: 76
Study Start Date: July 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GTx-758 125mg
one GTx-758 tablet orally administered daily
Drug: GTx-758 125 mg
One 125 mg tablet once a day
Experimental: GTx-758 250 mg
two GTx-758 tablets orally administered daily
Drug: GTx-758 250 mg
two 125 mg tablets once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be over age 18 years
  • Be able to Communicate effectively with the study personnel
  • Have histologically confirmed prostate cancer
  • Have castration resistant prostate cancer patients with radiographic evidence of metastatic disease (T any - N any - MI)
  • ECOG performance status of 0 to 2
  • Have been treated with ADT (chemical or surgical) for at least 6 months
  • Have a castrate level of serum total testosterone (< 50ng/dL)
  • Have a history of serum PSA response on ADT. A serum PSA response is an undetectable level of serum PSA (≤ 0.2/mL) or at least a 90% reduction in serum PSA from the serum PSA value prior to the initiation of treatment to < 10ng/mL
  • Have a rising serum PSA on two successive assessments at least 2 weeks apart and serum PSA levels ≥ 2ng/mL or > 2 ng/mL and a 25% increase above the nadir from the ADT.
  • Be continued on ADT throughout this study
  • give written informed consent prior to any study specific procedures
  • subjects must agree, if not already on anticoagulation therapy or aspirin, to take 81 mg aspirin daily throughout the duration of their participation in this study and for 30 days after completion of dosing with GTx-758.
  • 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/fil/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 with spermicidal foam/gel/film/cream/suppository} should be used
  • If the female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method {condom with spermicidal foam/gel/film/cream/suppository} should also be used.

Exclusion Criteria:

  • Known hypersensitivity or allergy to estrogen or estrogen like drugs
  • Need for urgent chemotherapy, radiation therapy or surgical intervention for prostate cancer in the opinion of the investigator;
  • 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
  • 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)).
  • Any subjects, as determined by a central laboratory, with

    1. a modified activated protein C reaction ratio ≤ 2.5 and a Factor V Leiden gene mutation,
    2. an antithrombin level below the lower limit of the normal range,
    3. an antiphospholipid antibody level that is indeterminate, positive, or outside the normal range,
    4. or a prothrombin gene mutation
  • Symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris, cardiac arrhythmia, or history of atrial fibrillation
  • The presence of consistently abnormal laboratory values which are considered clinically significant. In addition, any subject with liver enzymes (ALT or AST) above 2 times the upper limit of normal, total bilirubin above 2 times the upper limit of normal, or serum creatinine above 1.5 times the upper limit of normal will NOT be admitted to the study.
  • Received an investigational drug within a period of 90 days prior to the enrollment in the study.
  • Received the study medication GTx-758 previously;
  • Currently taking testosterone, testosterone like agents, 5a-reductase inhibitor (finasteride, dutasteride),or antiandrogens (bicalutamide, flutamide or nilutamide). Subjects taking a 5a-reductase inhibitor or one of these antiandrogens may be eligible if the subject undergoes a 6 week washout period after stopping therapy. The subject must have at least two rising serum PSA levels at least 2 weeks apart after therapy with these 5a-reductase inhibitor or these antiandrogens have been stopped (antiandrogen withdrawal)and complete the 6-week washout period to be eligible;
  • Have previously taken or are currently taking diethylstilbestrol, other estrogens, abiraterone or ketoconazole or any other inhibitor of CYP17 (17a-hydroxylase/C17,20-lyase);
  • Currently having radiation therapy to prostate for cancer control (radiation to bone to relieve pain is acceptable)
  • Have previously taken or are currently taking enzalutamide;
  • Have previously received cytotoxic chemotherapy for prostate cancer;
  • Recent hospitalization (within 30 days of screening);
  • Recent surgery (within 30 days of screening);
  • Have taken body building or fertility supplements within 4 weeks of admission into the study;
  • Have been previously diagnosed or treated for active cancer (other than prostate cancer or non-melanoma skin cancer)within the previous five years;
  • Have a BMI > 35.
  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: NCT01615120

Contacts
Contact: Michael DeSordi, MBA 901-523-9700 mdesordi@gtxinc.com

  Show 26 Study Locations
Sponsors and Collaborators
GTx
  More Information

No publications provided

Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT01615120     History of Changes
Other Study ID Numbers: G200712
Study First Received: June 6, 2012
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 14, 2014