Prostate CancerPhase 2NCT01393119
Phase II, Dose Finding Study of GTx-758
A Phase 2 study testing GTx-758 in people with Prostate Cancer, run by GTx at 21 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- GTx-758
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 21 sitesUnited States
- Study dates
- Aug 2011to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between age 45 and 80 years of age
- Be able to communicate effectively with the study personnel
- ECOG is ≤2
- Screening serum total testosterone ≥150 ng/dL
- Have prostate cancer, confirmed by pathology report
- 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.
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- Have a clinical indication for the initiation ADT.
- Give written informed consent prior to any study specific procedures
- 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.
Who cannot join
- Known hypersensitivity or allergy to estrogen or estrogen like drugs
- 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
- 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.
- Have ALT or AST above 2 times the upper limit of normal (ULN)
- Have alkaline phosphatase greater than 3 times ULN and/or total bilirubin levels above 2 mg/dL at baseline
- Patients cannot have brain or spinal cord metastases
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- Patients cannot have or be at high risk for spinal cord compression from bone metastases.
- Received an investigational drug within a period of 90 days prior to enrollment in the study
- Received the study medication previously
- 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)
- Currently taking Saw Palmetto or PC-SPES (the subject may be considered for randomization after a 4 week washout period prior to randomization)
- Have taken diethylstilbestrol or other estrogen products within the previous 12 months prior to randomization into this study
- Have taken body building or fertility supplements within 4 weeks of admission into the study (steroids and steroid like supplements)
- 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.
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
GTx Investigative Site
Albany, New York, 12208
GTx Investigative Site
Annapolis, Maryland, 21401
GTx Investigative Site
Aventura, Florida, 33180
GTx Investigative Site
Bala-Cynwyd, Pennsylvania, 19004
GTx Investigative Site
Bradenton, Florida, 34205
GTx Investigative Site
Cincinnati, Ohio, 45212
GTx Investigative Site
Columbus, Ohio, 43220
GTx Investigative Site
Concord, North Carolina, 28025
GTx Investigative Site
Glendale, Arizona, 85306
GTx Investigative Site
Hamilton, New Jersey, 08690
GTx Investigative Site
Jeffersonville, Indiana, 47130
GTx Investigative Site
La Mesa, California, 91942
GTx Investigative Site
Oneida, New York, 13421
GTx Investigative Site
Phoenix, Arizona, 85032
GTx Investigative Site
Roswell, Georgia, 30076
GTx Investigative Site
San Bernardino, California, 92404
GTx Investigative Site
Shreveport, Louisiana, 71106
GTx Investigative Site
St. Petersburg, Florida, 33710
GTx Investigative Site
Syracuse, New York, 13210
GTx Investigative Site
Tampa, Florida, 33607
GTx Investigative Site
Towson, Maryland, 21204
About this study
Official title: Phase II, Open-label, Loading and Maintenance Dose Finding Study of GTx-758 in Men With Prostate Cancer
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.
Read the detailed description
The original purpose of the study was to determine the appropriate loading and maintenance dose of GTx-758 to reach and maintain castration for the duration of the study. The primary endpoint was used to assess the loading dose, while the secondary endpoint was intended to be used to assess maintenance. Due to the study being terminated early, as requested by FDA, the secondary assessment of maintenance was unable to be assessed. Hence, all summaries provided are for subjects in the two loading dose groups of 1000 mg BID and 1500mg BID only and not broken out by the maintenance dose.
- Conditions
- Prostate Cancer
- Being tested
- GTx-758
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTx-758Drug
3-fluoro-N-( 4-fluorophenyl)-4-hydroxy-N-( 4-hydroxyphenyl) benzamide; a nonsteroidal selective estrogen receptor (ER) a agonist
| Study group | Role | What they receive |
|---|---|---|
| 1000mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg | Experimental | 1000mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg Receives: Drug: GTx-758 |
| 1000mg Loading DoseGTx-758 BID and Maintenance Dose 2000mg | Experimental | 1000mg Loading Dose GTx-758 BID and Maintenance Dose 2000mg Receives: Drug: GTx-758 |
| 1500 mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg | Experimental | 1500 mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg Receives: Drug: GTx-758 |
| 1500 mg Loading Dose GTx-758 BID and Maintenance Dose 2000mg | Experimental | 1500 mg Loading Dose GTx-758 BID and Maintenance Dose 2000mg Receives: Drug: GTx-758 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects That Reach Castration by Day 28
Percentage of Patients Note: Due to the study being terminated early, per FDA, the secondary assessment of maintenance was unable to be assessed. Hence, all summaries provided are for subjects in the two loading dose groups of 1000 mg BID and 1500mg BID only.
PLEASE NOTE: Study was terminated early, per FDA, the secondary assessment of maintenance was unable to be assessed. Hence, the efficacy summary provided are for subjects in the two loading dose groups of 1000 mg BID and 1500mg BID only, poling across maintenance doses within each loading dose.
Safety/ITT - 27 and 28 patients, respectively mITT - 18 and 19 patients, respectively Note: mITT includes patients that meet the requirements for the efficacy analyses
This format was agreed to by the PRS review team, per email communication on guidnace for presenting the data.
Measured: Day 1-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: FDA Clinical Hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- GTx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell Steiner, MD, Study director, GTx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393119
- Sponsor's protocol ID
- G200710
- Status last verified
- Mar 2024
- First submitted
- 11 Jul 2011
- Last updated
- 22 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open-label, Loading and Maintenance Dose Finding Study of GTx-758 in Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT01393119
- Acronym / sponsor ID
- G200710
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA Clinical Hold
- Enrolment
- 77 participants (actual)
- Lead sponsor
- GTxIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Posted 22 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The original purpose of the study was to determine the appropriate loading and maintenance dose of GTx-758 to reach and maintain castration for the duration of the study. The primary endpoint was used to assess the loading dose, while the secondary endpoint was intended to be used to assess maintenance. Due to the study being terminated early, as requested by FDA, the secondary assessment of maintenance was unable to be assessed. Hence, all summaries provided are for subjects in the two loading dose groups of 1000 mg BID and 1500mg BID only and not broken out by the maintenance dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1000mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg | Experimental | Drug: GTx-7581000mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg |
| 1000mg Loading DoseGTx-758 BID and Maintenance Dose 2000mg | Experimental | Drug: GTx-7581000mg Loading Dose GTx-758 BID and Maintenance Dose 2000mg |
| 1500 mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg | Experimental | Drug: GTx-7581500 mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg |
| 1500 mg Loading Dose GTx-758 BID and Maintenance Dose 2000mg | Experimental | Drug: GTx-7581500 mg Loading Dose GTx-758 BID and Maintenance Dose 2000mg |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be between age 45 and 80 years of age
- Be able to communicate effectively with the study personnel
- ECOG is ≤2
- Screening serum total testosterone ≥150 ng/dL
- Have prostate cancer, confirmed by pathology report
Key exclusion criteria (15 listed)
- Known hypersensitivity or allergy to estrogen or estrogen like drugs
- 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
- 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.
- Have ALT or AST above 2 times the upper limit of normal (ULN)
- Have alkaline phosphatase greater than 3 times ULN and/or total bilirubin levels above 2 mg/dL at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTx-7583-fluoro-N-( 4-fluorophenyl)-4-hydroxy-N-( 4-hydroxyphenyl) benzamide; a nonsteroidal selective estrogen receptor (ER) a agonist | Drug | 1000mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg, 1000mg Loading DoseGTx-758 BID and Maintenance Dose 2000mg, 1500 mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg, 1500 mg Loading Dose GTx-758 BID and Maintenance Dose 2000mg |
Primary outcome
Percentage of Subjects That Reach Castration by Day 28
Time frame: Day 1-28
Percentage of Patients Note: Due to the study being terminated early, per FDA, the secondary assessment of maintenance was unable to be assessed. Hence, all summaries provided are for subjects in the two loading dose groups of 1000 mg BID and 1500mg BID only. PLEASE NOTE: Study was terminated early, per FDA, the secondary assessment of maintenance was unable to be assessed. Hence, the efficacy summary provided are for subjects in the two loading dose groups of 1000 mg BID and 1500mg BID only, poling across maintenance doses within each loading dose. Safety/ITT - 27 and 28 patients, respectively mITT - 18 and 19 patients, respectively Note: mITT includes patients that meet the requirements for the efficacy analyses This format was agreed to by the PRS review team, per email communication on guidnace for presenting the data.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Steiner, MD study director
GTx
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GTx-758 in people with Prostate Cancer, run by GTx at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects That Reach Castration by Day 28 (time frame: Day 1-28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024; AzTrials last refreshed its copy on 1 Nov 2026.