Number of Participants Who Are Castrate by Day 60
| Group | Value (participants) |
|---|---|
| GTx- 758 1000mg | 19 |
| GTx-758 2000mg | 34 |
| Lupron Depot | 43 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataShort name GTx758
This trial was stopped early.
Reason given at the registry: FDA Clinical Hold
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
GTx- 758 1000mg
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
Experimental
GTx-758 2000mg
GTx-758/Experimental/ nonsteroidal selective ER alpha agonist
Active comparator
Lupron Depot
Luteinizing Hormone Releasing Hormone Agonist
Outcomes the sponsor listed as primary.
Number of Participants Who Are Castrate by Day 60
Time frame · 60 days
Number of Participants Who Are Castrate by Day 60 and Maintained Castrate Range From Day 60 to Day 360/End of Study.
Time frame · 12 months
Time to Castration in Participants With Prostate Cancer
Time frame · 60 days
Median time to castration was summarized using the Kaplan-Meier method.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| GTx- 758 1000mg | 19 |
| GTx-758 2000mg | 34 |
| Lupron Depot | 43 |
| Group | Value (Participants) |
|---|---|
| GTx- 758 1000mg | 0 |
| GTx-758 2000mg | 3 |
| Lupron Depot | 9 |
| Group | Value (days) |
|---|---|
| GTx-758 1000mg | 29 |
| GTx-758 2000mg | 21 |
| Lupron Depot | 21 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| GTx- 758 1000mgGTx-758/Experimental/ nonsteroidal selective ER alpha agonist GTx-758 2000mg: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension | 1 / 53 | 11 / 53 | 46 / 53 |
| GTx-758 2000mgGTx-758/Experimental/ nonsteroidal selective ER alpha agonist GTx-758 1000mg: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension | 0 / 55 | 6 / 55 | 49 / 55 |
| Lupron DepotLuteinizing Hormone Releasing Hormone Agonist Lupron Depot: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension | 1 / 51 | 4 / 51 | 48 / 51 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
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Who could join, as posted.
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