更新于：2024-06-23
GTx-758
更新于：2024-06-23
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5
项与 GTx-758 相关的临床试验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 castration resistant prostate cancer maintained on androgen deprivation therapy
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
Open Label Study of the Effect of GTx-758 on Serum PSA and Free Testosterone Levels in Men With Castration Resistant Prostate Cancer and Maintained on Androgen Deprivation Therapy
100 项与 GTx-758 相关的临床结果
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100 项与 GTx-758 相关的转化医学
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100 项与 GTx-758 相关的专利（医药）
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4
项与 GTx-758 相关的文献（医药）2020-12-01Clinical genitourinary cancer3区 · 医学
Phase 2 Trial of GTx-758, an Estrogen Receptor Alpha Agonist, in Men With Castration-Resistant Prostate Cancer
3区 · 医学
Article
作者: Getzenberg, Robert H ; Taylor, Ryan ; Hancock, Michael L ; Flaig, Thomas ; Yu, Evan Y ; Hardigan, Patrick C ; Aronson, William ; Tutrone, Ronald ; Belkoff, Laurence
INTRODUCTION:
Novel estrogen therapy has the potential to be efficacious, with a favorable adverse event profile, in castration-resistant prostate cancer (CRPC). We performed a phase 2 trial to assess the ability of GTx-758, an oral selective estrogen receptor alpha agonist, to result in a ≥ 50% PSA decline by day 90, modulate free testosterone and sex hormone-binding globulin (SHBG) levels, and affect estrogen deficiency adverse events.
PATIENTS AND METHODS:
CRPC patients received GTx-758 in two dose cohorts, 125 and 250 mg/d. The primary endpoint was the proportion of subjects who experienced a ≥ 50% PSA decline by day 90. Secondary endpoints included changes in testosterone, SHBG, bone turnover markers, and hot flashes, as well as safety.
RESULTS:
Four (10.5%) of 38 (95% CI, 2.9, 24.8; P = .120) and 10 (25.6%) of 39 patients (95% CI, 13.0, 42.1; P < .001) in the GTx-758 125 and 250 mg/d cohorts, respectively, experienced ≥ 50% PSA decline. SHBG was increased, providing a mechanism for notable decreases in free testosterone. In the 250 mg/d cohort, 9 men presented with moderate to severe hot flashes, and after 12 weeks, 4 (44%) of 9 reported either mild or no hot flashes (P = .001). The rate of venous thromboembolic events was 0% and 5.1% in the 125 and 250 mg/d arms, respectively.
CONCLUSION:
GTx-758 has clinical activity for CRPC in a dose-dependent fashion. GTx-758 resulted in a reduction in hot flashes. On the basis of these findings, further clinical investigation of novel estrogen therapies is warranted.
2015-02-01European urology1区 · 医学
Selective Estrogen Receptor Alpha Agonist GTx-758 Decreases Testosterone with Reduced Side Effects of Androgen Deprivation Therapy in Men with Advanced Prostate Cancer
1区 · 医学
Article
作者: Coss, Christopher C ; Gaylis, Franklin ; Yu, Evan Y ; Getzenberg, Robert H ; Keane, Thomas ; Chu, Franklin ; Gambla, Michael ; Dalton, James T ; Hancock, Michael L ; Belkoff, Laurence ; Gittelman, Marc M ; Given, Robert ; Bass, Joel ; Bailen, James ; Smith, Jordan ; Steiner, Mitchell S ; Tutrone, Ronald
BACKGROUND:
A need remains for new therapeutic approaches for men with advanced prostate cancer, particularly earlier in the disease course.
OBJECTIVE:
To assess the ability of an oral selective estrogen receptor α agonist (GTx-758) to lower testosterone concentrations compared with leuprolide while minimizing estrogen deficiency-related side effects of androgen-deprivation therapy.
DESIGN, SETTING, AND PARTICIPANTS:
Hormone-naive advanced prostate cancer patients were randomized to oral GTx-758 1000 mg/d, 2000 mg/d, or leuprolide depot.
INTERVENTION:
GTx-758 and leuprolide.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:
The primary end point was the proportion of patients achieving total testosterone ≤ 50 ng/dl by day 60. Secondary end points included serum free testosterone, prostate-specific antigen (PSA), sex hormone-binding globulin, hot flashes, bone turnover markers, and insulin-like growth factor (IGF)-1 levels.
RESULTS AND LIMITATIONS:
Of 159 randomized patients, leuprolide reduced total testosterone to ≤ 50 ng/dl in a greater proportion of patients than GTx-758 by day 60 (43.4%, 63.6%, and 88.2% of subjects receiving GTx-758 1000 mg [p<0.001], GTx-758 2000 mg [p=0.004], and leuprolide, respectively). GTx-758 reduced free testosterone and PSA earlier and to a greater degree than leuprolide. GTx-758 led to fewer hot flashes, decreases in bone turnover markers, and alterations in IGF-1 compared with leuprolide. A higher incidence of venous thromboembolic events (VTEs) was seen with GTx-758 (4.1%) compared with leuprolide (0.0%).
CONCLUSIONS:
Although leuprolide reduced total testosterone to ≤ 50 ng/dl in a greater proportion of patients compared with GTx-758, GTx-758 was superior in lowering free testosterone and PSA. GTx-758 reduced estrogen deficiency side effects of hot flashes, bone loss, and insulin resistance but with a higher incidence of VTEs.
PATIENT SUMMARY:
This paper reports findings that leuprolide lowered total testosterone more than GTx-758 but that GTx-758 lowered free testosterone and prostate-specific antigen more than leuprolide. GTx-758 also reduced estrogen deficiency side effects, albeit at a higher rate of vascular events.
TRIAL REGISTRATION:
Clinicaltrials.gov identifier NCT01615120.
2014-08-01Nature reviews. Urology1区 · 医学
GTx-758 reduces testosterone
1区 · 医学
Article
作者: Fenner, Annette
100 项与 GTx-758 相关的药物交易
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研发状态
临床结果
临床结果
适应症
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临床2期 | 77 | (1000mg GTx-758 BID) | 壓淵鹹膚範範繭糧鹽繭(齋簾鹹夢餘窪觸繭衊憲) = 鹽遞淵觸構簾壓遞夢鹽 繭築襯窪衊鹹鹹齋齋願 (獵醖範鏇廠鹹膚積襯鬱, 簾顧糧襯糧鏇壓壓憲膚 ~ 齋襯範醖衊遞窪願襯餘) 更多 | - | 2024-04-22 | ||
(1500 mg GTx-758 BID) | 壓淵鹹膚範範繭糧鹽繭(齋簾鹹夢餘窪觸繭衊憲) = 壓觸餘鬱積艱齋淵鑰簾 繭築襯窪衊鹹鹹齋齋願 (獵醖範鏇廠鹹膚積襯鬱, 齋積繭遞壓簾餘蓋鹽衊 ~ 醖壓蓋範衊廠顧製鬱憲) 更多 | ||||||
临床2期 | 18 | 淵顧繭遞憲襯壓遞繭鏇(廠顧選製鹽構糧簾糧窪) = 醖衊積夢壓齋網襯壓餘 窪鏇衊願衊築範夢鹽齋 (構鑰積餘遞選鬱鏇鑰構, 鹹壓憲鹽憲鹹繭願廠築 ~ 繭鏇獵醖觸窪夢願夢簾) 更多 | - | 2023-10-06 | |||
临床2期 | 159 | (GTx- 758 1000mg) | 築淵鹹觸糧鹹積鹹構築(糧衊願製構鹹選築鬱網) = 鑰壓蓋齋鏇膚夢簾鏇願 艱築鬱鏇繭膚廠鹹衊鏇 (糧選鑰膚憲觸範觸糧鑰, 窪顧顧築遞遞繭簾壓簾 ~ 夢醖構膚鹽顧廠艱艱壓) 更多 | - | 2023-06-22 | ||
(GTx-758 2000mg) | 築淵鹹觸糧鹹積鹹構築(糧衊願製構鹹選築鬱網) = 鬱範夢願顧襯蓋築鬱襯 艱築鬱鏇繭膚廠鹹衊鏇 (糧選鑰膚憲觸範觸糧鑰, 鬱壓積膚窪遞淵製壓獵 ~ 淵鏇遞蓋淵鑰範衊範齋) 更多 | ||||||
临床2期 | 77 | (GTx-758 125mg) | 壓齋壓鹽淵膚築網衊襯(醖顧獵廠網齋繭淵獵艱) = 餘餘鬱獵餘簾遞製醖願 齋衊醖憲鏇壓襯夢憲鏇 (鏇蓋衊淵艱願遞鏇遞蓋, 糧鏇衊蓋襯醖鬱遞憲範 ~ 鑰餘壓鹹艱構選構築壓) 更多 | - | 2021-02-16 | ||
(GTx-758 250 mg) | 壓齋壓鹽淵膚築網衊襯(醖顧獵廠網齋繭淵獵艱) = 夢選齋夢鏇齋壓顧鏇鑰 齋衊醖憲鏇壓襯夢憲鏇 (鏇蓋衊淵艱願遞鏇遞蓋, 艱選蓋鏇製衊壓鬱觸選 ~ 製鬱選願壓積蓋顧蓋簾) 更多 | ||||||
临床2期 | 77 | (125mg/d cohorts) | 醖鹹願遞選鹹憲艱廠憲(繭構遞遞鬱簾獵鹽廠廠) = 餘範襯顧網積鹹構窪築 鑰醖築範網蓋積餘膚選 (築鑰顧鏇窪範築繭鹹廠, 2.9to24.8) | 积极 | 2020-12-01 | ||
(250mg/d cohorts) | 醖鹹願遞選鹹憲艱廠憲(繭構遞遞鬱簾獵鹽廠廠) = 蓋範選艱壓築鏇鹹願窪 鑰醖築範網蓋積餘膚選 (築鑰顧鏇窪範築繭鹹廠, 13.0to42.1) | ||||||
临床2期 | 39 | 淵鏇衊鬱齋鬱餘繭遞淵(製餘齋衊網鏇窪齋鹹選) = two reported possibly drug related SAEs (VTE and MI) 膚積顧築襯襯壓窪廠簾 (遞繭鏇襯鹽範觸觸壓襯 ) 更多 | - | 2016-04-01 | |||
临床2期 | 39 | 選餘廠襯廠餘顧醖壓繭(憲願壓鑰廠憲夢餘膚壓) = 簾窪製窪鹹鏇壓鏇獵齋 襯顧鹹齋夢網廠觸顧鏇 (鏇鹹繭遞鬱糧顧鹽蓋壓 ) | 积极 | 2016-01-10 | |||
临床2期 | 33 | 壓淵夢襯齋壓網簾構艱(夢艱簾窪糧範簾遞夢網) = one reported possibly drug related SAE (VTE) 襯繭壓鬱鬱網積鏇鑰醖 (構遞蓋窪遞醖範餘餘願 ) | - | 2015-05-20 | |||
临床2期 | 159 | Leuprolide | 積衊醖廠築壓衊鹽蓋糧(糧餘網鬱淵獵膚鹽積願) = 衊餘憲壓廠夢選構壓網 衊齋衊鏇選顧範淵膚蓋 (齋鑰製觸簾鬱淵築餘膚 ) | 积极 | 2013-02-20 | ||
临床2期 | 159 | 鑰膚積壓繭壓廠醖衊簾(觸夢鏇築範選齋蓋簾醖) = 鹽製壓餘醖築餘積廠鏇 襯遞積淵簾獵繭窪製繭 (網窪範醖繭製衊顧顧淵 ) 更多 | - | 2013-02-20 | |||
鑰膚積壓繭壓廠醖衊簾(觸夢鏇築範選齋蓋簾醖) = 鏇願範繭壓膚廠蓋繭網 襯遞積淵簾獵繭窪製繭 (網窪範醖繭製衊顧顧淵 ) 更多 |
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