The Experts below are selected from a list of 54 Experts worldwide ranked by ideXlab platform
Marc B Garnick - One of the best experts on this subject based on the ideXlab platform.
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Abarelix for injectable suspension first in class gonadotropin releasing hormone antagonist for prostate cancer
Future Oncology, 2006Co-Authors: F M J Debruyne, Gajanan Bhat, Marc B GarnickAbstract:Abarelix, a gonadotropin-releasing hormone antagonist, with its indication for advanced symptomatic prostate cancer, represents the newest category of hormonal therapy introduced in the past 15 years. Results from Phase II and III clinical trials demonstrate the advantages of Abarelix over commonly used luteinizing hormone-releasing hormone (LHRH) agonist therapy: Abarelix does not cause a surge in serum testosterone that can precipitate a flare phenomenon or worsening of disease, particularly dangerous for patients with metastatic, symptomatic disease, and produces medical castration more quickly. Abarelix was also demonstrated to promptly and substantially reduce follicle-stimulating hormone levels to lower than LHRH agonist. Study results demonstrate effective anticancer responses during extended exposure to Abarelix: improvements in pain score and/or analgesic use, improvements in urinary symptoms (including urinary catheter removal) and complete avoidance of bilateral orchiectomy for patients undergo...
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the effect of hormonal therapy for prostate cancer on the electrocardiographic qt interval phase 3 results following treatment with leuprolide and goserelin alone or with bicalutamide and the gnrh antagonist Abarelix
Journal of Clinical Oncology, 2004Co-Authors: Marc B Garnick, Marilyn Campion, C Pratt, J ShipleyAbstract:4578 Background: The electrocardiographic QT interval measures ventricular repolarization, and, if prolonged, may predispose to arrhythmias and sudden death. Preclinically, testosterone (T) deficiency may prolong the QT interval. However, the effect of hormone treatments (HTs) for prostate cancer which induce androgen deficiency (AD) has not been well studied. Methods: Three randomized Phase III studies were conducted that compared the GnRH antagonist Abarelix to either goserelin plus bicalutamide (G+B) (Study 1); leuprolide (L) monotherapy (Study 2; Urology 58:756, 2001); or L plus B (L+B) (Study 3; J. Urol 167:1670, 2002) in patients (pts) with prostate cancer undergoing initial HT and included pts with Stage D1/D2 disease, rising PSA, intermittent HT or neoadjuvant HT. Study 1 prospectively evaluated data from 177 pts; Studies 2 and 3 retrospectively evaluated 299 of 520 treated pts. Barzett and Fredericia QT intervals (QTcB, QTcF) were measured at baseline (BL), days(D) 84 and 336 of treatment in Stud...
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a phase 3 multicenter open label randomized study of Abarelix versus leuprolide plus daily antiandrogen in men with prostate cancer
The Journal of Urology, 2002Co-Authors: John Trachtenberg, Marilyn Campion, Nick Fotheringham, Marc Gittleman, Christopher P Steidle, Winston E Barzell, William Friedel, Dennis Pessis, Marc B GarnickAbstract:Purpose: We compared the endocrinological and biochemical efficacy of Abarelix depot, a gonadotropin-releasing hormone antagonist, with that of a widely used combination of luteinizing hormone releasing hormone agonist and a nonsteroidal antiandrogen.Materials and Methods: A total of 255 patients were randomized to receive open label 100 mg. Abarelix depot or 7.5 mg. leuprolide acetate intramuscularly injection on days 1, 29, 57, 85, 113 and 141 for 24 weeks. Patients in the Abarelix group received an additional injection on day 15 and those in the leuprolide acetate group received 50 mg. bicalutamide daily. Patients could continue treatment with study drug for an additional 28 weeks. The efficacy end points were the comparative rates of avoidance of testosterone surge (greater than 10% increase) within 7 days of the first injection and the rapidity of achieving reduction of serum testosterone to castrate levels (50 ng./dl. or less) on day 8. Patients were monitored for adverse events and laboratory abnor...
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a phase 3 multicenter open label randomized study of Abarelix versus leuprolide acetate in men with prostate cancer
Urology, 2001Co-Authors: David G Mcleod, Kevin M Tomera, Norman Zinner, Marilyn Campion, Donald F Gleason, Nick Fotheringham, Marc B GarnickAbstract:Objectives. To evaluate the levels of testosterone and other hormones in men with prostate cancer treated with Abarelix versus leuprolide acetate. Methods. Patients (n = 269) were randomized to receive open-label Abarelix 100 mg or leuprolide acetate 7.5 mg by intramuscular injection. The results of the first 84 days of the study are reported. The primary efficacy endpoints included avoidance of testosterone surge, castration on day 8, and achievement and maintenance of castration from days 29 through 85. The secondary endpoints included castration on days 2, 4, and 15; a reduction in prostate-specific antigen level; and measurements of other hormones. Patients were monitored for clinical adverse events and laboratory abnormalities. Results. No men in the Abarelix group and 82% of men in the leuprolide acetate group experienced a testosterone surge (P <0.001). Abarelix caused rapid medical castration: 24% of men 1 day after treatment and 78% after 7 days compared with 0% of men treated with leuprolide acetate on either day. A comparable percentage of men achieved and maintained castration between days 29 and 85 in each group. Prostate-specific antigen had a statistically significant decrease for the first month in patients treated with Abarelix. Dihydrotestosterone, luteinizing hormone, prostate-specific antigen, and follicle-stimulating hormone showed similar rapid reductions without an initial increase. The overall occurrence of adverse events was similar across the treatment groups, and most were sequelae of comorbid disorders. Conclusions. Treatment with Abarelix produced a higher percentage of patients who avoided a testosterone surge and had a more rapid time to testosterone suppression with a higher rate of medical castration 1 day after treatment and greater reductions in testosterone, luteinizing hormone, follicle-stimulating hormone, and dihydrotestosterone during the first 2 weeks of treatment compared with leuprolide acetate. The achievement and maintenance of castration was comparable between the two groups.
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the gonadotropin releasing hormone antagonist Abarelix depot versus luteinizing hormone releasing hormone agonists leuprolide or goserelin initial results of endocrinological and biochemical efficacies in patients with prostate cancer
The Journal of Urology, 2001Co-Authors: Kevin M Tomera, Donald M Gleason, Marc Gittelman, William Moseley, Norman Zinner, Myron Murdoch, Mani Menon, Marilyn Campion, Marc B GarnickAbstract:Purpose: We contrasted the endocrinological and biochemical efficacies of Abarelix depot, a pure gonadotropin-releasing hormone antagonist, with a prospective concurrent control cohort receiving luteinizing hormone releasing hormone (LH-RH) agonists with or without antiandrogen for treatment of patients with prostate cancer receiving initial hormonal therapy.Materials and Methods: In this phase 2 open label study 242 patients with prostate cancer requiring initial hormonal treatment received Abarelix depot (209) or LH-RH agonists (33) with or without antiandrogen. A total of 100 mg. Abarelix depot was delivered intramuscularly every 28 days with an additional injection on day 15. LH-RH agonists with or without antiandrogen were administered according to the depot formulation used. Endocrine efficacy was measured by the absence of testosterone surge and rapidity of castration onset. The rate of prostate specific antigen decrease was assessed.Results: No patient treated with Abarelix depot had testosterone ...
Marilyn Campion - One of the best experts on this subject based on the ideXlab platform.
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the effect of hormonal therapy for prostate cancer on the electrocardiographic qt interval phase 3 results following treatment with leuprolide and goserelin alone or with bicalutamide and the gnrh antagonist Abarelix
Journal of Clinical Oncology, 2004Co-Authors: Marc B Garnick, Marilyn Campion, C Pratt, J ShipleyAbstract:4578 Background: The electrocardiographic QT interval measures ventricular repolarization, and, if prolonged, may predispose to arrhythmias and sudden death. Preclinically, testosterone (T) deficiency may prolong the QT interval. However, the effect of hormone treatments (HTs) for prostate cancer which induce androgen deficiency (AD) has not been well studied. Methods: Three randomized Phase III studies were conducted that compared the GnRH antagonist Abarelix to either goserelin plus bicalutamide (G+B) (Study 1); leuprolide (L) monotherapy (Study 2; Urology 58:756, 2001); or L plus B (L+B) (Study 3; J. Urol 167:1670, 2002) in patients (pts) with prostate cancer undergoing initial HT and included pts with Stage D1/D2 disease, rising PSA, intermittent HT or neoadjuvant HT. Study 1 prospectively evaluated data from 177 pts; Studies 2 and 3 retrospectively evaluated 299 of 520 treated pts. Barzett and Fredericia QT intervals (QTcB, QTcF) were measured at baseline (BL), days(D) 84 and 336 of treatment in Stud...
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a phase 3 multicenter open label randomized study of Abarelix versus leuprolide plus daily antiandrogen in men with prostate cancer
The Journal of Urology, 2002Co-Authors: John Trachtenberg, Marilyn Campion, Nick Fotheringham, Marc Gittleman, Christopher P Steidle, Winston E Barzell, William Friedel, Dennis Pessis, Marc B GarnickAbstract:Purpose: We compared the endocrinological and biochemical efficacy of Abarelix depot, a gonadotropin-releasing hormone antagonist, with that of a widely used combination of luteinizing hormone releasing hormone agonist and a nonsteroidal antiandrogen.Materials and Methods: A total of 255 patients were randomized to receive open label 100 mg. Abarelix depot or 7.5 mg. leuprolide acetate intramuscularly injection on days 1, 29, 57, 85, 113 and 141 for 24 weeks. Patients in the Abarelix group received an additional injection on day 15 and those in the leuprolide acetate group received 50 mg. bicalutamide daily. Patients could continue treatment with study drug for an additional 28 weeks. The efficacy end points were the comparative rates of avoidance of testosterone surge (greater than 10% increase) within 7 days of the first injection and the rapidity of achieving reduction of serum testosterone to castrate levels (50 ng./dl. or less) on day 8. Patients were monitored for adverse events and laboratory abnor...
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a phase 3 multicenter open label randomized study of Abarelix versus leuprolide acetate in men with prostate cancer
Urology, 2001Co-Authors: David G Mcleod, Kevin M Tomera, Norman Zinner, Marilyn Campion, Donald F Gleason, Nick Fotheringham, Marc B GarnickAbstract:Objectives. To evaluate the levels of testosterone and other hormones in men with prostate cancer treated with Abarelix versus leuprolide acetate. Methods. Patients (n = 269) were randomized to receive open-label Abarelix 100 mg or leuprolide acetate 7.5 mg by intramuscular injection. The results of the first 84 days of the study are reported. The primary efficacy endpoints included avoidance of testosterone surge, castration on day 8, and achievement and maintenance of castration from days 29 through 85. The secondary endpoints included castration on days 2, 4, and 15; a reduction in prostate-specific antigen level; and measurements of other hormones. Patients were monitored for clinical adverse events and laboratory abnormalities. Results. No men in the Abarelix group and 82% of men in the leuprolide acetate group experienced a testosterone surge (P <0.001). Abarelix caused rapid medical castration: 24% of men 1 day after treatment and 78% after 7 days compared with 0% of men treated with leuprolide acetate on either day. A comparable percentage of men achieved and maintained castration between days 29 and 85 in each group. Prostate-specific antigen had a statistically significant decrease for the first month in patients treated with Abarelix. Dihydrotestosterone, luteinizing hormone, prostate-specific antigen, and follicle-stimulating hormone showed similar rapid reductions without an initial increase. The overall occurrence of adverse events was similar across the treatment groups, and most were sequelae of comorbid disorders. Conclusions. Treatment with Abarelix produced a higher percentage of patients who avoided a testosterone surge and had a more rapid time to testosterone suppression with a higher rate of medical castration 1 day after treatment and greater reductions in testosterone, luteinizing hormone, follicle-stimulating hormone, and dihydrotestosterone during the first 2 weeks of treatment compared with leuprolide acetate. The achievement and maintenance of castration was comparable between the two groups.
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the gonadotropin releasing hormone antagonist Abarelix depot versus luteinizing hormone releasing hormone agonists leuprolide or goserelin initial results of endocrinological and biochemical efficacies in patients with prostate cancer
The Journal of Urology, 2001Co-Authors: Kevin M Tomera, Donald M Gleason, Marc Gittelman, William Moseley, Norman Zinner, Myron Murdoch, Mani Menon, Marilyn Campion, Marc B GarnickAbstract:Purpose: We contrasted the endocrinological and biochemical efficacies of Abarelix depot, a pure gonadotropin-releasing hormone antagonist, with a prospective concurrent control cohort receiving luteinizing hormone releasing hormone (LH-RH) agonists with or without antiandrogen for treatment of patients with prostate cancer receiving initial hormonal therapy.Materials and Methods: In this phase 2 open label study 242 patients with prostate cancer requiring initial hormonal treatment received Abarelix depot (209) or LH-RH agonists (33) with or without antiandrogen. A total of 100 mg. Abarelix depot was delivered intramuscularly every 28 days with an additional injection on day 15. LH-RH agonists with or without antiandrogen were administered according to the depot formulation used. Endocrine efficacy was measured by the absence of testosterone surge and rapidity of castration onset. The rate of prostate specific antigen decrease was assessed.Results: No patient treated with Abarelix depot had testosterone ...
Nick Fotheringham - One of the best experts on this subject based on the ideXlab platform.
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a phase 3 multicenter open label randomized study of Abarelix versus leuprolide plus daily antiandrogen in men with prostate cancer
The Journal of Urology, 2002Co-Authors: John Trachtenberg, Marilyn Campion, Nick Fotheringham, Marc Gittleman, Christopher P Steidle, Winston E Barzell, William Friedel, Dennis Pessis, Marc B GarnickAbstract:Purpose: We compared the endocrinological and biochemical efficacy of Abarelix depot, a gonadotropin-releasing hormone antagonist, with that of a widely used combination of luteinizing hormone releasing hormone agonist and a nonsteroidal antiandrogen.Materials and Methods: A total of 255 patients were randomized to receive open label 100 mg. Abarelix depot or 7.5 mg. leuprolide acetate intramuscularly injection on days 1, 29, 57, 85, 113 and 141 for 24 weeks. Patients in the Abarelix group received an additional injection on day 15 and those in the leuprolide acetate group received 50 mg. bicalutamide daily. Patients could continue treatment with study drug for an additional 28 weeks. The efficacy end points were the comparative rates of avoidance of testosterone surge (greater than 10% increase) within 7 days of the first injection and the rapidity of achieving reduction of serum testosterone to castrate levels (50 ng./dl. or less) on day 8. Patients were monitored for adverse events and laboratory abnor...
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a phase 3 multicenter open label randomized study of Abarelix versus leuprolide acetate in men with prostate cancer
Urology, 2001Co-Authors: David G Mcleod, Kevin M Tomera, Norman Zinner, Marilyn Campion, Donald F Gleason, Nick Fotheringham, Marc B GarnickAbstract:Objectives. To evaluate the levels of testosterone and other hormones in men with prostate cancer treated with Abarelix versus leuprolide acetate. Methods. Patients (n = 269) were randomized to receive open-label Abarelix 100 mg or leuprolide acetate 7.5 mg by intramuscular injection. The results of the first 84 days of the study are reported. The primary efficacy endpoints included avoidance of testosterone surge, castration on day 8, and achievement and maintenance of castration from days 29 through 85. The secondary endpoints included castration on days 2, 4, and 15; a reduction in prostate-specific antigen level; and measurements of other hormones. Patients were monitored for clinical adverse events and laboratory abnormalities. Results. No men in the Abarelix group and 82% of men in the leuprolide acetate group experienced a testosterone surge (P <0.001). Abarelix caused rapid medical castration: 24% of men 1 day after treatment and 78% after 7 days compared with 0% of men treated with leuprolide acetate on either day. A comparable percentage of men achieved and maintained castration between days 29 and 85 in each group. Prostate-specific antigen had a statistically significant decrease for the first month in patients treated with Abarelix. Dihydrotestosterone, luteinizing hormone, prostate-specific antigen, and follicle-stimulating hormone showed similar rapid reductions without an initial increase. The overall occurrence of adverse events was similar across the treatment groups, and most were sequelae of comorbid disorders. Conclusions. Treatment with Abarelix produced a higher percentage of patients who avoided a testosterone surge and had a more rapid time to testosterone suppression with a higher rate of medical castration 1 day after treatment and greater reductions in testosterone, luteinizing hormone, follicle-stimulating hormone, and dihydrotestosterone during the first 2 weeks of treatment compared with leuprolide acetate. The achievement and maintenance of castration was comparable between the two groups.
Kevin M Tomera - One of the best experts on this subject based on the ideXlab platform.
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a phase 3 multicenter open label randomized study of Abarelix versus leuprolide acetate in men with prostate cancer
Urology, 2001Co-Authors: David G Mcleod, Kevin M Tomera, Norman Zinner, Marilyn Campion, Donald F Gleason, Nick Fotheringham, Marc B GarnickAbstract:Objectives. To evaluate the levels of testosterone and other hormones in men with prostate cancer treated with Abarelix versus leuprolide acetate. Methods. Patients (n = 269) were randomized to receive open-label Abarelix 100 mg or leuprolide acetate 7.5 mg by intramuscular injection. The results of the first 84 days of the study are reported. The primary efficacy endpoints included avoidance of testosterone surge, castration on day 8, and achievement and maintenance of castration from days 29 through 85. The secondary endpoints included castration on days 2, 4, and 15; a reduction in prostate-specific antigen level; and measurements of other hormones. Patients were monitored for clinical adverse events and laboratory abnormalities. Results. No men in the Abarelix group and 82% of men in the leuprolide acetate group experienced a testosterone surge (P <0.001). Abarelix caused rapid medical castration: 24% of men 1 day after treatment and 78% after 7 days compared with 0% of men treated with leuprolide acetate on either day. A comparable percentage of men achieved and maintained castration between days 29 and 85 in each group. Prostate-specific antigen had a statistically significant decrease for the first month in patients treated with Abarelix. Dihydrotestosterone, luteinizing hormone, prostate-specific antigen, and follicle-stimulating hormone showed similar rapid reductions without an initial increase. The overall occurrence of adverse events was similar across the treatment groups, and most were sequelae of comorbid disorders. Conclusions. Treatment with Abarelix produced a higher percentage of patients who avoided a testosterone surge and had a more rapid time to testosterone suppression with a higher rate of medical castration 1 day after treatment and greater reductions in testosterone, luteinizing hormone, follicle-stimulating hormone, and dihydrotestosterone during the first 2 weeks of treatment compared with leuprolide acetate. The achievement and maintenance of castration was comparable between the two groups.
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the gonadotropin releasing hormone antagonist Abarelix depot versus luteinizing hormone releasing hormone agonists leuprolide or goserelin initial results of endocrinological and biochemical efficacies in patients with prostate cancer
The Journal of Urology, 2001Co-Authors: Kevin M Tomera, Donald M Gleason, Marc Gittelman, William Moseley, Norman Zinner, Myron Murdoch, Mani Menon, Marilyn Campion, Marc B GarnickAbstract:Purpose: We contrasted the endocrinological and biochemical efficacies of Abarelix depot, a pure gonadotropin-releasing hormone antagonist, with a prospective concurrent control cohort receiving luteinizing hormone releasing hormone (LH-RH) agonists with or without antiandrogen for treatment of patients with prostate cancer receiving initial hormonal therapy.Materials and Methods: In this phase 2 open label study 242 patients with prostate cancer requiring initial hormonal treatment received Abarelix depot (209) or LH-RH agonists (33) with or without antiandrogen. A total of 100 mg. Abarelix depot was delivered intramuscularly every 28 days with an additional injection on day 15. LH-RH agonists with or without antiandrogen were administered according to the depot formulation used. Endocrine efficacy was measured by the absence of testosterone surge and rapidity of castration onset. The rate of prostate specific antigen decrease was assessed.Results: No patient treated with Abarelix depot had testosterone ...
Norman Zinner - One of the best experts on this subject based on the ideXlab platform.
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a phase 3 multicenter open label randomized study of Abarelix versus leuprolide acetate in men with prostate cancer
Urology, 2001Co-Authors: David G Mcleod, Kevin M Tomera, Norman Zinner, Marilyn Campion, Donald F Gleason, Nick Fotheringham, Marc B GarnickAbstract:Objectives. To evaluate the levels of testosterone and other hormones in men with prostate cancer treated with Abarelix versus leuprolide acetate. Methods. Patients (n = 269) were randomized to receive open-label Abarelix 100 mg or leuprolide acetate 7.5 mg by intramuscular injection. The results of the first 84 days of the study are reported. The primary efficacy endpoints included avoidance of testosterone surge, castration on day 8, and achievement and maintenance of castration from days 29 through 85. The secondary endpoints included castration on days 2, 4, and 15; a reduction in prostate-specific antigen level; and measurements of other hormones. Patients were monitored for clinical adverse events and laboratory abnormalities. Results. No men in the Abarelix group and 82% of men in the leuprolide acetate group experienced a testosterone surge (P <0.001). Abarelix caused rapid medical castration: 24% of men 1 day after treatment and 78% after 7 days compared with 0% of men treated with leuprolide acetate on either day. A comparable percentage of men achieved and maintained castration between days 29 and 85 in each group. Prostate-specific antigen had a statistically significant decrease for the first month in patients treated with Abarelix. Dihydrotestosterone, luteinizing hormone, prostate-specific antigen, and follicle-stimulating hormone showed similar rapid reductions without an initial increase. The overall occurrence of adverse events was similar across the treatment groups, and most were sequelae of comorbid disorders. Conclusions. Treatment with Abarelix produced a higher percentage of patients who avoided a testosterone surge and had a more rapid time to testosterone suppression with a higher rate of medical castration 1 day after treatment and greater reductions in testosterone, luteinizing hormone, follicle-stimulating hormone, and dihydrotestosterone during the first 2 weeks of treatment compared with leuprolide acetate. The achievement and maintenance of castration was comparable between the two groups.
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the gonadotropin releasing hormone antagonist Abarelix depot versus luteinizing hormone releasing hormone agonists leuprolide or goserelin initial results of endocrinological and biochemical efficacies in patients with prostate cancer
The Journal of Urology, 2001Co-Authors: Kevin M Tomera, Donald M Gleason, Marc Gittelman, William Moseley, Norman Zinner, Myron Murdoch, Mani Menon, Marilyn Campion, Marc B GarnickAbstract:Purpose: We contrasted the endocrinological and biochemical efficacies of Abarelix depot, a pure gonadotropin-releasing hormone antagonist, with a prospective concurrent control cohort receiving luteinizing hormone releasing hormone (LH-RH) agonists with or without antiandrogen for treatment of patients with prostate cancer receiving initial hormonal therapy.Materials and Methods: In this phase 2 open label study 242 patients with prostate cancer requiring initial hormonal treatment received Abarelix depot (209) or LH-RH agonists (33) with or without antiandrogen. A total of 100 mg. Abarelix depot was delivered intramuscularly every 28 days with an additional injection on day 15. LH-RH agonists with or without antiandrogen were administered according to the depot formulation used. Endocrine efficacy was measured by the absence of testosterone surge and rapidity of castration onset. The rate of prostate specific antigen decrease was assessed.Results: No patient treated with Abarelix depot had testosterone ...
