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29 News |  |
- || alobresib (GS-5829) / Gilead
P1 data, Journal, Monotherapy: Phase 1b Study of the BET Inhibitor GS-5829 as Monotherapy and Combined with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer. (Pubmed Central) - Sep 20, 2022
GS-5829 was generally tolerated but demonstrated limited efficacy and lack of dose-proportional increases in plasma concentrations in patients with mCRPC.
- |||||| enzalutamide capsule / Generic mfg., alobresib (GS-5829) / Gilead
Clinical, Combination therapy: Phase 1b study in patients with metastatic #CRPC showed that BET inhibitor GS-5829 alone or in combination with #enzalutamide was generally well tolerated but had limited clinical efficacy. https://t.co/nr6kmiDkGM @AarmstrongDuke (Twitter) - Jul 29, 2022
- Next Questions: Chronic Lymphocytic Leukemia (Level 4, Grand Ballroom G-L) - Jul 26, 2022 - Abstract #SOHO2022SOHO_274;
Another BET inhibitor, JQ1, increases venetoclax induced apoptosis...Longer follow up is warranted to evaluate if the current combinations are the best way to benefi t from the effi cacy of BTK and Bcl2 inhibitors, and we have to integrate more biological data to propose more personalized therapies. We should keep in mind that CLL treatment is not a sprint, but a long distance race.
- | GS-5829 / Gilead
Biomarker, Journal: Integrative Analysis of MAPK14 as a Potential Biomarker for Cardioembolic Stroke. (Pubmed Central) - May 28, 2021
In accordance with the results of the weighted gene coexpression network analysis (WGCNA) in the GSE58294 dataset, 11 CS-related coexpression network modules were identified in this study...In a nutshell, MAPK14 screened out by using WGCNA showed differential expression in CS. We conclude that MAPK14 can be used as a potential biological marker of CS and exhibits potential to predict the physiopathological condition of CS patients.
- ||| alobresib (GS-5829) / Gilead
Trial termination: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 (Alobresib) as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - Dec 8, 2020
P1b/2, N=31, Terminated, Sponsor: Gilead Sciences
We conclude that MAPK14 can be used as a potential biological marker of CS and exhibits potential to predict the physiopathological condition of CS patients. Completed --> Terminated
- | Nutlin-3 / EMD Serono, MG132 / Jilin University, Dorothy M. Davis Heart and Lung Research Institute, GS-5829 / Gilead
Journal: Ctnnb1 transcriptional upregulation compensates for Mdm2/p53-mediated β-catenin degradation in neutrophils following cardioembolic stroke. (Pubmed Central) - Nov 6, 2020
Completed --> Terminated Compensatory Ctnnb1 transcriptional upregulation in neutrophils induced by ischemic neuron exposure may be involved in promoting neutrophil survival following cardioembolic stroke.
- | alobresib (GS-5829) / Gilead
Journal: The BET inhibitor GS-5829 targets chronic lymphocytic leukemia cells and their supportive microenvironment. (Pubmed Central) - Oct 10, 2020
In cocultures that mimic the lymph node microenvironment, GS-5829 inhibited signaling pathways within nurselike cells and their growth, indicating that BET inhibitors also can target the supportive CLL microenvironment. Collectively, these data provide a rationale for the clinical evaluation of BET inhibitors in CLL.
- | GS-5829 / Gilead, GS-626510 / Gilead
Journal: Inhibition of BET bromodomain proteins with GS-5829 and GS-626510 in Uterine Serous Carcinoma, a biologically aggressive variant of Endometrial Cancer. (Pubmed Central) - Dec 21, 2019
GS-5829 and GS-626510 may represent novel, highly effective therapeutics agents against recurrent/chemotherapy resistant USC overexpressing c-Myc. Clinical studies with GS-5829 in USC-patients harboring chemotherapy-resistant disease are warranted.
- | alobresib (GS-5829) / Gilead
Trial completion: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 (Alobresib) as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - Oct 22, 2019
P1b/2, N=31, Completed, Sponsor: Gilead Sciences
Clinical studies with GS-5829 in USC-patients harboring chemotherapy-resistant disease are warranted. Active, not recruiting --> Completed
- GS-5829 / Gilead
The BET inhibitor GS-5829 targets chronic lymphocytic leukemia cells and their supportive microenvironment () - Oct 9, 2019 - Abstract #iwCLL2019IWCLL_11;
- | alobresib (GS-5829) / Gilead
Trial completion date: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 (Alobresib) as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - Mar 1, 2019
P1b/2, N=31, Active, not recruiting, Sponsor: Gilead Sciences
Active, not recruiting --> Completed Trial completion date: Dec 2018 --> Sep 2019
- | alobresib (GS-5829) / Gilead
Enrollment change, Trial termination, Combination therapy, Metastases: GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer (clinicaltrials.gov) - Sep 24, 2018
P1b/2, N=11, Terminated, Sponsor: Gilead Sciences
Trial completion date: Dec 2018 --> Sep 2019 N=150 --> 11 | Active, not recruiting --> Terminated
- || alobresib (GS-5829) / Gilead
Trial completion date, Trial primary completion date, Combination therapy, Metastases: GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer (clinicaltrials.gov) - Apr 25, 2018
P1b/2, N=150, Active, not recruiting, Sponsor: Gilead Sciences
N=150 --> 11 | Active, not recruiting --> Terminated Trial completion date: Feb 2021 --> Aug 2018 | Trial primary completion date: Mar 2019 --> Aug 2018
- | alobresib (GS-5829) / Gilead
Enrollment change, Trial completion date, Trial primary completion date: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 (Alobresib) as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - Apr 23, 2018
P1b/2, N=31, Active, not recruiting, Sponsor: Gilead Sciences
Trial completion date: Feb 2021 --> Aug 2018 | Trial primary completion date: Mar 2019 --> Aug 2018 N=132 --> 31 | Trial completion date: Oct 2019 --> Dec 2018 | Trial primary completion date: May 2019 --> Oct 2017
- ||| alobresib (GS-5829) / Gilead
Enrollment closed, Combination therapy, Metastases: GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer (clinicaltrials.gov) - Feb 22, 2018
P1b/2, N=150, Active, not recruiting, Sponsor: Gilead Sciences
N=132 --> 31 | Trial completion date: Oct 2019 --> Dec 2018 | Trial primary completion date: May 2019 --> Oct 2017 Recruiting --> Active, not recruiting
- ||| alobresib (GS-5829) / Gilead
Enrollment closed: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 (Alobresib) as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - Jan 29, 2018
P1b/2, N=132, Active, not recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- | alobresib (GS-5829) / Gilead
Trial completion, Trial primary completion date, Combination therapy, Monotherapy, Metastases: Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov) - Oct 20, 2017
P1, N=33, Completed, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial primary completion date: Dec 2018 --> Oct 2017
- alobresib (GS-5829) / Gilead
Enrollment closed, Enrollment change, Combination therapy, Monotherapy, Metastases: Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov) - Jun 9, 2017
P1, N=33, Active, not recruiting, Sponsor: Gilead Sciences
Active, not recruiting --> Completed | Trial primary completion date: Dec 2018 --> Oct 2017 Recruiting --> Active, not recruiting | N=160 --> 33
- | alobresib (GS-5829) / Gilead
Phase classification, Combination therapy, Metastases: GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer (clinicaltrials.gov) - May 24, 2017
P1b/2, N=150, Recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting | N=160 --> 33 Phase classification: P1b --> P1b/2
- || alobresib (GS-5829) / Gilead
Trial primary completion date: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 (Alobresib) as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - Apr 6, 2017
P1b/2, N=132, Recruiting, Sponsor: Gilead Sciences
Phase classification: P1b --> P1b/2 Trial primary completion date: Mar 2018 --> May 2019
- || alobresib (GS-5829) / Gilead
Trial primary completion date, Combination therapy, Monotherapy, Metastases: Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov) - Mar 27, 2017
P1, N=160, Recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Mar 2018 --> May 2019 Trial primary completion date: Mar 2017 --> Dec 2018
- ||| alobresib (GS-5829) / Gilead
Enrollment open, Combination therapy, Metastases: GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer (clinicaltrials.gov) - Jan 13, 2017
P1b, N=180, Recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Mar 2017 --> Dec 2018 Not yet recruiting --> Recruiting
- ||| alobresib (GS-5829) / Gilead
New P1 trial, Combination therapy, Metastases: GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer (clinicaltrials.gov) - Dec 5, 2016
P1b, N=180, Not yet recruiting, Sponsor: Gilead Sciences
- || alobresib (GS-5829) / Gilead
Phase classification, Trial primary completion date: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 (Alobresib) as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - Aug 16, 2016
P1b/2, N=132, Recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Phase classification: P1/2 --> P1b/2 | Trial primary completion date: Oct 2018 --> Mar 2018
- || alobresib (GS-5829) / Gilead
Enrollment change, Combination therapy, Monotherapy, Metastases: Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov) - Jun 28, 2016
P1, N=160, Recruiting, Sponsor: Gilead Sciences
Phase classification: P1/2 --> P1b/2 | Trial primary completion date: Oct 2018 --> Mar 2018 N=120 --> 160
- || alobresib (GS-5829) / Gilead
Enrollment change, Trial primary completion date, Combination therapy, Monotherapy, Metastases: Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov) - May 6, 2016
P1, N=120, Recruiting, Sponsor: Gilead Sciences
N=120 --> 160 N=48 --> 120 | Trial primary completion date: Oct 2016 --> Mar 2017
- |||| alobresib (GS-5829) / Gilead
Enrollment open: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 (Alobresib) as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - Dec 22, 2015
P1/2, N=112, Recruiting, Sponsor: Gilead Sciences
N=48 --> 120 | Trial primary completion date: Oct 2016 --> Mar 2017 Not yet recruiting --> Recruiting
- ||||| alobresib (GS-5829) / Gilead
New P1/2 trial: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 (Alobresib) as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - Nov 17, 2015
P1/2, N=112, Not yet recruiting, Sponsor: Gilead Sciences
- alobresib (GS-5829) / Gilead
Trial primary completion date, Combination therapy, Monotherapy, Metastases: Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov) - Aug 21, 2015
P1, N=48, Recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Trial primary completion date: Feb 2017 --> Oct 2016
- | alobresib (GS-5829) / Gilead
New P1 trial, Combination therapy, Monotherapy, Metastases: Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alobresib (Formerly GS-5829) in Adults With Advanced Solid Tumors and Lymphomas and in Combination With Exemestane or Fulvestrant in Adults With Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov) - Mar 20, 2015
P1, N=48, Recruiting, Sponsor: Gilead Sciences