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22 Diseases |  |
2 Trials |
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- || Zolinza (vorinostat) / Merck (MSD), Farydak (panobinostat) / Novartis, pracinostat (SB939) / Helsinn, MEI, Menarini
Review, Journal: HDAC Inhibitors in Acute Myeloid Leukemia. (Pubmed Central) - Nov 22, 2019
In this review, we discuss the rationale for the use of different HDACi in patients with AML, the results of preclinical studies, and the results obtained in clinical trials. Although so far the results with HDACi in clinical trials in AML have been modest, there are some encouraging data from treatment with the HDACi Pracinostat in combination with DNA demethylating agents.
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Journal: Crebbp loss drives small cell lung cancer and increases sensitivity to HDAC inhibition. (Pubmed Central) - Nov 11, 2019
Treatment with the histone deacetylase (HDAC) inhibitor Pracinostat increased histone acetylation and restored CDH1 expression...Additionally, a subset of Rb1/Trp53/Crebbp-deficient SCLC exhibited exceptional responses to Pracinostat in vivo. Thus, CREBBP acts as a potent tumor suppressor in SCLC and inactivation of CREBBP enhances responses to a targeted therapy.
- azacitidine / Generic mfg., pracinostat (SB939) / Helsinn, MEI, Menarini
A Phase 3 Randomized Study (PRIMULA) of the Epigenetic Combination of Pracinostat, a Pan-Histone Deacetylase (HDAC) Inhibitor, with Azacitidine (AZA) in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Unfit for Standard Intensive Chemotherapy (IC) (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_3827;
P3
One interim analysis is planned when 260 events (i.e., deaths due to any cause) have occurred. Enrollment is open and as of July 8, 2019 257 patients have been randomized.
- ||| pracinostat (SB939) / Helsinn, MEI, Menarini
our #Targets19 abstract on the #HDAC inhibitor #pracinostat in #leukemia is on-line https://t.co/vxVOeQZVP0 #Targets19 @USI_en @USI_university @HelsinnGroup (Twitter) - Oct 16, 2019
- azacitidine / Generic Mfg., pracinostat (SB939) / Helsinn, MEI, Menarini
The histone deacetylase inhibitor pracinostat and its metabolite SB991 are active as single agents and in combination with 5-azacitidine in acute myeloid leukemia cells (Board 9: Level 2 - Hall D) - Sep 18, 2019 - Abstract #AACRNCIEORTC2019AACR_NCI_EORTC_232;
P3
Combination of pracinostat with 5-azacitidine enhanced its activity in AML cells. These results provide pre-clinical rationale for the ongoing phase 3 trials of pracinostat in combination with azacitidine in AML.
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Trial completion: A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body (clinicaltrials.gov) - Aug 8, 2019
P1, N=6, Completed, Sponsor: Helsinn Healthcare SA
These results provide pre-clinical rationale for the ongoing phase 3 trials of pracinostat in combination with azacitidine in AML. Enrolling by invitation --> Completed
- || pracinostat (SB939) / Helsinn, MEI, Menarini
#Helsinn and Endo Announce Agreement for #Paladin Labs Inc. to Commercialize #Pracinostat in Canada $ENDP https://t.co/HyEU5bbV2q (Twitter) - Aug 2, 2019
- | abexinostat (CG-781) / Xynomic, pracinostat (SB939) / Helsinn, MEI, Menarini, quisinostat (JNJ 26481585) / J&J, ChemRar
Journal: HDAC Inhibitors Induce BDNF Expression and Promote Neurite Outgrowth in Human Neural Progenitor Cells-Derived Neurons. (Pubmed Central) - Jun 15, 2019
Furthermore, by using well-developed immunohistochemistry assays, the selected compounds were also proved to have neurogenic potential improving the neurite outgrowth in HNPCs-derived neurons. In conclusion, we proved the neurogenic potential of several hb-HDACis, alongside their ability to enhance BDNF expression, which by modulating the neurogenesis and/or compensating for neuronal loss, could be propitious for treatment of neurological disorders.
- | pracinostat (SB939) / Helsinn, MEI, Menarini, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Enrollment open, Combination therapy: Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Jun 11, 2019
P1, N=18, Recruiting, Sponsor: Medical College of Wisconsin
In conclusion, we proved the neurogenic potential of several hb-HDACis, alongside their ability to enhance BDNF expression, which by modulating the neurogenesis and/or compensating for neuronal loss, could be propitious for treatment of neurological disorders. Not yet recruiting --> Recruiting
- |||| Jakafi oral (ruxolitinib) / Novartis, Incyte, pracinostat (SB939) / Helsinn, MEI, Menarini
Clinical: A phase 2 study of pracinostat combined with ruxolitinib in patients with myelofibrosis #MPNSM @LeukemiaMDA https://t.co/HJiKJ2oKlL (Twitter) - May 8, 2019
- || pracinostat (SB939) / Helsinn, MEI, Menarini
Enrollment closed, Trial primary completion date: A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes (clinicaltrials.gov) - Mar 14, 2019
P2, N=60, Active, not recruiting, Sponsor: Helsinn Healthcare SA
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2020 --> Mar 2020
- | pracinostat (SB939) / Helsinn, MEI, Menarini, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
New P1 trial, Combination therapy: Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Feb 21, 2019
P1, N=18, Not yet recruiting, Sponsor: Medical College of Wisconsin
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Trial completion, Trial completion date, Trial primary completion date, Combination therapy: Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome (clinicaltrials.gov) - Sep 13, 2018
P2, N=102, Completed, Sponsor: Helsinn Healthcare SA
Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2020 --> Mar 2020 Trial completion date: Dec 2017 --> Nov 2016 | Trial primary completion date: Dec 2017 --> Nov 2015 | Active, not recruiting --> Completed
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Trial completion, Trial completion date, Trial primary completion date, Combination therapy: Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Sep 13, 2018
P2, N=50, Completed, Sponsor: Helsinn Healthcare SA
Trial completion date: Dec 2017 --> Nov 2016 | Trial primary completion date: Dec 2017 --> Nov 2015 | Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial completion date: Dec 2017 --> Jun 2017 | Trial primary completion date: Dec 2017 --> Jun 2017
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Enrollment change: A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes (clinicaltrials.gov) - Aug 23, 2018
P2, N=60, Recruiting, Sponsor: Helsinn Healthcare SA
Active, not recruiting --> Completed | Trial completion date: Dec 2017 --> Jun 2017 | Trial primary completion date: Dec 2017 --> Jun 2017 N=120 --> 60
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Trial completion date, Trial primary completion date: A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body (clinicaltrials.gov) - Aug 6, 2018
P1, N=6, Enrolling by invitation, Sponsor: Helsinn Healthcare SA
N=120 --> 60 Trial completion date: Aug 2018 --> Nov 2018 | Trial primary completion date: Apr 2018 --> Oct 2018
- || Jakafi (ruxolitinib) / Incyte, pracinostat (SB939) / Helsinn, MEI, Menarini
Trial completion, Trial completion date, Trial primary completion date, Combination therapy: Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF) (clinicaltrials.gov) - Jun 28, 2018
P2, N=25, Completed, Sponsor: M.D. Anderson Cancer Center
Trial completion date: Aug 2018 --> Nov 2018 | Trial primary completion date: Apr 2018 --> Oct 2018 Active, not recruiting --> Completed | Trial completion date: Jan 2021 --> Jun 2018 | Trial primary completion date: Jan 2020 --> Jun 2018
- pracinostat (SB939) / Helsinn, MEI, Menarini
New P1 trial: A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body (clinicaltrials.gov) - Apr 11, 2018
P1, N=6, Enrolling by invitation, Sponsor: Helsinn Healthcare SA
- Jakafi (ruxolitinib) / Incyte, pracinostat (SB939) / Helsinn, MEI, Menarini
Trial completion date, Trial primary completion date, Combination therapy: Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF) (clinicaltrials.gov) - Mar 23, 2018
P2, N=25, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Active, not recruiting --> Completed | Trial completion date: Jan 2021 --> Jun 2018 | Trial primary completion date: Jan 2020 --> Jun 2018 Trial completion date: Jan 2019 --> Jan 2021 | Trial primary completion date: Jan 2019 --> Jan 2020
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Journal: Phase 1 dose escalation multicenter trial of pracinostat alone and in combination with azacitidine in patients with advanced hematologic malignancies. (Pubmed Central) - Dec 16, 2017
The results of the current study demonstrate that pracinostat is safe, with modest single-agent activity in patients with hematological malignancies. Cancer 2017;123:4851-9.
- |||||| pracinostat (SB939) / Helsinn, MEI, Menarini
Enrollment open, Combination therapy: PRIMULA : An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia (clinicaltrials.gov) - Jul 13, 2017
P3, N=500, Recruiting, Sponsor: Helsinn Healthcare SA
Cancer 2017;123:4851-9. Not yet recruiting --> Recruiting
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Journal: Phase 2, randomized, double-blind study of pracinostat in combination with azacitidine in patients with untreated, higher risk myelodysplastic syndromes. (Pubmed Central) - Jun 2, 2017
Higher rates of treatment discontinuation may partially explain these results, suggesting alternative dosing and schedules to improve tolerability may be required to determine the potential of the combination. Cancer 2017;123:994-1002.
- |||| pracinostat (SB939) / Helsinn, MEI, Menarini
Enrollment open: A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes (clinicaltrials.gov) - May 29, 2017
P2, N=120, Recruiting, Sponsor: Helsinn Healthcare SA
Cancer 2017;123:994-1002. Not yet recruiting --> Recruiting
- |||||||||| pracinostat (SB939) / Helsinn, MEI, Menarini
New P3 trial, Combination therapy: PRIMULA : An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia (clinicaltrials.gov) - May 11, 2017
P3, N=500, Not yet recruiting, Sponsor: Helsinn Healthcare SA
- ||||| pracinostat (SB939) / Helsinn, MEI, Menarini
New P2 trial: A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes (clinicaltrials.gov) - May 11, 2017
P2, N=120, Not yet recruiting, Sponsor: Helsinn Healthcare SA
- | Jakafi (ruxolitinib) / Incyte, pracinostat (SB939) / Helsinn, MEI, Menarini
Enrollment closed, Combination therapy: Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF) (clinicaltrials.gov) - Apr 28, 2017
P2, N=25, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || pracinostat (SB939) / Helsinn, MEI, Menarini
Trial primary completion date, Combination therapy: Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome (clinicaltrials.gov) - Apr 24, 2017
P2, N=102, Active, not recruiting, Sponsor: Helsinn Healthcare SA
Recruiting --> Active, not recruiting Trial primary completion date: Mar 2017 --> Dec 2017
- pracinostat (SB939) / Helsinn, MEI, Menarini
Trial primary completion date, Combination therapy: Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Feb 27, 2017
P2, N=50, Active, not recruiting, Sponsor: Helsinn Healthcare SA
Trial primary completion date: Mar 2017 --> Dec 2017 Trial primary completion date: Nov 2016 --> Dec 2017
- Jakafi (ruxolitinib) / Incyte, pracinostat (SB939) / Helsinn, MEI, Menarini
Trial primary completion date, Combination therapy: Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF) (clinicaltrials.gov) - Jan 26, 2017
P2, N=25, Recruiting, Sponsor: M.D. Anderson Cancer Center
Trial primary completion date: Nov 2016 --> Dec 2017 Trial primary completion date: Jan 2018 --> Jan 2019
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Trial completion: Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA (clinicaltrials.gov) - Jul 6, 2016
P2, N=45, Completed, Sponsor: MEI Pharma, Inc.
Trial primary completion date: Jan 2018 --> Jan 2019 Active, not recruiting --> Completed
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Enrollment closed: Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA (clinicaltrials.gov) - Apr 18, 2016
P2, N=45, Active, not recruiting, Sponsor: MEI Pharma, Inc.
Active, not recruiting --> Completed Completed --> Active, not recruiting
- ||| pracinostat (SB939) / Helsinn, MEI, Menarini
Enrollment closed, Trial primary completion date, Combination therapy: Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome (clinicaltrials.gov) - Apr 18, 2016
P2, N=102, Active, not recruiting, Sponsor: MEI Pharma, Inc.
Completed --> Active, not recruiting Completed --> Active, not recruiting | Trial primary completion date: May 2015 --> Mar 2017
- pracinostat (SB939) / Helsinn, MEI, Menarini
Trial primary completion date, Combination therapy: Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Mar 16, 2016
P2, N=50, Active, not recruiting, Sponsor: MEI Pharma, Inc.
Completed --> Active, not recruiting | Trial primary completion date: May 2015 --> Mar 2017 Trial primary completion date: Dec 2015 --> Nov 2016
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Trial completion, Enrollment change, Trial primary completion date: Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA (clinicaltrials.gov) - Mar 16, 2016
P2, N=45, Completed, Sponsor: MEI Pharma, Inc.
Trial primary completion date: Dec 2015 --> Nov 2016 Active, not recruiting --> Completed | N=76 --> 45 | Trial primary completion date: Aug 2015 --> May 2015
- |||| pracinostat (SB939) / Helsinn, MEI, Menarini
Trial completion, Combination therapy: Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome (clinicaltrials.gov) - Mar 16, 2016
P2, N=102, Completed, Sponsor: MEI Pharma, Inc.
Active, not recruiting --> Completed | N=76 --> 45 | Trial primary completion date: Aug 2015 --> May 2015 Active, not recruiting --> Completed
- || pracinostat (SB939) / Helsinn, MEI, Menarini
Trial primary completion date: Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA (clinicaltrials.gov) - Jun 18, 2015
P2, N=76, Active, not recruiting, Sponsor: MEI Pharma, Inc.
Active, not recruiting --> Completed Trial primary completion date: Mar 2015 --> Aug 2015
- pracinostat (SB939) / Helsinn, MEI, Menarini
Trial primary completion date, Combination therapy: Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Jun 18, 2015
P2, N=50, Active, not recruiting, Sponsor: MEI Pharma, Inc.
Trial primary completion date: Mar 2015 --> Aug 2015 Trial primary completion date: Feb 2015 --> Dec 2015
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Trial completion: Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects (clinicaltrials.gov) - Jun 18, 2015
P1, N=32, Completed, Sponsor: MEI Pharma, Inc.
Trial primary completion date: Feb 2015 --> Dec 2015 Active, not recruiting --> Completed
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Trial completion: Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects (clinicaltrials.gov) - Jun 18, 2015
P0, N=28, Completed, Sponsor: MEI Pharma, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- pracinostat (SB939) / Helsinn, MEI, Menarini
Trial completion, Trial primary completion date, Metastases: SB939 in Treating Patients With Recurrent or Metastatic Prostate Cancer (clinicaltrials.gov) - Feb 19, 2015
P2, N=32, Completed, Sponsor: NCIC Clinical Trials Group
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial primary completion date: Mar 2014 --> Jan 2015
- ||| pracinostat (SB939) / Helsinn, MEI, Menarini
Enrollment closed: Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA (clinicaltrials.gov) - Jan 22, 2015
P2, N=76, Active, not recruiting, Sponsor: MEI Pharma, Inc.
Active, not recruiting --> Completed | Trial primary completion date: Mar 2014 --> Jan 2015 Recruiting --> Active, not recruiting
- | Jakafi (ruxolitinib) / Incyte, pracinostat (SB939) / Helsinn, MEI, Menarini
Enrollment open, Combination therapy: Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF) (clinicaltrials.gov) - Jan 15, 2015
P2, N=25, Recruiting, Sponsor: M.D. Anderson Cancer Center
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Jakafi (ruxolitinib) / Incyte, pracinostat (SB939) / Helsinn, MEI, Menarini
Trial initiation date, Trial primary completion date, Combination therapy: Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF) (clinicaltrials.gov) - Jan 2, 2015
P2, N=25, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
Not yet recruiting --> Recruiting Initiation date: Dec 2014 --> Mar 2015 | Trial primary completion date: Dec 2017 --> Mar 2018
- | pracinostat (SB939) / Helsinn, MEI, Menarini
Enrollment closed, Combination therapy: Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Dec 9, 2014
P2, N=50, Active, not recruiting, Sponsor: MEI Pharma, Inc.
Initiation date: Dec 2014 --> Mar 2015 | Trial primary completion date: Dec 2017 --> Mar 2018 Recruiting --> Active, not recruiting
- | Jakafi (ruxolitinib) / Incyte, pracinostat (SB939) / Helsinn, MEI, Menarini
New P2 trial, Combination therapy: Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF) (clinicaltrials.gov) - Oct 17, 2014
P2, N=25, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
- pracinostat (SB939) / Helsinn, MEI, Menarini
Enrollment closed: Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects (clinicaltrials.gov) - Sep 28, 2014
P1, N=32, Active, not recruiting, Sponsor: MEI Pharma, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Active, not recruiting
- ||| pracinostat (SB939) / Helsinn, MEI, Menarini
Enrollment closed, Combination therapy: Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome (clinicaltrials.gov) - Sep 5, 2014
P2, N=100, Active, not recruiting, Sponsor: MEI Pharma, Inc.
Not yet recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- pracinostat (SB939) / Helsinn, MEI, Menarini
Enrollment closed: Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects (clinicaltrials.gov) - Apr 21, 2014
P0, N=28, Active, not recruiting, Sponsor: MEI Pharma, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- | pracinostat (SB939) / Helsinn, MEI, Menarini
New P1 trial: Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects (clinicaltrials.gov) - Apr 17, 2014
P1, N=32, Not yet recruiting, Sponsor: MEI Pharma, Inc.
- pracinostat (SB939) / Helsinn, MEI, Menarini
Trial completion: A Phase I Study of SB939 in Pediatric Patients With Refractory Solid Tumours and Leukemia (clinicaltrials.gov) - Jan 15, 2014
P1, N=12, Completed, Sponsor: NCIC Clinical Trials Group
Recruiting --> Active, not recruiting Active, not recruiting --> Completed