Fiche société
Jazz Pharmaceuticals
Traitements, essais et publications liés.
Traitements21programmes
Essais10liés
Publications21liées
SourceDBlocale
Traitements
21| Molécule | Indication / population | Phase | Objectif | Pays | Résultat |
|---|---|---|---|---|---|
| CannabidiolThe clinical trial "A Prospective Single-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet syndrome and Lennox-Gastaut Syndrome" is a single-group phase III study done in single tertiary referral center in Seoul, Korea. Chief investigator is Dr. Hoon-Chul Kang of Severance Hospital, Yonsei University College of Medicine. Associate investigators are Dr. Heung Dong Kim, Joon Soo Lee, Se Hee Kim, Han Som Choi, Ji Hoon Na, Dong Hwa Yang, and Hee Jung Kang, of Severance Hospital, Yonsei University College of Medicine. The aim of the study is to evaluate the effect of cannabidiol (CBD-OS®) on cognitive functions in patients aged from 2 to 18 years old diagnosed with Dravet syndrome or Lennox-Gastaut syndrome. The duration of study is planned as one year, after patient recruitment of 6 months. The intervention period in each patient is 24 weeks, with 2 weeks of medication titration, stabilization period of 10 weeks, and maintenance period of 12 weeks. The recruitment goal of patient number is 104, considering the study power of 90 percent. Primary outcomes are improvement of cognitive and development and improvement of seizure outcome. Secondary outcomes are improvement in behavior and quality of life. Safety monitoring criteria are adverse event profiles and physician's and caregiver's global assessment. Statistical analysis of outcomes is subject only to the patients who completed the 24-week medication and 2 times of tests before and after treatment of cannabidiol. Evaluation of seizure outcomes would include all patients who completed the 24-week medication and those who dropped out of the study, either by follow-up loss or discontinuation of medication due to incomplete seizure control or adverse effect of the medication. To evaluate safety, the investigators would measure adverse events and dropout rates by percentage. The investigators would analyze overall evaluation of the caregivers and investigator. Serious adverse events would be noted after causality evaluation. | Épilepsie | Phase 4 | À vérifier | United States | À vérifier |
| Cannabidiol Oral SolutionThis is a Phase 3b/Phase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults. | Épilepsie | Phase 4 | À vérifier | United States | À vérifier |
| CBD-OSThe efficacy, safety, and tolerability of CBD-OS have been evaluated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and Tuberous sclerosis complex (TSC). The current JZP926-303 study is being conducted to evaluate the safety and efficacy of CBD-OS in participants with Developmental and Epileptic Encephalopathy (DEE). | Épilepsie | Phase 3 | À vérifier | À vérifier | |
| JZP926 capsuleThis study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME). | Épilepsie | Phase 2/3 | À vérifier | United States | À vérifier |
| ONC201This is an intermediate-size expanded access protocol to provide ONC201 to patients with diffuse intrinsic pontine gliomas who cannot access ONC201 through clinical trials. | Cancer | À vérifier | À vérifier | United States | À vérifier |
| ONC206This is a two-stage Phase 2 trial evaluating the efficacy and safety of ONC206 in participants with Pheochromocytoma and Paraganglioma (PCPG). | Cancer | Phase 2 | À vérifier | United States | À vérifier |
| ONC206: Dose 1This is a two-stage Phase 2 trial evaluating the efficacy and safety of ONC206 in participants with Pheochromocytoma and Paraganglioma (PCPG). | Cancer | Phase 2 | À vérifier | United States | À vérifier |
| ONC206: Dose 2This is a two-stage Phase 2 trial evaluating the efficacy and safety of ONC206 in participants with Pheochromocytoma and Paraganglioma (PCPG). | Cancer | Phase 2 | À vérifier | United States | À vérifier |
| OxaliplatinImmune therapies work with the body's immune system to treat a number of cancers. They work with T-cells, a type of white blood cell, to target and attack specific tumors. However, some tumors can become resistant to attack by T-cells over time. They do this by sending "off" signals to T-cells. The researchers are finding ways to switch the T-cells back on. Before a treatment can be approved for use, clinical studies need to be done. This study will provide more information on ASP1570 in adults with advanced solid tumors. ASP1570 will either be given by itself, or given with another medicine called pembrolizumab, given with a standard cancer therapy, or given together with pembrolizumab and other medicines called pemetrexed and carboplatin. The main aims of this study are： * To check the safety of ASP1570 * To check how well ASP1570 is tolerated * To find a suitable dose of ASP1570 This study is for adults with advanced solid tumors. Their tumor has either grown outside of the area where it started (locally advanced and unresectable) or it has spread to other parts of the body (metastatic). Their cancer gets worse after standard therapy or they are unable to have standard therapy. The study doctors can give more advice about who can take part. This study will be in 2 parts. In Part 1, the most suitable dose of ASP1570 to give to people with advanced solid tumors will be worked out. Different small groups of people with advanced solid tumors will take lower to higher doses of ASP1570. People will either be given ASP1570 by itself, or ASP1570 with pembrolizumab, ASP1570 with a standard cancer therapy, or ASP1570 with pembrolizumab, pemetrexed and carboplatin. The study treatment given depends on the type of cancer people have. There are different doses of ASP1570, with each group staying on the same dose. There is just 1 standard dose of pembrolizumab. The dose of a standard cancer therapy depends on its label. After taking the lowest dose of ASP1570, the first group will be checked for medical problems. The next group can only take the higher dose of ASP1570 if the first group tolerates the lowest dose. This will continue in the same way for each group. Each group will take tablets of ASP1570 either once or twice every day in a 21-day cycle. People will continue with more treatment cycles on the same dose unless they can't tolerate the study treatment, their cancer gets worse or the study doctor decides that person should stop treatment. People who also receive treatment with pembrolizumab will be infused with pembrolizumab on the first day of every other cycle of ASP1570 (once every 6 weeks). People who are receiving a standard cancer therapy (with ASP1570) will be treated according to its label. In Part 2, different small groups of people with advanced solid tumors will take the most suitable dose of ASP1570 worked out from Part 1. The dose will not go above the highest dose that people could tolerate from Part 1. ASP1570 will be given either once a day or twice a day in a 21-day cycle. Pembrolizumab will be given once every 6 weeks. Other study treatments will be given in 14-day, 21-day or 28-day cycles. The cycle length and other study treatments given (pembrolizumab and the type of standard cancer therapy will depend on what type of tumor people have. The standard cancer therapies will be given according to their label. All groups will continue with more treatment cycles with ASP1570 (by itself with pembrolizumab, with a standard cancer therapy, or with pembrolizumab, pemetrexed and carboplatin) unless they can't tolerate the study treatment, their cancer gets worse or the study doctor decides that person should stop treatment. | Cancer, Parkinson | Phase 3 | Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Estonia, … | À vérifier | |
| TrastuzumabThe purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2 peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of the study are the following: * Assess safety and document local and systemic toxicity to combination immunotherapy with GP2 peptide + GM-CSF vaccine and trastuzumab * Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab * Determine maximum tolerated dose and optimal biologic dose for the combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab | Cancer, Parkinson | Phase 3 | À vérifier | Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Estonia, … | À vérifier |
| ZanidatamabThe purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer. | Cancer, Parkinson | Phase 3 | À vérifier | Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Estonia, … | À vérifier |
| ONC201This is an intermediate-size expanded access protocol to provide ONC201 to patients with diffuse intrinsic pontine gliomas who cannot access ONC201 through clinical trials. | Cancer | À vérifier | À vérifier | United States | À vérifier |
| CannabidiolThe clinical trial "A Prospective Single-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet syndrome and Lennox-Gastaut Syndrome" is a single-group phase III study done in single tertiary referral center in Seoul, Korea. Chief investigator is Dr. Hoon-Chul Kang of Severance Hospital, Yonsei University College of Medicine. Associate investigators are Dr. Heung Dong Kim, Joon Soo Lee, Se Hee Kim, Han Som Choi, Ji Hoon Na, Dong Hwa Yang, and Hee Jung Kang, of Severance Hospital, Yonsei University College of Medicine. The aim of the study is to evaluate the effect of cannabidiol (CBD-OS®) on cognitive functions in patients aged from 2 to 18 years old diagnosed with Dravet syndrome or Lennox-Gastaut syndrome. The duration of study is planned as one year, after patient recruitment of 6 months. The intervention period in each patient is 24 weeks, with 2 weeks of medication titration, stabilization period of 10 weeks, and maintenance period of 12 weeks. The recruitment goal of patient number is 104, considering the study power of 90 percent. Primary outcomes are improvement of cognitive and development and improvement of seizure outcome. Secondary outcomes are improvement in behavior and quality of life. Safety monitoring criteria are adverse event profiles and physician's and caregiver's global assessment. Statistical analysis of outcomes is subject only to the patients who completed the 24-week medication and 2 times of tests before and after treatment of cannabidiol. Evaluation of seizure outcomes would include all patients who completed the 24-week medication and those who dropped out of the study, either by follow-up loss or discontinuation of medication due to incomplete seizure control or adverse effect of the medication. To evaluate safety, the investigators would measure adverse events and dropout rates by percentage. The investigators would analyze overall evaluation of the caregivers and investigator. Serious adverse events would be noted after causality evaluation. | Épilepsie | Phase 3 | À vérifier | South Korea | À vérifier |
| CannabidiolThe clinical trial "A Prospective Single-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet syndrome and Lennox-Gastaut Syndrome" is a single-group phase III study done in single tertiary referral center in Seoul, Korea. Chief investigator is Dr. Hoon-Chul Kang of Severance Hospital, Yonsei University College of Medicine. Associate investigators are Dr. Heung Dong Kim, Joon Soo Lee, Se Hee Kim, Han Som Choi, Ji Hoon Na, Dong Hwa Yang, and Hee Jung Kang, of Severance Hospital, Yonsei University College of Medicine. The aim of the study is to evaluate the effect of cannabidiol (CBD-OS®) on cognitive functions in patients aged from 2 to 18 years old diagnosed with Dravet syndrome or Lennox-Gastaut syndrome. The duration of study is planned as one year, after patient recruitment of 6 months. The intervention period in each patient is 24 weeks, with 2 weeks of medication titration, stabilization period of 10 weeks, and maintenance period of 12 weeks. The recruitment goal of patient number is 104, considering the study power of 90 percent. Primary outcomes are improvement of cognitive and development and improvement of seizure outcome. Secondary outcomes are improvement in behavior and quality of life. Safety monitoring criteria are adverse event profiles and physician's and caregiver's global assessment. Statistical analysis of outcomes is subject only to the patients who completed the 24-week medication and 2 times of tests before and after treatment of cannabidiol. Evaluation of seizure outcomes would include all patients who completed the 24-week medication and those who dropped out of the study, either by follow-up loss or discontinuation of medication due to incomplete seizure control or adverse effect of the medication. To evaluate safety, the investigators would measure adverse events and dropout rates by percentage. The investigators would analyze overall evaluation of the caregivers and investigator. Serious adverse events would be noted after causality evaluation. | Épilepsie | Phase 4 | À vérifier | United States | À vérifier |
| Cannabidiol Oral SolutionThis is a Phase 3b/Phase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults. | Épilepsie | Phase 4 | À vérifier | United States | À vérifier |
| CBD-OSThe efficacy, safety, and tolerability of CBD-OS have been evaluated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and Tuberous sclerosis complex (TSC). The current JZP926-303 study is being conducted to evaluate the safety and efficacy of CBD-OS in participants with Developmental and Epileptic Encephalopathy (DEE). | Épilepsie | Phase 3 | À vérifier | À vérifier | |
| JZP926 capsuleThis study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME). | Épilepsie | Phase 2/3 | À vérifier | United States | À vérifier |
| ZanidatamabThe purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer. | Cancer | Phase 3 | À vérifier | United States, Argentina, Belgium, Brazil, Canada, Chile, China, Czechia, Finland, France, Germany, India, Israel, Italy, Japan, Portugal, Puerto Rico, Romania, Serbia, South Korea, … | À vérifier |
| ZanidatamabThe purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer. | Parkinson | Phase 3 | À vérifier | Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Estonia, France, Georgia, Germany, Greece, Guatemala, India, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, … | À vérifier |
| ONC206This is a two-stage Phase 2 trial evaluating the efficacy and safety of ONC206 in participants with Pheochromocytoma and Paraganglioma (PCPG). | Cancer | Phase 2 | À vérifier | United States | À vérifier |
| Cannabidiol Oral SolutionThis is a Phase 3b/Phase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults. | Épilepsie | Phase 2 | À vérifier | Italy | À vérifier |
Essais cliniques
10| Molécule | Indication / population | Phase | NCT | Titre | Statut |
|---|---|---|---|---|---|
| Cannabidiol Oral Solution | Épilepsie | Phase 2 | NCT05803434 | CBD_RE — Cannabidiol in Children and Young Adults With Rare Disease-associated Severe Epilepsy | ACTIVE_NOT_RECRUITING |
| ONC206 | Cancer | Phase 2 | NCT07282587 | Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma | RECRUITING |
| Zanidatamab | Parkinson | Phase 3 | NCT05152147 | HERIZON-GEA-01 — A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers | ACTIVE_NOT_RECRUITING |
| Zanidatamab | Cancer | Phase 3 | NCT06282575 | Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer | RECRUITING |
| JZP926 capsule | Épilepsie | Phase 2/3 | NCT07723963 | A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy | NOT_YET_RECRUITING |
| CBD-OS | Épilepsie | Phase 3 | NCT07723976 | A Study to Evaluate the Safety and Efficacy of CBD-OS in Participants With DEE | NOT_YET_RECRUITING |
| Cannabidiol Oral Solution | Épilepsie | Phase 4 | NCT07728097 | EpiGOAL — A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS | NOT_YET_RECRUITING |
| Cannabidiol | Épilepsie | Phase 4 | NCT05044819 | Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution | ACTIVE_NOT_RECRUITING |
| Cannabidiol | Épilepsie | Phase 3 | NCT04611438 | Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome | UNKNOWN |
| ONC201 | Cancer | À vérifier | NCT05392374 | Expanded Access Use of ONC201 in a Patient With Diffuse Intrinsic Pontine Gliomas | NO_LONGER_AVAILABLE |
Publications
21| Molécule | Indication / population | Titre | Journal | Date |
|---|---|---|---|---|
| JZP926 capsule | Open-Source Artificial Intelligence in Small-Bowel Capsule Endoscopy-Visual Assistance is Promising, But Not Yet a Standard of Care. | DEN open | ||
| JZP926 capsule | Non-visualized Ultrasonography Should Remain Indeterminate in Patency Capsule Localization. | DEN open | ||
| JZP926 capsule | Risk Stratification for Rebleeding in Obscure Gastrointestinal Bleeding After Comprehensive Gastrointestinal Evaluation. | DEN open | ||
| CBD-OS | Differential Pulse Voltammetric Analysis of Cannabidiol on Fluorine-Doped Tin Oxide (FTO) Electrode Interface: Quantification in Pharmaceutical Oil with Assessment of Electrode Surface Stability. | Sensors (Basel, Switzerland) | ||
| Cannabidiol Oral Solution | Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome. | The New England journal of medicine | ||
| Cannabidiol Oral Solution | Effect of Cannabidiol on Drop Seizures in the Lennox-Gastaut Syndrome. | The New England journal of medicine | ||
| Cannabidiol | Investigation into the oral toxicity profile of TruCBN™. | Toxicology reports | ||
| Cannabidiol | Biosensing technologies for cannabinoid monitoring in pain management: Current methods, clinical needs, and translational challenges. | Journal of pharmaceutical and biomedical analysis | ||
| Trastuzumab | Cost-effectiveness of pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma. | Human vaccines & immunotherapeutics | ||
| Trastuzumab | A novel insulin-like growth factor II-based masking domain for conditional activation of therapeutic antibodies. | mAbs | ||
| Trastuzumab | Self-interaction nanoparticle spectroscopy predicts high-concentration viscosity of therapeutic IgG1 antibodies. | mAbs | ||
| ONC201 | Point/Counterpoint: Dordaviprone for diffuse midline glioma - A landmark approval or a premature step? | Neuro-oncology | ||
| ONC201 | Molecular Tumor Board: H3K27M Diffuse Midline Glioma Diagnosed During Pregnancy by Cerebrospinal Fluid Next-Generation Sequencing. | The oncologist | ||
| ONC201 | Interplay of Epigenetic Reprogramming, Mitochondrial Metabolism, and Dopamine Signalling Pathways Uncovers Metabolic Vulnerabilities in Diffuse Midline Glioma. | Cancers | ||
| Cannabidiol | Artificial Intelligence-enhanced Cannabidiol (CBD) Drug Delivery Systems: Integrating Machine Learning and Nanotechnology for Precision Therapeutic Optimization. | Mini reviews in medicinal chemistry | ||
| Cannabidiol | Synergistic effects of hydropriming and differential gamma radiation on the physiomorphic attributes of L. | International journal of radiation biology | ||
| ONC201 | Early increase in apparent diffusion coefficient predicts favorable response to Dordaviprone (ONC201) therapy in H3K27M-mutant diffuse midline glioma. | Neuro-oncology | ||
| ONC201 | Targeting mitochondrial protease in diffuse gliomas. | Molecular cancer therapeutics | ||
| ONC201 | Dysregulation of Human ClpP Using Small Molecules with Piperazine-Based Scaffold for Diffuse Intrinsic Pontine Glioma Therapy Validated by Patient-Derived Tumor Organoids. | Journal of medicinal chemistry | ||
| ONC201 | H3K27M-mutant diffuse midline glioma pharmacotherapy: Clinical evidence and practice implications of dordaviprone. | Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners | ||
| ONC201 | Small molecule activators of the mitochondrial protease ClpP induce senescence in triple-negative breast cancer cells and sensitize cells to the Bcl-2 inhibitor venetoclax. | Cell death & disease |