Clinical trials: sponsored by Jazz Pharmaceuticals
Breast Cancer, Gastric Cancer
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry…
- Conditions
- Breast Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Cancer
- Trial name
- NCT06695845
- Testing
- Zanidatamab
- Where
- 28 sites in United States, South Korea and 1 more
- Volunteers
- 200 people
- Sponsor
- Jazz Pharmaceuticals
HER2-expressing Cancers
A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer
This study is being done to find out if zanidatamab when given with evorpacept (ALX148) is safe and can treat patients with advanced (locally advanced [inoperable] and/or metastatic) human epidermal growth factor receptor 2…
- Trial name
- NCT05027139
- Testing
- Zanidatamab, Evorpacept
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- Jazz Pharmaceuticals
Seizures
Long-Term Follow-Up of a Cohort of Participants Prescribed Epidyolex in France in a Real-life Setting
This is a multi-center, non-interventional and prospective study of patients receiving Epidyolex as part of standard clinical practice in France.
- Trial name
- OPERA (NCT05772429)
- Testing
- Epidiolex
- Where
- 29 sites in France
- Volunteers
- 158 people
- Sponsor
- Jazz Pharmaceuticals
Lennox Gastaut Syndrome, Dravet Syndrome
Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY
This is a prospective, observational study on approximately 70-100 Real World participants affected by LGS, DS, or TSC treated with Epidyolex® as prescribed in the summary of product characteristics.
- Conditions
- Lennox Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex
- Trial name
- EpiTALY (NCT05485831)
- Testing
- Epidiolex 100 mg/mL Oral Solution
- Where
- 18 sites in Italy
- Volunteers
- 111 people
- Sponsor
- Jazz Pharmaceuticals
Tuberous Sclerosis Complex Associated Neuropsychiatric Disease
A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex
The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.
- Trial name
- EpiCom (NCT05864846)
- Testing
- Cannabidiol Oral Solution [Epidiolex]
- Where
- 19 sites in United States, Canada and 2 more
- Volunteers
- 79 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to Xywav, a low-sodium oxybate.
- Trial name
- XYLO (NCT05869773)
- Testing
- JZP258
- Where
- 43 sites in United States, Belgium and 3 more
- Volunteers
- 155 people
- Sponsor
- Jazz Pharmaceuticals
H3 K27M, Glioma
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with dordaviprone (ONC201) following…
- Trial name
- ACTION (NCT05580562)
- Testing
- Dordaviprone (ONC201)
- Where
- 162 sites in United States, Argentina and 16 more
- Volunteers
- 510 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1
Narcolepsy is a sleep disorder in which patients are not able to maintain wakefulness or require treatment to maintain wakefulness during the daytime.
- Trial name
- NCT06961266
- Testing
- JZP441
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Jazz Pharmaceuticals
Extensive-stage Small-cell Lung Cancer
To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC)
To assess the effectiveness and safety of Zepzelca in adult participants with extensive stage small cell lung cancer (SCLC) in real-world clinical practice.
- Trial name
- SCLC (NCT04894591)
- Testing
- Zepzelca
- Where
- 41 sites in United States, Canada
- Volunteers
- 272 people
- Sponsor
- Jazz Pharmaceuticals
Metastatic HER2-positive Breast Cancer
A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer
The efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants…
- Trial name
- NCT06435429
- Testing
- Zanidatamab, Trastuzumab, Eribulin
- Where
- 166 sites in United States, Australia and 13 more
- Volunteers
- 550 people
- Sponsor
- Jazz Pharmaceuticals
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
This study is conducted in two phases. The phase 1 portion of the study evaluates the safety, tolerability, pharmacokinetics (PK), recommended phase 2 dose (RP2D), and effectiveness of lurbinectedin monotherapy in pediatric…
- Conditions
- Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Ewing Sarcoma
- Trial name
- NCT05734066
- Testing
- Lurbinectedin
- Where
- 15 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Jazz Pharmaceuticals
Parkinson Disease, Tremor
A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease
This is a 17-week double-blind, placebo-controlled, randomized, flexible-dosing, parallel-group, multicenter study designed to evaluate the efficacy and safety of suvecaltamide for the treatment of moderate to severe residual…
- Trial name
- NCT05642442
- Testing
- Suvecaltamide
- Where
- 37 sites in United States, Germany and 2 more
- Volunteers
- 169 people
- Sponsor
- Jazz Pharmaceuticals
Advanced Solid Tumor, Metastatic Solid Tumor
JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
This Phase 1 first-in-human study will investigate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of JZP898 monotherapy as well as JZP898 in combination with pembrolizumab in…
- Trial name
- NCT06108050
- Testing
- JZP898, Pembrolizumab
- Where
- 10 sites in United States
- Volunteers
- 177 people
- Sponsor
- Jazz Pharmaceuticals
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With Myelodysplasia-Related Changes
VYxeoS Liposomal Italian Observational Study iN the Real Practice
The study is a prospective, single-arm, non-experimental, observational study in patients in Italy with Acute Myeloid Leukaemia (AML) with myelodysplastic-related changes or therapy related AML initiating treatment with JZP351…
- Conditions
- Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Therapy-Related Acute Myeloid Leukemia
- Trial name
- VYSION (NCT06143839)
- Testing
- Vyxeos liposomal
- Where
- 24 sites in Italy
- Volunteers
- 113 people
- Sponsor
- Jazz Pharmaceuticals
Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet…
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Trial name
- NCT04485104
- Testing
- GWP42003-P
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals
HER2-amplified Biliary Tract Cancers
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or…
- Trial name
- HERIZON-BTC-01 (NCT04466891)
- Testing
- ZW25 (Zanidatamab)
- Where
- 67 sites in United States, Canada and 7 more
- Volunteers
- 87 people
- Sponsor
- Jazz Pharmaceuticals
HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for…
- Trial name
- NCT03929666
- Testing
- ZW25 (Zanidatamab), Capecitabine, Cisplatin
- Where
- 23 sites in United States, Canada and 2 more
- Volunteers
- 74 people
- Sponsor
- Jazz Pharmaceuticals
Glioma, H3 K27M
Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline Gliomas
This is an intermediate-size expanded access protocol to provide ONC201 (dordaviprone) to patients with H3 K27M-mutant and/or midline gliomas who cannot access ONC201 (dordaviprone) through clinical trials.
- Trial name
- NCT04617002
- Testing
- ONC201 (dordaviprone)
- Where
- 23 sites in United States
- Sponsor
- Jazz Pharmaceuticals
Glioma
ONC201 in Adults With Recurrent H3 K27M-mutant Glioma
This was a Phase 2, open-label, 2-arm study of dordaviprone (ONC201) in patients with recurrent H3 K27M- mutant glioma. The primary assessment of dordaviprone (ONC201) involved evaluating its anti-tumor activity through the…
- Trial name
- NCT03295396
- Testing
- Dordaviprone (ONC201)
- Where
- 9 sites in United States
- Volunteers
- 73 people
- Sponsor
- Jazz Pharmaceuticals
Essential Tremor
A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET)
This is a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of JZP385 in the treatment of adult participants with moderate to severe ET.
- Trial name
- NCT05122650
- Testing
- JZP385
- Where
- 73 sites in United States, Germany and 2 more
- Volunteers
- 420 people
- Sponsor
- Jazz Pharmaceuticals