Clinical trials: Systemic Therapy
Pharmacokinetics, Epinephrine
Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals
To assess the drug exposure profile in systemic circulation of Primatene Mist by inhalation, versus Epinephrine by intramuscular injection, and ProAir HFA by inhalation in healthy adults.
- Conditions
- Pharmacokinetics, Epinephrine, Albuterol, Asthma
- Trial name
- NCT04207840
- Testing
- Epinephrine (0.125 mg/inhalation), Epinephrine Injection Auto-Injector (0.3mg/0.3mL), Albuterol Sulfate (0.09 mg/inhalation)
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Amphastar Pharmaceuticals, Inc.
Sepsis
Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.
This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU.
- Trial name
- NCT00318552
- Testing
- Meropenem
- Where
- 12 sites in Hungary
- Volunteers
- 160 people
- Sponsor
- Pfizer
Gastric Cancer, GastroEsophageal Cancer
A Clinical Study To Evaluate Camrelizumab (SHR-1210) Plus Capecitabine and Oxaliplatin Followed by Sequential Treatment With Camrelizumab Plus Apatinib Mesylate in Advanced or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJ) Without Prior Systemic Therapy
This is a randomized, open-label, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus capecitabine and oxaliplatin sequenced by SHR-1210 plus apatinib versus capecitabine and oxaliplatin as…
- Trial name
- NCT03813784
- Testing
- SHR-1210, Capecitabine, Oxaliplatin
- Where
- China
- Volunteers
- 885 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Acute Kidney Injury
A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI
The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.
- Trial name
- STOP-AKI (NCT02182440)
- Testing
- recAP
- Where
- 58 sites in United States, Austria and 9 more
- Volunteers
- 301 people
- Sponsor
- AM-Pharma
Diffuse Cutaneous Systemic Sclerosis
Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)
This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period.
- Trial name
- NCT04138485
- Testing
- IgPro10
- Where
- 77 sites in United States, Argentina and 11 more
- Sponsor
- CSL Behring
Lung Cancer, Non-small Cell Lung Cancer
Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)
1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or…
- Trial name
- HER3-Lung (NCT02134015)
- Testing
- Patritumab, Erlotinib
- Where
- 98 sites in United States, Belgium and 8 more
- Volunteers
- 145 people
- Sponsor
- Daiichi Sankyo
Scleroderma, Diffuse, Diffuse Cutaneous Systemic Sclerosis
Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis
Systemic sclerosis (SSc), or scleroderma is a connective tissue disease of autoimmune origin. It is a life-threatening orphan disease with severe physical and psychosocial consequences.
- Trial name
- FASST (NCT02503644)
- Testing
- IVA337
- Where
- 49 sites in Bulgaria, France and 8 more
- Volunteers
- 145 people
- Sponsor
- Inventiva Pharma
Melanoma
A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy
The purpose of this study is to examine real-world data among participants with stage IIIa melanoma initiating nivolumab as adjuvant treatment in the community practice setting by utilizing patient data from the United States…
- Trial name
- NCT05432622
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Bristol-Myers Squibb
Pancreatic Ductal Adenocarcinoma (mPDAC), Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
A Study Comparing Whole-Body Heat Treatment Plus Systemic Therapy to Systemic Therapy Alone, for Advanced Pancreatic Cancer
Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis and limited treatment options following failure of first-line therapy.
- Trial name
- MATTERS-2 (NCT07711067)
- Testing
- Whole-body hyperthermia, Standard-of-Care Systemic therapy
- Where
- 4 sites in Belgium, Spain
- Volunteers
- 95 people
- Sponsor
- ElmediX
Bacterial Infections
Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.
- Trial name
- NCT02527681
- Testing
- Ceftobiprole medocaril
- Where
- 14 sites in United States, Belgium and 4 more
- Volunteers
- 15 people
- Sponsor
- Basilea Pharmaceutica
Menopause, Postmenopausal Vaginal Atrophy
Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The aim of this trial is to compare the absorption of estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two different production sites, in postmenopausal women…
- Trial name
- NCT01085877
- Testing
- estradiol, 25 mcg
- Where
- Germany
- Volunteers
- 70 people
- Sponsor
- Novo Nordisk A/S
Chronic Graft-versus-host-disease
Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy
This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of KD025 in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least 2 prior lines of systemic therapy
- Trial name
- NCT03640481
- Testing
- Belumosudil (KD025)
- Where
- 35 sites in United States
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Kadmon, a Sanofi Company
Non Small Cell Lung Cancer
Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients
This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients with advanced NCLC not previously treated with systemic therapy.
- Trial name
- NCT00457119
- Testing
- RAD001
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 69 people
- Sponsor
- Novartis Pharmaceuticals
HR+/HER2- Breast Cancer
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole…
- Trial name
- KANDELA-302 (NCT07492641)
- Testing
- BGB-43395, Letrozole, Abemaciclib
- Where
- 241 sites in United States, Australia and 14 more
- Volunteers
- 1,056 people
- Sponsor
- BeOne Medicines
Systemic Lupus Erythematosus
Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76
This pooled analysis will assess data from the Phase 3 belimumab registration studies BLISS-52 (aka BEL110752) and BLISS-76 (aka BEL110751). The analysis was pre-planned and agreed prior to the unblinding of either study.
- Trial name
- NCT01914770
- Testing
- Belimumab 1 mg/kg, Belimumab 10 mg/kg
- Volunteers
- 1,016 people
- Sponsor
- GlaxoSmithKline
Sepsis, Septic Shock
Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Sepsis
One of the major health problems in the world is sepsis, the number of cases of which, according to WHO, annually reaches 20-30 million.
- Trial name
- LASSONEO (NCT05707494)
- Testing
- Efferon LPS NEO
- Where
- 7 sites in Russia
- Volunteers
- 78 people
- Sponsor
- Efferon JSC
Covid19, Cytokine Release Syndrome
Safety and Efficacy of Dapansutrile for Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome
The purpose of this study is to assess the safety and efficacy of orally administered NLRP3 inhibitor, dapansutrile, for the treatment of moderate COVID-19 symptoms and early cytokine release syndrome (CRS) in patients with…
- Trial name
- NCT04540120
- Testing
- dapansutrile capsules
- Where
- 10 sites in United States, Switzerland
- Volunteers
- 49 people
- Sponsor
- Olatec Therapeutics, Inc.
Wegeners Granulomatosis
Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's Granulomatosis
The aim of the study is to assess the efficacy (superiority testing) of gusperimus compared to conventional treatment in patients with a relapse of Wegener Granulomatosis with or without ongoing steroids, and/or immunosuppressive…
- Trial name
- SPARROW (NCT01446211)
- Testing
- Gusperimus + glucocorticoids, cyclophosphamide followed by methotrexate (azathioprine) + glucocorticoids or methotrexate (azathioprine) + glucocorticoids
- Where
- Czechia
- Volunteers
- 4 people
- Sponsor
- Nordic Pharma SAS
Septic Shock, Sepsis
VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients
This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or relative hypovolemia.
- Conditions
- Septic Shock, Sepsis, Hypovolemia
- Trial name
- NCT04257136
- Testing
- VBI-S
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Vivacelle Bio
Candidemia, Invasive Candidiases
An Open-label Study of APX001 for Treatment of Patients With Candidemia/Invasive Candidiasis Caused by Candida Auris
This is a multicenter, open-label, single arm study to evaluate the efficacy and safety of APX001 for the treatment of candidemia and/or invasive candidiasis caused by C.
- Conditions
- Candidemia, Invasive Candidiases, Candida Infection
- Trial name
- APEX (NCT04148287)
- Testing
- APX001
- Where
- 2 sites in South Africa
- Volunteers
- 9 people
- Sponsor
- Basilea Pharmaceutica