Clinical trials: Drug Safety
Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration
A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors
This is a first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03…
- Trial name
- NCT06716138
- Testing
- ANS03
- Where
- 5 sites in United States, China
- Volunteers
- 96 people
- Sponsor
- Avistone Biotechnology Co., Ltd.
Coronary Artery Disease, Arterial Occlusive Diseases
The ENDEAVOR II Clinical Trial: The Medtronic Endeavor Drug Eluting Coronary Stent System in Coronary Artery Lesions
To demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in native coronary arteries 2.25-3.5 mm in…
- Conditions
- Coronary Artery Disease, Arterial Occlusive Diseases, Coronary Disease, Coronary Arteriosclerosis
- Trial name
- ENDEAVOR II (NCT00614848)
- Testing
- Endeavor drug eluting coronary stent
- Where
- France
- Volunteers
- 1,200 people
- Sponsor
- Medtronic Vascular
Psoriasis, Parapsoriasis
A Study of the Safety and Effectiveness of Infliximab in Patients With Plaque-type Psoriasis
The purpose of the study is to evaluate the safety and effectiveness of scheduled and as needed treatment of psoriasis with infliximab.
- Trial name
- NCT00106847
- Testing
- Infliximab
- Volunteers
- 683 people
- Sponsor
- Centocor, Inc.
Healthy
Study to Determine the Bioavailability, Pharmacodynamic Effects, and Safety of Whole and Crushed ALO-01 Compared to Morphine Sulfate Immediate Release (MSIR)
The purpose of the study is to determine the relative pharmacodynamic effects and safety of crushed and whole ALO-01 compared to MSIR and to Placebo, and of crushed ALO-01 to whole ALO-01; to determine the relative…
- Trial name
- NCT00751478
- Testing
- ALO-01, MSIR
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer
Graft vs Host Disease, Congenital Aniridia
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely.
- Conditions
- Graft vs Host Disease, Congenital Aniridia, Chemical Burns, Stevens-Johnson Syndrome
- Trial name
- NCT02945176
- Testing
- ARGOS-IO system
- Where
- 2 sites in Germany
- Volunteers
- 13 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Neoplasm Malignant
A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET Amplification
Primary Objective: To determine objective response rate (ORR). Secondary Objectives: To assess duration of response (DR), progression free survival (PFS) and overall survival (OS). To evaluate global safety profile.
- Trial name
- NCT02435121
- Testing
- SAR125844
- Where
- Belgium
- Volunteers
- 1 people
- Sponsor
- Sanofi
Endometrial Neoplasms, Endometrial Cancer
Symbiotic-GYN-18: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Advanced or Recurrent MMR-proficient Endometrial Cancer
This study is being conducted to assess whether the study medicine PF 08634404, given in combination with chemotherapy, improves outcomes compared with another medicine called pembrolizumab plus chemotherapy.
- Trial name
- NCT07578649
- Testing
- PF-08634404, Pembrolizumab, Standard of Care Chemotherapy
- Where
- 43 sites in United States, Australia and 2 more
- Volunteers
- 600 people
- Sponsor
- Pfizer
Food-drug Interaction
Licorice Botanical Dietary Supplements - Metabolism and Safety in Women
Human safety studies will be carried out to test whether red clover botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs.
- Trial name
- NCT03948243
- Testing
- Licorice, Alprazolam 2 MG, Caffeine 100 MG
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- University of Illinois at Chicago
Non-Small Cell Lung Cancer
The Efficacy and Safety of Apatinib in Heavily Pretreated Advanced Non-squamous Non-small Cell Lung Cancer
The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer treatments. Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor…
- Trial name
- NCT02515435
- Testing
- apatinib single agent
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Tongji University
Epilepsy, Complex Partial
Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.
- Trial name
- NCT00056576
- Testing
- Zonisamide
- Where
- 35 sites in United States, Estonia and 3 more
- Volunteers
- 165 people
- Sponsor
- Eisai Inc.
Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors
Pharmacokinetics, Safety, and Efficacy of Brigatinib Monotherapy in Pediatric and Young Adult Participants With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors
The purpose of this study is to estimate the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) regimen and characterize the pharmacokinetics (PK) of brigatinib monotherapy (film-coated tablets and age-appropriate…
- Conditions
- Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors, Solid Tumors
- Trial name
- NCT04260009
- Testing
- Brigatinib, Brigatinib AAF
- Sponsor
- Takeda
Peptic Ulcer Disease
Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases
This trial aims to determine whether Jiangzhong Hou Gu® Mi Xi™ is an effective intervention to improve symptoms and indicators in patients with spleen qi deficiency and peptic ulcer diseases.
- Trial name
- NCT03320538
- Testing
- Hou Gu Mi Xi, Rabeprazole
- Where
- China
- Volunteers
- 360 people
- Sponsor
- Jiangxi University of Traditional Chinese Medicine
Advanced KRAS G12D Mutant Solid Tumors
A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
The study is being conducted to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with antitumor medicine in patients with advanced solid tumors harboring KRAS G12D mutation.
- Trial name
- NCT06385678
- Testing
- HRS-4642, Adebrelimab, SHR-9839
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Diffuse, Large B-Cell, Lymphoma
Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a…
- Trial name
- NCT02391116
- Testing
- Copanlisib (Aliqopa, BAY80-6946)
- Where
- 32 sites in Australia, Belgium and 8 more
- Volunteers
- 67 people
- Sponsor
- Bayer
Light Chain (AL) Amyloidosis
An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis
This is a Phase 1 open-label, dose escalation trial designed to identify the recommended phase 2 dose of STI-6129 by assessing the safety, preliminary efficacy, and immunogenicity in subjects with relapsed or refractory systemic…
- Trial name
- NCT05692908
- Testing
- STI-6129
- Sponsor
- Sorrento Therapeutics, Inc.
Graft Occlusion, Vascular, Coronary Restenosis
A Blinded Study Conducted at Multiple Centers Evaluating Various Doses of an Investigational Agent (BO-653) Against Placebo, for Safety and Effectiveness in Preventing Post-Angioplasty Blood Vessel Re-Closure (Restenosis) in Stented Vessels.
This research study is intended to evaluate the safety and effectiveness of 3 different doses of BO-653, an investigational inhibitor of LDL cholesterol oxidation, when given orally twice a day compared to placebo (an inactive…
- Conditions
- Graft Occlusion, Vascular, Coronary Restenosis, Atherosclerosis
- Trial name
- NCT00055510
- Testing
- BO-653
- Where
- 29 sites in United States
- Sponsor
- Chugai Pharma USA
Relapsing-remitting Multiple Sclerosis
Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis
The objective of the clinical study of the medicinal product for medical use: to compare efficacy and safety of the generic drug BCD-063 and Copaxone®-Teva in patients with relapsing-remitting multiple sclerosis.
- Trial name
- NCT02753088
- Testing
- BCD-063, Copaxone-Teva
- Volunteers
- 158 people
- Sponsor
- Biocad
Bifurcation Lesions, Drug Eluting Balloon
Bingo Drug-eluting Balloon in Bifurcation
The purpose is to observe and evaluate the safety and efficacy of Bingo drug-eluting balloon in the treatment of patients with bifurcation lesions of coronary artery.
- Trial name
- NCT02325817
- Testing
- Drug-eluting balloon, Uncoated ballloon
- Where
- China
- Volunteers
- 222 people
- Sponsor
- Yinyi(Liaoning) Biotech Co., Ltd.
Healthy
A Study to Assess the Safety and Immunogenicity of the Drug CAT-354 in Healthy Japanese Subjects
To assess the safety of the administration of the drug (CAT-354) in healthy Japanese subjects.
- Trial name
- NCT01093040
- Testing
- CAT-354, CAT 354
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Still's Disease Adult Onset
An Efficacy and Safety Study of GNR-086 (Canakinumab Biosimilar) and Ilaris® in Patients With Adult-onset Still's Disease
This is a randomized single-blind comparative parallel group study of the efficacy and safety of canakinumab biosimilar GNR-086 (JSC \"GENERIUM\", Russia) and Ilaris® (Novartis Pharma Stein AG, Switzerland) in the…
- Trial name
- NCT06497491
- Testing
- GNR-086, Ilaris®
- Where
- 17 sites in Russia
- Volunteers
- 118 people
- Sponsor
- AO GENERIUM