Clinical trials: Biological Markers
Lymphangioleiomyomatosis
Discovery of Sirolimus Sensitive Biomarkers in Blood
Background: Lymphangioleiomyomatosis (LAM) is a rare, progressive disease. It usually affects women in the prime of their lives. It typically results in lung destruction.
- Trial name
- NCT03304678
- Testing
- Sirolimus 2mg
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Device Latency
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02404532)
- Testing
- MIND1 System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Relapse Remitting Multiple Sclerosis
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes.
- Trial name
- AGNOS (NCT05084638)
- Testing
- Ofatumumab
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Bladder Carcinoma
TracelT Hydrogel in Localizing Bladder Tumors in Patients Undergoing Radiation Therapy for Bladder Cancer
This pilot clinical trial studies how well TracelT hydrogel works in localizing bladder tumors in patients undergoing radiation therapy for bladder cancer.
- Trial name
- NCT03125226
- Testing
- Polyethylene Glycol Hydrogel
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Washington
Rheumatoid Arthritis
A Study of LY2127399 in Rheumatoid Arthritis
This study will investigate how LY2127399 works in participants with rheumatoid arthritis (RA) who are not adequately responding to methotrexate.
- Trial name
- NCT01576549
- Testing
- LY2127399
- Where
- 4 sites in United States
- Volunteers
- 2 people
- Sponsor
- Eli Lilly and Company
Amyotrophic Lateral Sclerosis
The Effect of RNS60 on ALS Biomarkers
Amyotrophic Lateral Sclerosis (ALS) is a rare lethal neurodegenerative disease involving inflammation. Riluzole, the only drug for ALS, improves median survival by 3 months. This prompts new treatments of ALS.
- Trial name
- RNS60 (NCT03456882)
- Testing
- RNS60
- Where
- 23 sites in United States, Italy
- Volunteers
- 147 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Non-Squamous Non-Small Cell Lung Cancer
A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC)
This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy.
- Trial name
- MERIT (NCT02774278)
- Testing
- Erlotinib
- Where
- 29 sites in Belgium, Bulgaria and 12 more
- Volunteers
- 264 people
- Sponsor
- Hoffmann-La Roche
FGFR Inhibition, Pharmacokinetics, Biomarkers, ER+ Breast Cancer
Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients
The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)
- Trial name
- GLOW (NCT01202591)
- Testing
- AZD4547, Exemestane, Fulvestrant
- Where
- 21 sites in Belgium, Czechia and 6 more
- Volunteers
- 127 people
- Sponsor
- AstraZeneca
Churg-Strauss Syndrome
A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram [mg] administered subcutaneously [SC] every 4 weeks) compared with placebo over a 52-week study treatment…
- Trial name
- NCT02020889
- Testing
- Mepolizumab
- Where
- 32 sites in United States, Belgium and 7 more
- Volunteers
- 136 people
- Sponsor
- GlaxoSmithKline
Rheumatoid Arthritis
Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients
This proposal will evaluate if musculoskeletal ultrasound (MSUS) measures or multi-biomarker disease activity (MBDA) improve in patients treated with tofacitinib over 3 months, and whether early MSUS measures/MBDA can predict…
- Trial name
- NCT02321930
- Testing
- tofacitinib 5mg po bid
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- University of California, Los Angeles
Parkinson Disease, Parkinsons Disease With Dementia
Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease
Parkinson's disease (PD) is the second most common neurodegenerative disorder causing motor and non-motor symptoms. PD is characterized by death of dopaminergic (DA) neurons in the substantia nigra (SN) pars compacta and…
- Trial name
- PD Nilotinib (NCT02954978)
- Testing
- Nilotinib 150mg oral capsule [Tasigna], Nilotinib 300mg oral capsule [Tasigna]
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Georgetown University
Generalized Anxiety Disorder, Separation Anxiety Disorder
Treatment of Pediatric Anxiety Disorders by Predicting Treatment Response Through Biocellular Markers and Sleep
1 out of 8 children, adolescents, and young adults suffer from an anxiety disorder. Studies over the past decade show that selective serotonin-reuptake inhibitors (SSRIs), a class of medication that treats anxiety in adults, also…
- Conditions
- Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia
- Trial name
- NCT02189213
- Testing
- Sertraline
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Drug-drug Interaction Study
A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin
The goal of this clinical study was to determine the effect of the test drug ceftobiprole (a drug approved for the treatment of bacterial infections) on the elimination of pitavastatin (a drug approved for the treatment of…
- Trial name
- NCT06808646
- Testing
- pitavastatin, pitavastatin single dose combined with ceftobiprole
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Amyloidosis
Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698
The study is intended to evaluate whether monthly repeated courses of administration of GSK2315698 followed by GSK2398852 is associated with a reduction in cardiac amyloid load in patients with cardiac amyloidosis, monitored by…
- Trial name
- NCT03044353
- Testing
- GSK2315698 (CPHPC), GSK2398852 (anti-SAP mAb)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 7 people
- Sponsor
- GlaxoSmithKline
Colon Adenocarcinoma, Stage IIA Colon Cancer AJCC v8
Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery
This phase II/III trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) testing in the blood works in predicting treatment for patients with stage IIA colon cancer after surgery.
- Trial name
- NCT04068103
- Testing
- Capecitabine, Fluorouracil, Leucovorin
- Where
- 957 sites in United States, Canada and 1 more
- Volunteers
- 635 people
- Sponsor
- NRG Oncology
Growth Hormone Deficiency
Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)
This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects…
- Trial name
- OraGrowtH210 (NCT04614337)
- Testing
- LUM-201, rhGH Norditropin® pen (34 µg/kg)
- Where
- 43 sites in United States, Australia and 4 more
- Volunteers
- 104 people
- Sponsor
- Lumos Pharma
Autism
Validation of Indiana's Early Evaluation Hub System
The investigators' objective is to test an innovative method of autism diagnosis that integrates clinical evaluation and assessment of biobehavioral markers in a large high-risk community-referral sample of children in the…
- Trial name
- EAER21 (NCT06586788)
- Testing
- Eyelink Portable Duo, Integrated PCP Diagnosis and Eye-tracking Biomarker
- Where
- 7 sites in United States
- Volunteers
- 154 people
- Sponsor
- Indiana University
Metastatic Breast Cancer
Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer
This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally…
- Trial name
- NCT01663727
- Testing
- Bevacizumab [Avastin], Paclitaxel
- Where
- 178 sites in United States, Argentina and 14 more
- Volunteers
- 481 people
- Sponsor
- Hoffmann-La Roche
Tobacco Use
Changes in Biomarker of Exposure in Adults Who Smoke Cigarettes Switching From Cigarettes to Heated Tobacco Products
The purpose of the study is to evaluate changes in biomarkers of exposure (BoE) to harmful and potentially harmful constituents (HPHCs) in adult smokers who completely switch to Ploom heated tobacco products (HTPs) compared to…
- Trial name
- NCT06179290
- Testing
- Ploom HTP Menthol HTS; MX3 (681), Ploom HTP Tobacco HTS; R8 (120), Smoking Abstinence (menthol)
- Where
- 8 sites in United States
- Volunteers
- 921 people
- Sponsor
- Altria Client Services LLC
Acute Myeloid Leukemia
Alvocidib Biomarker-driven Phase 2 AML Study
The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) of ACM (Alvocidib/Cytarabine/Mitoxantrone) compared to CM (Cytarabine/Mitoxantrone) treatment in refractory or relapsed AML…
- Trial name
- NCT02520011
- Testing
- Alvocidib, Cytarabine, Mitoxantrone
- Where
- 38 sites in United States, Canada and 2 more
- Volunteers
- 104 people
- Sponsor
- Sumitomo Pharma America, Inc.