Clinical trials: Response Inhibition
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
Non-small Cell Lung Cancer
Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC
This study was planned to determine if neoadjuvant capmatinib could improve the major pathological response (MPR) in patients with Stage IB-IIIA, N2 and selected IIIB (T3N2 or T4N2) lung cancers with Mesenchymal Epithelial…
- Trial name
- Geometry-N (NCT04926831)
- Testing
- capmatinib
- Where
- 6 sites in United States
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis, Systemic Lupus Erythematosus
A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis
This was a Phase 1b/2, multi-center study in which patients received KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).
- Trial name
- MISSION (NCT03393013)
- Testing
- KZR-616
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 69 people
- Sponsor
- Kezar Life Sciences, Inc.
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL
This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Trial name
- NCT02337829
- Testing
- Acalabrutinib (Arm A), Acalabrutinib (Arm B)
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Acerta Pharma BV
Chronic Plaque Psoriasis
Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis
- Trial name
- DERMIS-OLE (NCT04286607)
- Testing
- Topical roflumilast
- Where
- 85 sites in United States, Canada and 1 more
- Volunteers
- 337 people
- Sponsor
- Arcutis Biotherapeutics, Inc.
Septic Shock
Treatment of Septic Shock by Inhibiting Autodigestion and Preserving Gut Integrity With Enteric LB1148
Septic shock is a potentially life-threatening condition that can result in multi-organ dysfunction syndrome (MODS) and mortality.
- Trial name
- SSAIL (NCT02317549)
- Testing
- LB1148
- Where
- 34 sites in United States, Canada
- Volunteers
- 8 people
- Sponsor
- Leading BioSciences, Inc
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited
Atopic Dermatitis Eczema
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)
This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema).
- Trial name
- NCT04773600
- Testing
- Roflumilast Cream, Vehicle cream
- Where
- 53 sites in United States, Canada
- Volunteers
- 683 people
- Sponsor
- Arcutis Biotherapeutics, Inc.
Non-tuberculous Mycobacterial Diseases, Tuberculosis
Safety And Efficacy Of Rifabutin In HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Conditions
- Non-tuberculous Mycobacterial Diseases, Tuberculosis, Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
- Trial name
- NCT00810446
- Testing
- rifabutin
- Volunteers
- 72 people
- Sponsor
- Pfizer
Hypercholesterolemia, Familial
Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study
The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in adults with heterozygous familial…
- Trial name
- RUTHERFORD (NCT01375751)
- Testing
- Evolocumab
- Volunteers
- 168 people
- Sponsor
- Amgen
Paroxysmal Nocturnal Hemoglobinuria
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition
This study will enroll participants aged 12 years or older with a body weight ≥ 40 kilograms (kg) diagnosed with PNH who have not been previously treated with complement inhibitor therapy.
- Trial name
- COMMODORE 3 (NCT04654468)
- Testing
- Crovalimab
- Where
- 5 sites in China
- Volunteers
- 51 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
Evaluation of Effect of Vonoprazan on Midazolam Pharmacokinetics in Healthy Participants
To determine the time-dependent inhibition potential of repeated doses of oral vonoprazan on the pharmacokinetics (PK) of a single oral dose of midazolam, a sensitive cytochrome P450 3A4 (CYP3A4) substrate, in healthy…
- Trial name
- NCT04545944
- Testing
- Vonoprazan, Midazolam
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Phathom Pharmaceuticals, Inc.
Atopic Dermatitis Eczema
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
This was a Phase 3, 4-week, double-blind study to assess the safety and efficacy of ARQ-151 cream compared to vehicle cream applied once daily (qd) for 4 weeks in children 2 to 5 years of age with atopic dermatitis (AD).
- Trial name
- NCT04845620
- Testing
- Roflumilast Cream 0.05%, Vehicle Cream
- Where
- 76 sites in United States, Canada
- Volunteers
- 652 people
- Sponsor
- Arcutis Biotherapeutics, Inc.
Stage IV Melanoma, Metastatic Melanoma
Immunotherapy Study for Patients With Stage IV Melanoma
The purpose of this study is to examine the effectiveness of immune checkpoint inhibitors (drugs called ipilimumab, nivolumab, or pembrolizumab), either given alone, or in combination with the experimental immunotherapy drug…
- Trial name
- NCT02054520
- Testing
- HyperAcute®-Melanoma (HAM) Immunotherapy, Ipilimumab, Pembrolizumab
- Where
- 5 sites in United States
- Volunteers
- 47 people
- Sponsor
- NewLink Genetics Corporation
Diabetes Mellitus, Type 2, Coronary Artery Disease
Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD
The purpose of this study is to determine whether bromodomain extraterminal domain (BET) inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with coronary artery disease increases the time to major…
- Trial name
- BETonMACE (NCT02586155)
- Testing
- Apabetalone, Atorvastatin, Rosuvastatin
- Where
- 214 sites in Argentina, Australia and 13 more
- Volunteers
- 2,425 people
- Sponsor
- Resverlogix Corp
Myocardial Ischemia, Acute Coronary Syndrome
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention…
- Trial name
- NCT00089895
- Testing
- Eptifibatide (Integrilin)
- Volunteers
- 9,406 people
- Sponsor
- Organon and Co
Hyperlipidemia
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a…
- Trial name
- LAPLACE (NCT01380730)
- Testing
- Evolocumab
- Where
- 100 sites in United States, Canada and 3 more
- Volunteers
- 631 people
- Sponsor
- Amgen
Heterozygous Familial Hypercholesterolemia
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
- Trial name
- HAUSER-RCT (NCT02392559)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Australia and 24 more
- Volunteers
- 158 people
- Sponsor
- Amgen
Healthy Volunteers
A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers.
- Trial name
- NCT03774576
- Testing
- RO7017773, Itraconazole
- Where
- France
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Neoplasms
Investigational Agent AG-013736 In Combinations With Standard Of Care Treatments For Patient's With Advanced Solid Tumor
To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.
- Trial name
- NCT00454649
- Testing
- Axitinib + Paclitaxel + Carboplatin (Cohort 1), Axitinib + Paclitaxel + Carboplatin (Cohort 2), Axitinib + Paclitaxel + Carboplatin (Cohort 3)
- Where
- 13 sites in United States, Poland and 1 more
- Volunteers
- 102 people
- Sponsor
- Pfizer