Clinical trials: Gene Mutation
Nicotine Dependence, Cigarettes, Uncomplicated
Impact of Nicotine Reduction on Adolescent Cigarette Use, Alternative Tobacco Use, and Harm From Tobacco
Adolescents are an important vulnerable population to consider as the FDA moves toward a nicotine reduction policy. Such a policy, which would mandate a reduction of nicotine in all commercially available cigarettes, has the…
- Trial name
- SIREN (NCT03860077)
- Testing
- Very Low Nicotine Content Cigarettes, Normal Nicotine Content Cigarettes
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Brown University
Advanced Breast Cancer
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or…
- Trial name
- ALPINIST (NCT05631795)
- Testing
- Alpelisib, Fulvestrant
- Where
- 12 sites in India
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Leber Congenital Amaurosis 10, Blindness
Extension Study to Study PQ-110-001 (NCT03140969)
Subjects completing participation in study PQ-110-001 (EudraCT 2017-000813-22 / NCT03140969) will be given the opportunity to enroll into the extension study for continued dosing if available data support current and/or future…
- Conditions
- Leber Congenital Amaurosis 10, Blindness, Leber Congenital Amaurosis, Vision Disorders
- Trial name
- INSIGHT (NCT03913130)
- Testing
- QR-110
- Where
- 3 sites in United States, Belgium
- Volunteers
- 9 people
- Sponsor
- Laboratoires Thea
Irritable Bowel Syndrome (IBS), Functional Abdominal Pain
Peer Mentorship: An Intervention To Promote Effective Pain Self-Management In Adolescents
This protocol matches child subjects with peer mentors of similar age who have learned to function successfully with a chronic pain disorder.
- Conditions
- Irritable Bowel Syndrome (IBS), Functional Abdominal Pain, Fibromyalgia, Complex Regional Pain Syndrome (CRPS)
- Trial name
- NCT01118988
- Testing
- Mentorship
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- University of California, Los Angeles
Recurrent Breast Carcinoma, Stage IIIB Breast Cancer
Akt Inhibitor MK2206 in Treating Patients With Advanced Breast Cancer
This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with breast cancer cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment.
- Conditions
- Recurrent Breast Carcinoma, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
- Trial name
- NCT01277757
- Testing
- Akt Inhibitor MK2206, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- National Cancer Institute (NCI)
C3 Glomerulonephritis, Dense Deposit Disease
A Proof-of-Mechanism Study to Determine the Effect of Danicopan on C3 Levels in Participants With C3G or IC-MPGN
The primary objective of this study was to determine whether ACH-0144471 (also known as danicopan and ALXN2040) increases blood C3 complement protein (C3) levels in participants with low C3 levels due to either C3G or IC-MPGN.
- Conditions
- C3 Glomerulonephritis, Dense Deposit Disease, C3 Glomerulopathy, Immune Complex Mediated Membranoproliferative Glomerulonephritis
- Trial name
- NCT03124368
- Testing
- Danicopan
- Where
- 3 sites in Australia, Belgium and 1 more
- Volunteers
- 6 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Non-small Cell Lung Cancer
Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT)
This is a multi-center, open-label, randomized, Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free survival (PFS) of Tepotinib when used in combination with…
- Trial name
- NCT01982955
- Testing
- Tepotinib, Gefitinib, Pemetrexed
- Where
- 44 sites in China, Italy and 5 more
- Volunteers
- 88 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Depression, Depressive Disorder
Electroacupuncture for Major Depression
This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression.
- Trial name
- NCT00071110
- Testing
- Electroacupuncture
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- National Center for Complementary and Integrative Health (NCCIH)
Hypercholesterolemia
A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Gene or Loss-of-Function Mutations (LOFm) of the Apolipoprotein (Apo) B Gene
The primary objective of the study is to assess the pharmacodynamic (PD) effect of alirocumab on serum low density lipoprotein cholesterol (LDL-C) during 14 weeks of subcutaneous (SC) administered alirocumab in patients with…
- Trial name
- NCT01604824
- Testing
- Alirocumab
- Where
- 4 sites in United States, France
- Volunteers
- 23 people
- Sponsor
- Regeneron Pharmaceuticals
High Tumor Mutation Burden, High TMB (Tumor Mutation Burden)
Study of MK-3475 (Pembrolizumab) in Patients With Microsatellite Unstable (MSI) Tumors (Cohort D)
This study will be looking at whether MK-3475 (pembrolizumab) is effective (anti-tumor activity) and safe in patients with MSI (Microsatellite Unstable) negative cancer with a mutator phenotype.
- Conditions
- High Tumor Mutation Burden, High TMB (Tumor Mutation Burden), MSS (Microsatellite Stable)
- Trial name
- NCT04098068
- Testing
- MK-3475
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Oncology, MET Gene Amplification
Sym015 (Anti-MET) in Patients With Advanced Solid Tumor Malignancies
This is the first study to test Sym015 in humans. The primary purpose of this study is to see if Sym015 is safe and effective for patients with advanced solid tumor malignancies without available therapeutic options.
- Conditions
- Oncology, MET Gene Amplification, NSCLC, MET Gene Mutation
- Trial name
- NCT02648724
- Testing
- Sym015
- Where
- 27 sites in United States, Denmark and 4 more
- Volunteers
- 57 people
- Sponsor
- Symphogen A/S
Advanced Cancers
Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients
The goal of this clinical research study is to learn if temsirolimus can help to control advanced cancer in patients who also have a PI3K mutation and/or PTEN loss. The safety of this drug will also be tested.
- Trial name
- NCT00877773
- Testing
- Temsirolimus
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- M.D. Anderson Cancer Center
Cystic Fibrosis
A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation
The study will evaluate the impact of smart adherence technology for monitoring on lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with Cystic Fibrosis (CF) who are homozygous for the…
- Trial name
- NCT02823470
- Testing
- LUM/IVA, activated smart device, de-activated smart device
- Where
- 11 sites in United States, Canada
- Volunteers
- 24 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Childhood Obesity
Obesity Prevention in Head Start
Family style dining is a widely-advocated approach by which to feed children in early education settings. While family-style dining is hypothesized to allow children to attend to their hunger and satiety and consume only the…
- Trial name
- NCT03672227
- Testing
- Mealtime Matters Training
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Leber's Congenital Amaurosis
Study to Evaluate QR-110 in Leber's Congenital Amaurosis (LCA) Due to the c.2991+1655A>G Mutation (p.Cys998X) in the CEP290 Gene
The purpose of this study is to evaluate the safety and tolerability of QR-110 administered via intravitreal injection in subjects with LCA due to the CEP290 p.Cys998X mutation.
- Trial name
- NCT03140969
- Testing
- QR-110
- Where
- 3 sites in United States, Belgium
- Volunteers
- 11 people
- Sponsor
- Laboratoires Thea
Asthma
Asthma Clinical Research Network (ACRN) Trial - Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC)
Typically, people with asthma are initially prescribed a low dose of inhaled corticosteroid (ICS) medication to control asthma symptoms.
- Trial name
- TALC (NCT00565266)
- Testing
- tiotropium bromide, salmeterol xinafoate, beclomethasone dipropionate
- Where
- 10 sites in United States
- Volunteers
- 210 people
- Sponsor
- Milton S. Hershey Medical Center
Malignant Melanoma
A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma
This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E…
- Trial name
- NCT01264380
- Testing
- RO5185426
- Where
- 10 sites in United States
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
Neoplasms, Solid Tumors
My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors
This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available…
- Conditions
- Neoplasms, Solid Tumors, Biliary Cancer, Salivary Cancer
- Trial name
- NCT02091141
- Testing
- Trastuzumab, Pertuzumab, Erlotinib
- Where
- 60 sites in United States
- Volunteers
- 673 people
- Sponsor
- Genentech, Inc.
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes
The purpose of this study is to test the good and bad effects of an experimental drug called SF1126. This drug is being tested in patients whose cancer has not been controlled by available standard therapies and who have certain…
- Trial name
- NCT02644122
- Testing
- SF1126
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Ezra Cohen
Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis
Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis
The purpose of this study was to evaluate the effect of an alternative dosing strategy of ruxolitinib in subjects with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) and post essential…
- Conditions
- Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis
- Trial name
- NCT01445769
- Testing
- Ruxolitinib
- Where
- 21 sites in United States
- Volunteers
- 45 people
- Sponsor
- Incyte Corporation