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NCT ID: NCT02959437 Terminated - Solid Tumors Clinical Trials

Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)

Start date: February 27, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, Phase 1/2 study in subjects with advanced or metastatic solid tumors. The study has three separate treatment groups where separate epigenetic agents are evaluated with an immunotherapy combination. Treatment Group A will evaluate the DNA methyltransferase inhibitor azacitidine in combination with the programmed death receptor-1 (PD-1) inhibitor pembrolizumab and the indoleamine 2,3-dioxygenase (IDO-1) inhibitor epacadostat; Treatment Group B will evaluate the bromodomain and extra-terminal (BET) inhibitor INCB057643 with pembrolizumab and epacadostat; and Treatment Group C will evaluate the lysine-specific demethylase 1A (LSD1) inhibitor INCB059872 with pembrolizumab and epacadostat. The study will be divided into 2 parts (Part 1 and 2). Part 1 is a dose-escalation assessment to evaluate the safety and tolerability of the combination therapies. Once the recommended doses have been determined, subjects with previously treated NSCLC, microsatellite-stable colorectal cancer (CRC), head and neck squamous cell carcinoma, urothelial carcinoma, and melanoma will be enrolled into expansion cohorts in Part 2.

NCT ID: NCT02958917 Terminated - Clinical trials for Interstitial Lung Disease

Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis

Start date: June 5, 2017
Phase: Phase 2
Study type: Interventional

Patients are being offered participation in this pirfenidone trial because They have been diagnosed with fibrotic hypersensitivity pneumonitis (FHP), a type of interstitial lung disease (ILD). This is a disease where scarring of lung tissue occurs as the result of inhaling substances called antigens. These antigens can be substances such as molds, chemicals or dust. As a result of this scarring the lungs are is not able to move oxygen into the bloodstream to reach other organs. Currently over 1400 subjects have been treated with pirfenidone in 15 clinical trials. This drug has been approved by the Food and Drug Administration (FDA) for use in Idiopathic Pulmonary Fibrosis, a different type of ILD, but requires special permission for use in your condition. The use of pirfenidone has not been approved for the treatment of FHP. It is considered experimental treatment in this study.

NCT ID: NCT02956486 Terminated - Alzheimer's Disease Clinical Trials

A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Participants With Early Alzheimer's Disease

MissionAD1
Start date: October 20, 2016
Phase: Phase 3
Study type: Interventional

The name of this trial is MissionAD1. This phase 3 study consists of a Core and Open Label Extension (OLE) Phase in participants with Early Alzheimer's Disease (EAD), and will be conducted to evaluate the efficacy and safety of E2609. The Core is a 24-month treatment, multicenter, double blind, placebo controlled parallel group study. The OLE is a 24-month treatment, one group study. The data for the studies E2609-G000-301 (NCT02956486, MissionAD1) and E2609-G000-302 (NCT03036280, MissionAD2) will be pooled.

NCT ID: NCT02956122 Terminated - Clinical trials for Graft Versus Host Disease

A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD

Start date: April 26, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of GLASSIA as an add-on biopharmacotherapy to standard-of-care steroid treatment as the first-line treatment in participants with acute GvHD with lower GI involvement.

NCT ID: NCT02956005 Terminated - Clinical trials for Renal Transplant Recipients

Envarsus XR in African American Renal Transplant Recipients

EXR
Start date: September 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to collect data prospectively on African American patients who are taking the immunosuppressant Envarsus post kidney transplant. We are looking to see if African American renal transplant recipients that receive Envarsus will have less tubular injury and calcenurin inhibitor toxicity compared with patients that receive tacrolimus IR. African americans have the higher rates of CYP3A5 which is associated with the need of higher tacrolimus dose to achieve an adequate level and this many times is associated with signs and symptoms of tacrolimus toxicity such as tremors, headaches and neuropathies. The retrospective cohort will be African American patients that will be matched by age, gender, type of kidney transplant (living vs deceased) and level of sensitization

NCT ID: NCT02955511 Terminated - Anesthesia Clinical Trials

Comparison of 3 Direct Laryngoscopes for Tracheal Intubation in Patients Undergoing Lumbar Spine Surgery

Start date: January 2, 2018
Phase: N/A
Study type: Interventional

Hypothesis The use of Macintosh blade sized #3.5 (vs Macintosh size #3) would reduce the time required to achieve successful tracheal intubation and improve the glottic view. Study objective The purpose of this research study is to compare 3 different laryngoscope blades (sizes: 3.5, 3.5 and 3) and see if the blades size 3.5 will reduce the time required to achieve successful tracheal intubation and improve the physician's view of the glottis compared to the standard direct laryngoscope using the blade size 3, in patients undergoing lumbar surgery. Primary end point: time to achieve successful tracheal intubation. Secondary end points: glottic view at intubation, number of intubation attempts and effectiveness of the integrated suction in the Inscope Direct Laryngoscope.

NCT ID: NCT02955381 Terminated - Acne Clinical Trials

Restylane Silk Acne Scar Efficacy Evaluation Study

Start date: March 28, 2017
Phase: N/A
Study type: Interventional

Randomized, double-blind, placebo-controlled, research pilot study. 30 subjects aged 22-55 years old of all skin types will be asked to sign an informed consent form prior to any study procedures. Subjects must have at least 1 but up to 3 acne scars ≥3 mm or ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk or Placebo) in each scar at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will be asked to come to 10 visits: Screening visit (up to 35 days prior to Baseline), Baseline (Day 0), Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6 (study exit visit). The treatment area will be evaluated at each visit by the unblinded investigator regarding erythema, bruising, inflammation, itching, stinging/burning, brightness, fullness, smoothness, and clarity. Safety and adverse events will be captured at each visit only by the unblinded investigator.

NCT ID: NCT02955147 Terminated - Clinical trials for Giant Cell Arteritis

Ustekinumab for the Treatment of Giant Cell Arteritis

UGCA
Start date: December 1, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether ustekinumab is effective in the treatment of Giant Cell Arteritis (GCA)

NCT ID: NCT02955121 Terminated - Clinical trials for Coronary Artery Disease

IU Health Krannert Personalized Medicine Study

Start date: November 2016
Phase: N/A
Study type: Interventional

Randomized controlled study to examine physician use of pharmacogenetic information in patients receiving antiplatelet medication after percutaneous coronary intervention (PCI).

NCT ID: NCT02954991 Terminated - Clinical trials for Carcinoma, Non-Small-Cell Lung

Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer

Start date: November 7, 2016
Phase: Phase 2
Study type: Interventional

The study will evaluate the clinical activity of nivolumab in combination with 3 separate investigational agents, glesatinib, sitravatinib, or mocetinostat.