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NCT ID: NCT03326674 Terminated - Breast Cancer Clinical Trials

Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC

CONTESSA
Start date: December 21, 2017
Phase: Phase 3
Study type: Interventional

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). 685 patients were enrolled.

NCT ID: NCT03315143 Terminated - Heart Failure Clinical Trials

Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

SCORED
Start date: December 19, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.

NCT ID: NCT03286582 Terminated - Bullous Pemphigoid Clinical Trials

A Proof-of-Concept Study of Topical AC-203 in Patients With Bullous Pemphigoid

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

Bullous pemphigoid (BP) is a chronic, inflammatory, subepidermal, autoimmune blistering disease which mainly develops in the elderly, with onset usually in the late 70s and a substantial increase in incidence in people older than 80 years. If untreated, it can persist for months or years, with periods of spontaneous remissions and exacerbations. It has been found that blisters and sera of BP patients contain abnormally high levels of pro-inflammatory cytokines such as interleukin-6 (IL-6) and IL-8. Recently, it also has been demonstrated that NLRP3 (NACHT, LRR and PYD domains-containing protein 3) inflammasome components (the NLRP3-caspase-1-IL-18 axis) were significantly up-regulated in peripheral blood mononuclear cells from BP patients and positively correlated with disease activity. AC-203 is a topical formulation of an oral modulator of inflammasome and IL-1beta pathways. In vitro studies have demonstrated that AC-203 significantly reduced secretion of IL-6 and moderately reduced IL-8 secretion in HaCaT cells treated with specific anti-BP180 IgG. This study is designed to test the safety, tolerability, efficacy, and pharmacokinetics of AC-203 ointment (vs. a topical steroid comparator representing standard of care) ointment in subjects with BP.

NCT ID: NCT03275376 Terminated - Overall Survival Clinical Trials

Statin Combination Therapy in Patients Receiving Sorafenib for Advanced Hepatocellular Carcinoma

Start date: December 21, 2017
Phase: Phase 2
Study type: Interventional

Target therapy with sorafenib is the standard of treatment for advanced Hepatocellular carcinoma (HCC), but the patient survival time is still unsatisfactory. The aims of this study are to prove statins improve the tumor responses and overall survival for patients who receive sorafenib therapy for advanced HCC by a prospective randomized controlled study.

NCT ID: NCT03256331 Terminated - Clinical trials for Advanced Solid Tumors

Evaluate the Safety of BEL-X-HG in Advanced Cancer Patients

Start date: June 21, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, uncontrolled, multicenter dose escalation and extension study to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate safety / tolerability and preliminary effects of BEL-X-HG in patients with advanced refractory solid tumors. Dose escalation during the study will be made based on dose-limiting toxicity (DLT).

NCT ID: NCT03255083 Terminated - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer

Start date: April 10, 2019
Phase: Phase 1
Study type: Interventional

This study has two parts: dose escalation and dose expansion. The primary objectives are: - For Dose Escalation, to assess the safety and tolerability of DS-1205c when combined with osimertinib in the study population and to determine the recommended dose for expansion of DS-1205c when combined with osimertinib in the study population - For Dose Expansion, to assess the safety and tolerability of DS-1205c when combined with osimertinib in the study population In Dose Escalation, after a 7-day run in period (Cycle 0), there will be 21-day cycles (Cycle 1 onward). In Dose Expansion, there will be 21-day cycles. The number of treatment cycles is not fixed in this study. Participants will continue study treatment until they decide not to (withdraw consent), their disease gets worse [progressive disease (PD)], or side effects become unacceptable (unacceptable toxicity).

NCT ID: NCT03254732 Terminated - Clinical trials for Advanced Solid Cancers

Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

Start date: July 14, 2017
Phase: Phase 1
Study type: Interventional

This is a phase 1b, open label trial of ADI-PEG 20 (36 mg/m2) weekly in combination with pembrolizumab (1 and 2 mg/kg or 200 mg) every three weeks. Assessment of safety and tolerability of drug combination

NCT ID: NCT03253991 Terminated - Essential Tremor Clinical Trials

A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor

Start date: November 17, 2014
Phase: N/A
Study type: Interventional

A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects The objective of this prospective, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor inpatients with essential tremor (ET). The Indications for Use claim for this system is as follows: Treatment of medication-refractory tremor in patients with essential tremor.

NCT ID: NCT03252834 Terminated - Clinical trials for Chemotherapy-induced Abnormal Thermal Sensation

Genetic Variants and Chemotherapy-induced Abnormal Thermal Sensation

Start date: July 1, 2017
Phase:
Study type: Observational

This is a prospective, single arm, single center study evaluating the use of a 4-gene panel to predict the occurrence of chemotherapy-induced abnormal thermal threshold in endometrial and ovarian cancer patients receiving post-operative chemotherapy with Carboplatin/Paclitaxel, and stage III colorectal cancer patients receiving adjuvant chemotherapy with mFOLFOX6. A total of 100 patients will be enrolled during 2017 July~ 2019 June. Blood sample will be collected before chemotherapy to analyze the genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1. All patients will receive neurologic examination (Quantitative Sensory Test, QST) and complete the questionnaires for quality of life (EQ5D & CIPN20). The primary endpoint of this study is to test if the genetic variant of TRPV1, TRPM2, TRPA1, and ORAI1 is a predictive biomarker for the chemotherapy-induced abnormal thermal sensation in cancer patients.

NCT ID: NCT03246854 Terminated - Clinical trials for Head and Neck Cancer

A Study of DBPR112 in Patients With Head and Neck Cancer and EGFR Mutated Lung Cancer

Start date: July 18, 2017
Phase: Phase 1
Study type: Interventional

The study is being performed to assess the MTD, pharmacokinetics (PK), safety, tolerability and preliminary antitumor activity of DBPR112 in patients with head and neck cancer and EGFR mutated lung cancer.