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NCT ID: NCT02213042 Terminated - Neoplasms, Breast Clinical Trials

Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer

Start date: October 24, 2014
Phase: Phase 2
Study type: Interventional

This was a multicenter, open-label, Phase II study in subjects with Human epidermal growth factor receptor (HER2)-positive metastatic breast cancer who received at least 2 prior lines of anti-HER2-targeted therapies of which at least one included a Trastuzumab-containing regimen. This study was a post-approval commitment with regulatory authorities. It was designed to evaluate whether treatment with Dual blockade promoted changes to biomarkers associated with immunomodulation.

NCT ID: NCT02187367 Terminated - Clinical trials for Carcinoma, Non-Small-Cell Lung

Safety & Efficacy Study of EGF Cancer Vaccine to Treat Stage IV Biomarker Positive, Wild Type EGF-R NSCLC Patients

EGF
Start date: May 2015
Phase: Phase 3
Study type: Interventional

The vaccine contains humanized recombinant antigen (EGF - Epithelial Growth Factor) and an adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation of tumour cell. A Phase 3 clinical trial on the EGF vaccine is ongoing in Cuba. The result from previous studies demonstrated positive correlation between extended survival and immune response against the vaccination in the late-stage NSCLC patients' age below 60 with improved quality of life. The purpose of this international Phase 3 trial is to determine whether the recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment of stage IV NSCLC patients who are positive in the selective EGF biomarker and wild type EGF-Receptor compared to standard treatment and supportive care.

NCT ID: NCT02158936 Terminated - Thrombocytopaenia Clinical Trials

A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

Start date: June 10, 2014
Phase: Phase 3
Study type: Interventional

Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350 subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75 Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care effects of eltrombopag versus placebo in combination with the standard of care hypomethylating agent, azacitidine. The primary objective of this study is to determine the effect of eltrombopag versus placebo on the proportion of subjects who are platelet transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints include overall survival, disease response, and disease progression.

NCT ID: NCT02150967 Terminated - Clinical trials for Advanced Cholangiocarcinoma

A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma

Start date: July 23, 2014
Phase: Phase 2
Study type: Interventional

This is a multi-center, open label, single arm phase II study evaluating BGJ398 (infigratinib) anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with fibroblast growth factor receptor (FGFR) genetic alterations.

NCT ID: NCT02131818 Terminated - Clinical trials for Perineal Wound Infection

Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term

Start date: May 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine amoxicillin is effective in the prevention of wound infection in normal labor.

NCT ID: NCT02117479 Terminated - Pancreatic Cancer Clinical Trials

Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

Start date: March 2014
Phase: Phase 3
Study type: Interventional

Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.

NCT ID: NCT02060487 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Effects of Oral Sildenafil on Mortality in Adults With PAH

AFFILIATE
Start date: September 22, 2014
Phase: Phase 4
Study type: Interventional

This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute walking distance (6MWD) will be assessed.

NCT ID: NCT02007720 Terminated - Acute Heart Failure Clinical Trials

Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF

RELAX-AHF-ASIA
Start date: March 12, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.

NCT ID: NCT02003794 Terminated - Ischemic Stroke Clinical Trials

Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)

IVIS
Start date: May 2013
Phase: Phase 3
Study type: Interventional

To study the result of intravenous fluid in patients with acute ischemic stroke within 72 hours.

NCT ID: NCT01975389 Terminated - Clinical trials for Cardiovascular Disease

The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects

SPIRE-2
Start date: October 29, 2013
Phase: Phase 3
Study type: Interventional

This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL (3.4 mmol/L).