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NCT ID: NCT01774786 Completed - Gastric Cancer Clinical Trials

A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

JACOB
Start date: June 10, 2013
Phase: Phase 3
Study type: Interventional

This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram [mg/kg] intravenously [IV] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.

NCT ID: NCT01774721 Completed - Clinical trials for Non-small Cell Lung Cancer With EGFR-Activating Mutations

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

Start date: May 9, 2013
Phase: Phase 3
Study type: Interventional

This is a multinational, multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of treatment with dacomitinib (PF-00299804) to treatment with gefitinib in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal growth factor receptor EGFR-activating mutation (s). Analyses of primary objective (Progression Free Survival) will be done as defined in the protocol.

NCT ID: NCT01774474 Completed - Diabetes Mellitus Clinical Trials

PRevention of Macular EDema After Cataract Surgery

PREMED
Start date: July 10, 2013
Phase: Phase 3
Study type: Interventional

Cystoid macular edema (CME) is a common cause of vision loss after cataract surgery. In the last few years, several new treatments have been tried to address the problem of CME after cataract surgery in diabetic and non-diabetic patients. The investigators will perform a large RCT with the aim to provide more definite evidence-based recommendations for clinical guidelines to prevent the occurrence of CME after cataract surgery in patients with and without diabetes mellitus (DM).

NCT ID: NCT01774344 Completed - Clinical trials for Carcinoma, Hepatocellular

Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma

RESORCE
Start date: May 14, 2013
Phase: Phase 3
Study type: Interventional

The objective of this study was to evaluate efficacy and safety of regorafenib in patients with advanced liver cancer who had progressed after sorafenib treatment. Patients were treated with regorafenib or placebo using a 2:1 randomization scheme.

NCT ID: NCT01772797 Completed - Clinical trials for Non-small Cell Lung Cancer

Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer

Start date: June 2013
Phase: Phase 1
Study type: Interventional

The primary purpose of the study is to estimate the maximum tolerated dose of the combination of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in ALK-rearranged non-small cell lung cancer.

NCT ID: NCT01772576 Completed - Tachycardia Clinical Trials

Safety and Performance Study of the Reliance 4-Front Lead

Start date: October 2012
Phase: N/A
Study type: Interventional

The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONTâ„¢ Active Fixation Defibrillation Leads.

NCT ID: NCT01772446 Completed - Diabetes Clinical Trials

Effectiveness of SMS in Diabetes Control

SMSaludD
Start date: June 2013
Phase: N/A
Study type: Interventional

Introduction: The Spanish Society of Family and Community Medicine, started the Program of Preventive Activities and Health Promotion, which generates periodic recommendations of preventive methods based on scientific evidence. In the last update it has become evident the need of modifications to adapt the program to modern times and focuses on improving accessibility and offering more flexible responses to users of the program. In this sense, the mobile phone technology could be useful, specifically the messaging service to remind patients their appointments and increase attendance rates. Main objective Compare the percentage of patients in the intervention group compared with the control group who achieved a figure of HbA1c <7% in 2013.Design: single blind Randomized Clinical Trial. Study population: Patients with diabetes with or without hypertension or lipid metabolism disorder, over 18 years, belonging to the Public Health System of Basque Country (primary care) meeting the inclusion / exclusion criteria. Sample size: 238 patients (119 per arm) to detect a difference of 16% in the percentage of patients with HbA1c lower than 7% between groups: Short Messages Standard (SMS) group: Mobile messages reminding the next review of Papps. Control group: Routine clinical practice. Statistical analysis: The relationship between the intervention received and the main variable (compliance with preventive activities at 12 months) were analyzed using a logistic regression model.

NCT ID: NCT01772316 Completed - Clinical trials for Rheumatoid Arthritis

A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

Start date: December 2012
Phase: Phase 3
Study type: Interventional

This multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have completed the 97-week WA22762 or the 96-week NA25220 core study. Patients will receive RoActemra/Actemra 162 mg subcutaneously weekly (for patients entering from WA22762) or every two weeks (for patients entering from NA25220) for 96 weeks, with telephone call follow-up visits at Weeks 100 and 104.

NCT ID: NCT01772199 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis

Start date: February 2013
Phase: Phase 2
Study type: Interventional

This is a randomized, parallel group, placebo-controlled study designed to assess whether GSK239512 can enhance lesion remyelination in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). Subjects with RRMS on stable background treatment with either Avonex (Interferon-beta1a) or Copaxone (Glatiramer Acetate) are eligible to participate. Subjects will be randomized in a 1:1 ratio between placebo and GSK239512, and will continue to be managed with their current standard of care therapy (Copaxone or Avonex). The total treatment period is 48 weeks, including a standard 4 week titration period and 44 week maintenance treatment period (which could be adapted to a 5-week titration and 43 week maintenance period, if needed). Titration doses start at 10 micrograms (mcg) and increase up to 80 mcg (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week). Subjects will be titrated to the maximum tolerated dose with the objective of titrating to the highest dose (80 mcg GSK239512), whenever possible, based on investigator judgement of tolerability. The post-treatment follow-up period will be a minimum of 2 weeks in duration following the end of treatment at Week 48 or early withdrawal, as appropriate.

NCT ID: NCT01771848 Completed - Malaria Clinical Trials

Optimization of Controlled Human Malarial Infection by Injection of P. Falciparum Sporozoites in Non-Immune Adults

Start date: December 2012
Phase: Phase 1
Study type: Interventional

The study is designed to establish the best dose to safely infect healthy individuals with Plasmodium falciparum sporozoites (PfSPZ) by injection. The goal of this study is to achieve infections in human volunteers with infection rates of 100% and pre-patent periods of less than 12 days.