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NCT ID: NCT01641939 Terminated - Gastric Cancer Clinical Trials

A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer

Start date: September 3, 2012
Phase: Phase 2/Phase 3
Study type: Interventional

This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks. Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal.

NCT ID: NCT01640951 Completed - Clinical trials for Moderate to Severe Chronic Plaque-Type Psoriasis

4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Start date: September 16, 2012
Phase: Phase 3
Study type: Interventional

CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.

NCT ID: NCT01638923 Completed - Metrorrhagia Clinical Trials

Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding

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

To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding

NCT ID: NCT01638520 Active, not recruiting - Clinical trials for Tuberculosis, Pulmonary

Safety and Efficacy of Blocking IL-4 With Pascolizumab in Patients Receiving Standard Therapy for Pulmonary Tuberculosis

Start date: June 2012
Phase: Phase 2
Study type: Interventional

New approaches are needed to achieve more rapid elimination of dormant mycobacteria and thereby shorten treatment for drug-sensitive and drug-resistant tuberculosis (TB). Dormant mycobacteria are relatively resistant to antibacterial drugs and approaches that enhance immune clearance have the potential to be more effective. Interleukin-4 (IL-4) is a key cytokine in the immune response to TB that may impair the clearance of mycobacteria. We hypothesize that pascolizumab, an anti-IL-4 monoclonal antibody, might be of value as an adjunct to standard treatment. The aims of this trial are to determine whether administration of pascolizumab as an adjunct to standard combination treatment for drug-sensitive TB produces changes in one or more parameters of bacterial or host response (including bacterial clearance, host clinical status, immune response, bacterial and host transcriptomics, lung imaging) that may indicate potential for enhanced sterilization and to confirm the safety of blocking IL-4 (previously demonstrated in healthy volunteers and patients with asthma) in patients with TB.

NCT ID: NCT01638325 Completed - Clinical trials for Healthy Participants

A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants

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

BC106 is a molecule that when injected with insulin lispro may change the speed of absorption of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin lispro and any side effects that might be associated with it, blood levels of insulin lispro after injection under the skin and how BC106 insulin lispro affects blood sugar after injection under the skin. There is a minimum 7 day washout between single doses.

NCT ID: NCT01636076 Completed - COPD Clinical Trials

Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Start date: November 2012
Phase: Phase 2
Study type: Interventional

To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with COPD

NCT ID: NCT01634165 Completed - Healthy Volunteers Clinical Trials

A Study of LY2963016 in Healthy Participants

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

This study involves 2 single injections of LY2963016 and 2 single injections of Lantus. There will be at least 6 days between each injection. The study will compare LY2963016 to Lantus at two different doses. This study is approximately 10 weeks long, not including screening. Screening is required within 4 weeks of the start of the study.

NCT ID: NCT01633398 Completed - Heart Failure Clinical Trials

ASIAN HF Registry, A Prospective Observational Study

ASIANHF
Start date: September 2012
Phase:
Study type: Observational

The ASIAN HF Registry is the first prospective multinational Asian registry of patients with symptomatic HF (stage C) including both HFrEF (ejection fraction <40%) and HFpEF (ejection fraction ≥50%), with the broad purpose of determining the mortality (incidence) burden of HF in Asian patients, and more specifically to define the burden and risk factors of Sudden Cardiac Deaths (SCD), as well as the sociocultural barriers to preventive device therapy. The study further aim to study the genetic variants associated with HFrEF versus HFpEF in our large Asian cohort. This proposed registry is expected to advance fundamental understanding of the burden and predictors of preventable death among Asian patients with HF. The knowledge gained will be critical for guiding resource allocation and planning preventive strategies to address the unmet and growing clinical needs of patients with cardiovascular disease in Asia.

NCT ID: NCT01633281 Terminated - Clinical trials for Peripheral Neuropathy Grade 2 or Greater

Acupuncture for Peripheral Neuropathy

Start date: June 2012
Phase: Phase 2
Study type: Interventional

A significant proportion (up to 60%) of myeloma patients treated with Bortezomib or thalidomide or both develop significant peripheral neuropathy (PN). Standard of care for this complication include drugs like gabapentin or pregabalin, which relieve symptoms only partially. PN of grade II or above mandates reduction in dose or frequency of Bortezomib or thalidomide, which may compromise treatment outcome. This clinical study explores whether, by intervening early in its course using acupuncture, progression of PN can be reversed, stabilized or retarded thereby allowing continuation of treatment on schedule.

NCT ID: NCT01630733 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Multinational, Randomized, Open-Label Study of Custirsen In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer

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

The primary objective of the study is to compare overall survival of patients randomized to receiving custirsen in combination with docetaxel (Arm A) with patients randomized to receive docetaxel alone (Arm B).