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NCT ID: NCT01915602 Completed - Clinical trials for Carcinoma, Hepatocellular

Refametinib in Combination With Sorafenib in RAS Mutant Hepatocellular Carcinoma (HCC)

Start date: September 27, 2013
Phase: Phase 2
Study type: Interventional

This is a study to investigate the potential clinical benefit of refametinib when given in combination with sorafenib as first line treatment in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least partial response according to an objective criteria to evaluate tumor size based on contrast enhancement [modified response evaluation criteria in solid tumors (mRECIST)] assessed by external independent radiologists. Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib in combination with sorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib in combination with sorafenib improves the response rate in this patient population compared to historical results observed with the sorafenib only.

NCT ID: NCT01915589 Completed - Clinical trials for Carcinoma, Hepatocellular

Refametinib(BAY86-9766) in RAS Mutant Hepatocellular Carcinoma (HCC)

Start date: September 16, 2013
Phase: Phase 2
Study type: Interventional

This is a study to investigate the potential clinical benefit of refametinib in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least confirmed partial response (PR) according to modified response evaluation criteria in solid tumors (mRECIST) assessed by central image review. Refametinib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib improves the response rate in this RAS mutation patient population.

NCT ID: NCT01914757 Completed - Asthma Clinical Trials

Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist

Start date: August 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.

NCT ID: NCT01914666 Completed - Clinical trials for Back Pain Lower Back Chronic

An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain

Start date: September 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the long term safety of duloxetine in participants with Chronic Low Back Pain (CLBP).

NCT ID: NCT01913028 Completed - Healthy Clinical Trials

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI9929 After Single Administration in Healthy Male Japanese Subjects

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

The purpose of this study is to assess safety, tolerability, pharmacokinetics and immunogenicity of MEDI9929 following administration of single ascending doses in healthy male Japanese subjects.

NCT ID: NCT01911936 Completed - Neoplasms Clinical Trials

A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors

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

This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.

NCT ID: NCT01911780 Completed - Hypertension Clinical Trials

Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine

Start date: July 2013
Phase: Phase 3
Study type: Interventional

This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg + hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/H12.5 mg. In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide 12.5 mg will be evaluated in a 52-week extension period. In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5 mg group change to the T80/A5/H12.5 mg therapy.

NCT ID: NCT01911754 Completed - Influenza Clinical Trials

Japanese Pediatric H5N1 Vaccine Study

Start date: August 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic influenza vaccine in a Japanese pediatric population aged 6 months to 17 years

NCT ID: NCT01910636 Completed - Hepatitis C Clinical Trials

Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection

Start date: February 2013
Phase: Phase 3
Study type: Interventional

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.

NCT ID: NCT01910064 Completed - Acne Vulgaris Clinical Trials

A Long Term Study of GK530G in Subjects With Acne Vulgaris

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

This open label study is to determine the safety profile of GK530G in a long-term treatment (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a long-term treatment.