Clinical Trials Logo

Filter by:
NCT ID: NCT01615796 Completed - Clinical trials for Infections, Respiratory Tract

Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Repeat IV Doses

Start date: June 4, 2012
Phase: Phase 1
Study type: Interventional

GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive pathogens including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens associated with respiratory tract, skin and soft tissue infections including isolates resistant to existing classes of antimicrobials.

NCT ID: NCT01614197 Completed - Clinical trials for Peripheral T-cell Lymphoma

A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

Start date: July 3, 2015
Phase: Phase 1
Study type: Interventional

This is a phase I study of temsirolimus (Torisel) combined with dexamethasone, cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL).

NCT ID: NCT01611805 Completed - Crohn's Disease Clinical Trials

Japanese Phase I of GSK1605786

Start date: July 22, 2010
Phase: Phase 1
Study type: Interventional

This is an double-blind, single dose, four-period, crossover study in Japanese healthy male volunteers to assess the pharmacokinetics and safety/tolerability of single doses of GSK1605786A. Approximately 24 subjects will receive three treatments of 250, 500, and 1000mg GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose ascending crossover design. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The pharmacokinetics and dose proportionality of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg, 500mg and 1000 mg under fasted conditions will be assessed. In addition, a comparison will be made between the pharmacokinetics of GSK1605786 under fed and fasted conditions.

NCT ID: NCT01610414 Completed - Herpes Zoster Clinical Trials

Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A

Start date: July 13, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.

NCT ID: NCT01610375 Completed - Endometrial Cancer Clinical Trials

Telephone Follow-up After Treatment for Endometrial Cancer

TEACUP
Start date: June 2012
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the feasibility, safety and accuracy of a telephone follow-up for women previously treatment for endometrial cancer. To achieve this aim, potentially eligible women attending the Queensland Centre for Gynaecological Cancer (QCGC) outpatient clinic for review following previous treatment for endometrial cancer will be recruited by this study. The study aims to recruit all new patients as well as all patients who return to QCGC for their follow-up and who had treatment within the previous 2 years. The proposed project will involve generation of an evidence-based checklist of signs and symptoms of disease recurrence from a thorough literature review. The generated symptom checklist will be pilot tested and the refined symptom checklist will be used to follow study participants over a period of 12 months. During the follow-up period, the basic standard of follow-up after primary treatment for endometrial cancer at the QCGC, Royal Brisbane and Women's Hospital (RBWH)will not be altered; however, the study participants will be interview via telephone 2 to 5 days prior to their scheduled review dates. The main outcome measure will be the estimated recurrence rate as derived from the telephone assessment and this will be compared to the clinically detected recurrences as recorded in patients' medical files. It is hypothesized, that the telephone follow-up will identify 90% of all recurrences correctly that are later confirmed during the clinical follow-up. In addition to the main outcome, we will also assess patients' satisfaction with each of the follow-up programs, whether or not lifestyle behaviours were queried and support offered to improve wellbeing.

NCT ID: NCT01610336 Completed - Clinical trials for Non-small Cell Lung Cancer

A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment

Start date: April 5, 2012
Phase: Phase 2
Study type: Interventional

This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib.

NCT ID: NCT01610284 Completed - Breast Cancer Clinical Trials

Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

BELLE-2
Start date: August 7, 2012
Phase: Phase 3
Study type: Interventional

This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.

NCT ID: NCT01610245 Completed - Influenza Clinical Trials

Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

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

This study is a global multicenter randomized factorial double-blind, placebo-controlled trial designed to evaluate (i) efficacy and safety of nitazoxanide 600 mg administered orally twice daily for five days compared to a placebo in the treatment of acute uncomplicated influenza and (ii) efficacy and safety of combination therapy with nitazoxanide 600 mg plus Oseltamivir 75 mg co-administered orally twice daily for five days compared to nitazoxanide monotherapy (600 mg b.i.d. for 5 days) and Oseltamivir monotherapy (75 mg b.i.d. for 5 days) in the treatment of acute uncomplicated influenza.

NCT ID: NCT01610102 Completed - Clinical trials for Long Term Safety of the AMS 1.0

PROGRESS-AMS 1.0 Clinical Long Term Follow-Up

Start date: July 2011
Phase: N/A
Study type: Observational

The primary objective of this study is to collect long term clinical follow-up data on all patients enrolled in the PROGRESS AMS-1.0 study to assess long term safety of the AMS-1.0

NCT ID: NCT01609296 Completed - Clinical trials for Peripheral Arterial Disease

IN.PACT Global Clinical Study

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

The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiralâ„¢ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.