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NCT ID: NCT01026142 Completed - Breast Cancer Clinical Trials

A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)

Start date: January 26, 2010
Phase: Phase 3
Study type: Interventional

This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity.

NCT ID: NCT01024491 Completed - Clinical trials for Premature Ejaculation

Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation

Start date: August 2008
Phase: Phase 3
Study type: Interventional

As study to investigate the efficacy and safety of daily doses of paroxetine of 15 and 20 mg for the treatment of premature ejaculation

NCT ID: NCT01024192 Completed - Sleep Disorders Clinical Trials

Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA

Start date: November 2009
Phase: Phase 4
Study type: Interventional

Primary Objective: To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic insomnia at the prescription conditions of daily practice Secondary Objective: To evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as needed basis.

NCT ID: NCT01023828 Completed - Clinical trials for Non-Small Cell Lung Cancer

K-RAS Oncogene Mutation in Patients With Advanced Non-Small Cell Lung Cancer Associated With Exposure to Wood Smoke and Tobacco Smoking: Therapeutic Implications

007/055/OMI
Start date: April 2005
Phase: N/A
Study type: Observational

Summary: Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death in the world. This neoplasia has a poor survival prognosis due to the low effectiveness of existing treatments. The low effectiveness is associated with the development of an intrinsic and acquired resistance of tumors, which clinically shows through early progression and transitory responses. Tobacco smoking is the major risk factor for NSCLC; however, wood smoke has been described as a strong carcinogen and a relevant risk factor for the development of NSCLC. Current data indicates that lung tumors associated with tobacco smoking and wood smoke show different clinical characteristics, which suggests that they might also have different genetic alterations, which are a consequence of tumor etiology. The description of the frequency and the type of mutations associated with different etiologies of NSCLC could represent the starting point for benefiting each patient according to their specific characteristics. One of the most researched signaling pathways related to cancer cell proliferation is the one activated by the K-RAS oncogene. Active K-RAS mutations have been detected in different types of neoplasia and more than 90% of these mutations occur at codon 12 of the oncogene. These mutations seem to be an independent risk factor for the prognosis of malignant tumors and they are associated with the lack of response to erlotinib, which is a tyrosine-kinase inhibitor. The investigators' research team has recently reported that wood smoke is an independent factor for survival and response to the erlotinib treatment, which suggests that this carcinogen could have a different frequency and pattern of mutations in the K-RAS oncogene, compared to what has been reported in smoking patients. Determining the tumor mutations within the K-RAS oncogene can help improve the response prognosis of patients with advanced NSCLC who have a background of exposure to different factors associated with the appearance of this neoplasia, such as wood smoke exposure or tobacco smoking. Therefore, the objective of this research is to determine the frequency and the type of mutations at codon 12 of the K-RAS oncogene in patients with NSCLC who have a background of exposure to tobacco smoking or wood smoke.

NCT ID: NCT01023581 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes

AM7D
Start date: November 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.

NCT ID: NCT01023308 Completed - Multiple Myeloma Clinical Trials

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

PANORAMA-1
Start date: December 21, 2009
Phase: Phase 3
Study type: Interventional

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile. Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.

NCT ID: NCT01023009 Terminated - Vitrectomy Clinical Trials

Postoperative Evolution After Small Gauge Vitrectomy Without Eye Occlusion

Vitrectomy
Start date: May 2009
Phase:
Study type: Observational

After an uneventfully small gauge vitrectomy we don´t think is necessary to occlude the eye for 24 hours

NCT ID: NCT01022164 Terminated - Surgery Clinical Trials

Use of Fibrin Glue in Vitreoretinalsurgery

fibringlue
Start date: May 2009
Phase: Phase 4
Study type: Interventional

To study the Safety and Efficacy of the use of fibrin glue in vitreoretinal surgery

NCT ID: NCT01021943 Suspended - Kidney Transplant Clinical Trials

Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The main objective of this study is to assess the effect of spironolactone on interstitial fibrosis in kidney transplant recipients receiving calcineurin inhibitors

NCT ID: NCT01020500 Completed - Muscle Spasticity Clinical Trials

To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke

ULIS2
Start date: January 2010
Phase:
Study type: Observational

The purpose of the study is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in accordance with routine practices.