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NCT ID: NCT01121575 Completed - Clinical trials for Non Small Cell Lung Cancer

A Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer

Start date: August 2010
Phase: Phase 1
Study type: Interventional

Lung cancer tumors become resistant to the first generation epidermal growth factor receptor (EGFR) inhibitors erlotinib or gefitinib by changing and increasing the activity of two cell signaling pathways: the cMET pathway and the EGFR pathway. Both resistance mechanisms can occur at the same time, in the same patient and even in the same tumor. This study combines a second generation EGFR inhibitor and a cMET inhibitor to block both these pathways in order to overcome resistance and treat this disease.

NCT ID: NCT01121042 Completed - Schizophrenia Clinical Trials

Double Blind, Placebo-Controlled, Randomised Investigation of Ondansetron in Schizophrenia

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the overall effectiveness of Ondansetron as an adjunctive or "add-on" medication in the treatment of Schizophrenia. This study is a double blind, placebo-controlled, randomised, 12 week trial.

NCT ID: NCT01120795 Completed - Chronic Hepatitis C Clinical Trials

Pegylated Interferon and Ribavirin in Hepatitis C Patients on Opioid Pharmacotherapy

Start date: February 2004
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see if treatment of chronic hepatitis C in people who are on opiate replacement therapy such as methadone or buprenorphine (including patient who still inject drugs) is safe and effective.

NCT ID: NCT01120535 Completed - Pulmonary Embolism Clinical Trials

Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4

RETRIEVE 4
Start date: May 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.

NCT ID: NCT01120184 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)

Start date: July 31, 2010
Phase: Phase 3
Study type: Interventional

This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.

NCT ID: NCT01119859 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis

Start date: May 2010
Phase: Phase 4
Study type: Interventional

This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.

NCT ID: NCT01117441 Completed - Leukemia Clinical Trials

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia

Start date: June 2010
Phase: Phase 3
Study type: Interventional

Rationale/Purpose: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia (ALL). This trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with ALL. Study objectives Primary study questions: - Non high-risk (non-HR) precursor-B ALL (pB-ALL) patients with TEL/AML1-negative ALL or unknown TEL/AML1 status and flow cytometry minimal residual disease (MRD) in bone marrow on day 15 <0.1% or with TEL/AML1-positive ALL (randomized study question R1): Can the daunorubicin dose in Protocol IA be safely reduced by 50 % with a non-inferior EFS and a reduction of toxicity (treatment-related mortality and AE/SAE in Protocol I)? - Patients with pB-ALL and risk group medium risk (MR) (randomized study question R2): Can the clinical outcome be improved by protracted asparagine depletion achieved through application of intensified PEG-L-asparaginase during reintensification and early maintenance? - High-risk (HR) patients (as identified by day 33 - randomized study question RHR): Can the clinical outcome be improved by protracted exposure to PEG-L-asparaginase during Protocol IB? Secondary study questions: - Standard risk (SR) patients identified by at least one sensitive marker: Is the clinical outcome comparable to that obtained in SR patients (identified with two sensitive markers) in AIEOP-BFM ALL 2000, or can the outcome even be improved with the use of PEG-L-asparaginase instead of native E. coli L-ASP? - T-ALL non-HR patients: Can the high level of outcome which was obtained for these patients in study AIEOP-BFM ALL 2000 be preserved or even improved with the use of PEG-L-ASP instead of native E. coli L-ASP? - HR patients with persisting high MRD levels despite the use of the HR blocks in the intensified consolidation phase "MRD Non-Responders": Is it possible to improve the outcome and to achieve a further reduction of leukemic cell burden by administration of an innovative treatment schedule (DNX-FLA)? - Patients participating in the randomized asparaginase studies (pB-ALL/MR, HR): Are asparaginase activity and asparaginase antibodies associated with development of allergic reactions, and do they have an effect on the outcome of the patients? - What is the relative value of different methods of MRD monitoring in the definition of alternative stratification systems within a BFM-oriented protocol?

NCT ID: NCT01117012 Completed - Cystic Fibrosis Clinical Trials

Rollover Study of VX-770 in Cystic Fibrosis Subjects

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF). The secondary objective of the study was to evaluate the efficacy of long-term VX-770 treatment in subjects with CF.

NCT ID: NCT01116206 Completed - Constipation Clinical Trials

An Efficacy and Safety Study of Prucalopride in Participants With Chronic Constipation

Resolor
Start date: May 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of prucalopride to placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in treatment of participants with chronic (very serious, life threatening) constipation (decreased number of or difficulty making bowel [the intestine] movements).

NCT ID: NCT01114529 Completed - Clinical trials for Renal Transplantation

Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients

ELEVATE
Start date: August 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to standard CNI treatment in de novo renal allograft recipients. In addition, the study is designed to evaluate the impact of a CNI-free regimen on evolution of cardiovascular parameters in de novo renal allograft recipients