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NCT ID: NCT01685138 Completed - Clinical trials for Non-Small Cell Lung Cancer

LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer

Start date: December 20, 2012
Phase: Phase 2
Study type: Interventional

A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anticancer therapy and/or died. LDK378 was continued beyond RECIST defined progressive disease (PD) as assessed by the investigator, if in the judgment of the investigator, there was evidence of clinical benefit. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator. Male and female patients aged 18 or over with ALK-rearranged non-small cell cancer (NSCLC) were screened for eligibility. Patients had to have received no prior crizotinib, and had to be chemotherapy-naïve or been pretreated with cytotoxic chemotherapy (up to three prior lines).

NCT ID: NCT01685060 Completed - Clinical trials for Non-Small Cell Lung Cancer

LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib

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

A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd will continue until the patient experiences unacceptable toxicity that precludes further treatment, discontinues treatment at the discretion of the investigator or patient, starts a new anti-cancer therapy and/or dies. LDK378 may be continued beyond RECIST-defined PD as assessed by the investigator if, in the judgment of the investigator, there is evidence of clinical benefit. In these patients tumor assessment should continue as per the schedule of assessments until treatment with LDK378 is permanently discontinued. Patients who discontinue the study medication in the absence of progression will continue to be followed for tumor assessment until the time of PD as assessed by the investigator

NCT ID: NCT01685008 Completed - Clinical trials for Non-Hodgkin Lymphoma

Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat Non-Hodgkin's Lymphoma (NHL)

Start date: April 23, 2013
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter study to characterize the safety and efficacy of the human anti-CD19 antibody MOR00208 in adult patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) who have received at least 1 prior therapy containing rituximab (at least once).

NCT ID: NCT01684878 Completed - Ovarian Cancer Clinical Trials

Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)

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

This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).

NCT ID: NCT01684813 Completed - Clinical trials for Acute Coronary Syndrome

VERifynow in DIabetes Non-responsiveness: a Study on Switching From Clopidogrel to Prasugrel

VERDI
Start date: October 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if, in type 2 diabetic patients undergoing treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of 75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.

NCT ID: NCT01684787 Completed - Chronic Hepatitis C Clinical Trials

Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients

CONTRA
Start date: September 2006
Phase: Phase 4
Study type: Interventional

In the current practice patients with normal levels of ALT were not treated. However, a percentage of patients will present an advanced grade of fibrosis and cirrhosis. Another reason to treat is the similar response to the treatment than elevated ALT patients published recently in mono-infected patients. The investigators have not data concerning the evolution and response to the treatment in co-infected patients with normal ALT. In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it assumes a behavior similar between mono and co-infected patients and the results are different. In the case of normal ALT the investigators do not know if the natural history in co-infected patients is similar than the mono-infected patients, and also the response of the treatment. This study prospective and controls is the answer of this question. The main hypothesis is if the response of treatment in co-infected patients is not inferior than mono-infected patients. The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning genotype, gender and hospital.

NCT ID: NCT01684449 Completed - Clinical trials for Advanced Soft Tissue Sarcoma

Gemcitabine Plus Rapamycin Versus Gemcitabine to Treat Advanced Soft Tissue Sarcoma

Start date: January 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The soft tissue sarcomas (STS) constitute an infrequent group of malignant neoplasms of mesenchymal origin. In Spain, the approximate incidence is of 2 new cases per 100.000 inhabitants every year. In patients with metastatic STS, the average survival is very short, approximately 12 months. The systemic treatment of the metastatic disease has had a very limited development, with few satisfactory results. This facts reflect the urgent need to identify new active agents for treatment of these patients. The molecular pathway of the serine/threonine kinase mammalian target of rapamycin (mTOR) plays a central role in the regulation of the proteins translation, cellular growth and metabolism (Meric-Bernstam F et al. 2009). Currently, the mTOR pathway is considered a relevant target for the development of anti-cancer drugs, as rapamycin. Preliminary results of some clinical trials suggest that mTOR inhibitors could have some clinical activity for different types of sarcoma, including STS (Chawla et al Proc.ASCO 2006; Schuetze et al. Proc.ASCO 2006). Gemcitabine is a chemotherapy antimetabolite agent with a broad antitumoral spectrum. The activity of this drug to treat resistant sarcomas and its reduced toxicity make from gemcitabine an adequate candidate for its study in combination with new drugs addressed to molecular targets in the STS treatment. Pre-clinical studies suggest that mTOR inhibitors could have a potential synergistic or additive effect with some chemotherapy agents. The combination of rapamycin and gemcitabine seems to be a reasonable strategy to explore for the STS treatment.

NCT ID: NCT01684332 Completed - Clinical trials for Hyperglycemia, Postprandial

Postprandial Response to Different Jams

Start date: September 2010
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effects of an acute intake of three different types of strawberry jam, differing in the carbohydrates and antioxidants content, on postprandial glucose metabolism, lipid profile, antioxidant status and satiety indices, in healthy adults.

NCT ID: NCT01682863 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB in Patients With COPD Who Have Moderate to Severe Airflow Limitation

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

This study is to assess the safety and tolerability of two different dose levels of QVA149

NCT ID: NCT01682720 Completed - Hepatitis C Clinical Trials

Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

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

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.