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NCT ID: NCT01909453 Active, not recruiting - Melanoma Clinical Trials

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma

COLUMBUS
Start date: September 16, 2013
Phase: Phase 3
Study type: Interventional

This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized. Part 1: Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms: 1. LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or 3. vemurafenib 960 mg BID (denoted as vemurafenib arm) Part 2: Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms: 1. LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm)

NCT ID: NCT01897480 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations

Balise
Start date: August 28, 2013
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.

NCT ID: NCT01896479 Active, not recruiting - Clinical trials for Medullary Thyroid Cancer

A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer

EXAMINER
Start date: December 2014
Phase: Phase 4
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a 60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will test if the lower dose results in similar progression free survival (PFS) and overall response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events found in previous clinical trials of 140 mg.

NCT ID: NCT01894256 Active, not recruiting - Solid Tumours Clinical Trials

Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal or Impaired Kidney Function

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

This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate renal impairment compared to patients with normal renal function; Part B will allow eligible study patients continued access to olaparib after the PK phase and will provide additional safety data.

NCT ID: NCT01887938 Active, not recruiting - Clinical trials for Metachromatic Leukodystrophy (MLD)

An Efficacy and Safety Study of HGT-1110 in Participants With Metachromatic Leukodystrophy

Start date: May 23, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to collect long-term safety data in participants with metachromatic leukodystrophy (MLD) who are receiving HGT-1110 and have participated in Study HGT-MLD-070 (NCT01510028) through Week 40.

NCT ID: NCT01884779 Active, not recruiting - HIV Clinical Trials

Prevalence of Histoplasmosis in HIV + Patients With a Rapid Diagnostic Test in West Indies

EDIRAPHIS
Start date: August 2013
Phase: N/A
Study type: Observational [Patient Registry]

Histoplasma capsulatum var. capsulatum histoplasmosis is the leading cause of acquired immunodeficiency syndrome (AIDS) and death in French Guiana and probably in the Amazon. The diagnosis of this disease requires invasives procedures, laboratory performance, and delays up to several weeks. The Mycotic Diseases Branch of the Centers for Disease Control and Prevention (CDC) has established a rapid, sensitive and specific ELISA test for blood and urine samples that looks interesting in endemic areas, particularly in developing countries. The study aims to measure the proportion of HIV-infected patients hospitalized or in outpatient awaiting hospitalization for a suspicion of infectious syndrome whose serum and/or urinary antigen detection tests are positive for Histoplasma capsulatum var. capsulatum.

NCT ID: NCT01882933 Active, not recruiting - Clinical trials for Gastric Adenocarcinoma

D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma

GASTRICHIP
Start date: June 2013
Phase: Phase 3
Study type: Interventional

A prospective, opened, multicentric, randomised, phase III trial with two arms: - Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin - Arm B: curative gastrectomy with D1-D2 lymph node dissection Main objective: Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone.

NCT ID: NCT01880359 Active, not recruiting - Clinical trials for Locally Advanced Head and Neck HPV Negative Squamous Cell Cancers

AF CRT +/- Nimorazole in HNSCC

Start date: July 25, 2014
Phase: Phase 3
Study type: Interventional

The drug nimorazole belongs to a class of chemicals known as 5-nitroimidazoles. Drugs from this class are used against infection. In addition, nimorazole makes tumor cells more sensitive to radiotherapy. Therefore, the investigators want to find out whether the addition of nimorazole to the standard treatment with radiotherapy in combination with chemotherapy with cisplatin shows activity against your type of head and neck cancer and is safe. Furthermore the investigators will investigate if a specific examination done with your tumor tissue will help to predict whether the treatment will work or not. To find out if the activity observed with this treatment is not caused by chance alone, the investigators need to obtain data from patients who receive this treatment and from patients who receive other treatments. The data from these two groups of patients will be compared to see which treatment is better. Participants will be split into 2 groups. Each group will receive different treatments. The treatment each group receives is determined by chance using a computer program. This works like flipping a coin and is called randomization. This helps to make sure that groups of patients are similar when the study starts. Neither you, your study doctor, nor the study staff can influence in which group you will be placed or which treatment you will receive. If allocated to group 1, Patient will receive radiotherapy in combination with chemotherapy with cisplatin and nimorazole as a pill. This is considered the 'experimental' treatment. If allocated to group 2, patient will receive radiotherapy in combination with chemotherapy with cisplatin and a so called 'placebo' as a pill. The placebo is a dummy treatment. It looks like the real one, but it is not. It contains no active ingredient/medicine.

NCT ID: NCT01874353 Active, not recruiting - Clinical trials for Relapsed Ovarian Cancer

Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

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

A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.

NCT ID: NCT01872728 Active, not recruiting - Clinical trials for Outpatient Rhinoplasty

Facial Block for Outpatient Rhinoplasty Analgesia

FABLORA
Start date: June 2013
Phase: Phase 3
Study type: Interventional

A bilateral facial block (infraorbital and infratrochlear) will be performed immediately after intubation in patients undergoing outpatient rhinoplasty with 2.5% levobupivacaine (intervention group) or saline as control. Intravenous saline or morphine will be administered at the end of surgery in intervention or control groups, respectively. In case of pain in post-anesthesia care unit (numerical pain score >3 on a 0-10 scale), both groups will receive intravenous morphine titration. The total perioperative morphine consumption (intraoperative and in post-anesthesia care unit) will be compared between groups. Pain intensity, presence of nausea/vomiting and patient's satisfaction will be compared between groups.