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NCT ID: NCT00678535 Completed - Gastric Cancer Clinical Trials

Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer

EXPAND
Start date: June 2008
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS). Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.

NCT ID: NCT00678418 Completed - Opiate Dependence Clinical Trials

ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence

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

This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid dependence. The study was conducted in 2 parts, Part A and Part B. The clinical portion of both parts has completed. Results for Part B are not yet available.

NCT ID: NCT00678392 Completed - Kidney Neoplasms Clinical Trials

Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

Start date: September 3, 2008
Phase: Phase 3
Study type: Interventional

The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.

NCT ID: NCT00677053 Completed - Clinical trials for Acute Coronary Syndrome

Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes

Start date: March 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of multiple doses of TAK-442once daily, (QD) or twice daily (BID), in subjects with acute coronary syndrome (unstable angina, myocardial infarction).

NCT ID: NCT00676715 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

Start date: July 17, 2008
Phase: Phase 2
Study type: Interventional

This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

NCT ID: NCT00676663 Completed - Breast Cancer Clinical Trials

Study to Evaluate Exemestane With and Without Entinostat (SNDX-275) in Treatment of Postmenopausal Women With Advanced Breast Cancer

ENCORE301
Start date: June 13, 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with exemestane in the treatment of advanced breast cancer.

NCT ID: NCT00676338 Completed - Clinical trials for Type 2 Diabetes Mellitus

Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

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

This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.

NCT ID: NCT00675961 Completed - Tuberculosis Clinical Trials

Effectiveness of Alcohol Interventions Among Tuberculosis (TB) Patients in Tomsk Oblast, Russia

IMPACT
Start date: January 2007
Phase: N/A
Study type: Interventional

The primary goal of this study is to assess the effectiveness of two alcohol interventions administered singly or in combination as an integrated component of TB care provided to patients with co-occurring TB and AUDs in Tomsk, Russia. Here we propose two parts of this study: First, a pilot study to provide Naltrexone to TB patients will be conducted. If feasibility and safety are demonstrated, then we will conduct a randomized clinical trial (RCT) of the following four study arms: 1. A Behavioral Counseling Intervention (BCI) plus treatment as usual (TAU) (i.e. standard referral to and management by an addictions specialist); 2. Naltrexone/ Brief Behavioral Compliance Enhancement Treatment (BBCET) plus TAU 3. BCI + Naltrexone/BBCET plus TAU 4. TAU The RCT will be conducted only if Naltrexone use proves safe and feasible in the pilot study. However, because the pilot does not have a control group and nor is it a Phase I clinical trial, we define "safety" here as demonstration of appropriate adverse event management and adequate safety monitoring procedures, all of which will also be used in the RCT. The specific aims of the pilot are: 1. To determine the feasibility of administering Naltrexone to patients receiving TB treatment, and 2. To assess the safety of administering Naltrexone to patients receiving TB treatment. The investigators aim to test the following hypotheses for the pilot: co-administration of Naltrexone with TB treatment is feasible and safe in a population of TB patients with AUDs. The specific aims of the RCT are: 1. To compare TB treatment outcomes among patients in each of the three intervention arms with the control arm of treatment as usual, and 2. To compare the change in mean number of heavy drinking days in last month of study period compared with baseline among patients in each of the three intervention arms with the control arm of treatment as usual. The investigators aim to test the following hypotheses for the RCT: Individuals receiving one of the three interventions (Naltrexone, BCI or the combination of Naltrexone/BCI) will experience better TB outcomes and a greater change in the mean number of heavy drinking days, compared with individuals receiving treatment as usual.

NCT ID: NCT00674973 Completed - Pancreatic Cancer Clinical Trials

A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer

Start date: June 2008
Phase: Phase 2
Study type: Interventional

This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

NCT ID: NCT00674635 Completed - Clinical trials for Arthritis, Rheumatoid

Phase II Study Evaluating the Safety and Efficacy of GSK315234A in Patients With Rheumatoid Arthritis

Start date: April 2008
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blinded, placebo-controlled adaptive, dose finding study to investigate the safety, tolerability, PK, PD and efficacy of single and repeat intravenous infusions of GSK315243A in patients with active rheumatoid arthritis. The study is divided into 2 parts: Part A is an adaptive, dose finding phase which will provide safety, tolerability, PK and PD on single intravenous infusions. Part B is a repeat dose phase which will provide safety, tolerability, PK, PD and efficacy following repeat intravenous infusions of a selected dose level.