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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Statistical Software for Data Analysis and Clinical Trials01:12

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Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
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Trial and Error and Algorithm

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A problem-solving strategy is a plan of action used to find a solution. Different strategies have distinct action plans. Trial and error involves trying different solutions until one works. For instance, to fix a broken printer, you might check ink levels, ensure the paper tray isn't jammed, and verify the printer's connection to your laptop. This method can be time-consuming but is commonly used. Thomas Edison, for example, used trial and error to find a suitable filament for the light...
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Aneurysm II: Clinical Manifestations and Diagnostic Studies01:21

Aneurysm II: Clinical Manifestations and Diagnostic Studies

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Thoracic, aortic arch and abdominal aneurysms are significant vascular conditions that can present with various clinical manifestations and lead to serious complications. Understanding these manifestations and the appropriate diagnostic studies is essential for effective management and treatment.Thoracic Aortic AneurysmsThoracic aortic aneurysms often remain asymptomatic until they reach a size that impinges on adjacent structures. They typically cause deep, diffuse chest pain that radiates to...
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Hypertension III: Clinical Manifestations and Diagnostic Studies01:30

Hypertension III: Clinical Manifestations and Diagnostic Studies

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Hypertension is asymptomatic and also referred to as the "silent killer" until it progresses to a severe stage or causes target organ disease. Patients may experience symptoms stemming from the strain on blood vessels and tissues in various organs or the heart's increased workload.Physical exams might show no abnormalities other than high blood pressure. Signs of vascular damage, when present, correspond to the organs supplied by the affected vessels, leading to target organ damage. For...
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In Silico Clinical Trials for Cardiovascular Disease
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A clinical trial protocol paper discussing the BRIGHTER study.

Mohamad Bassam Sonbol1, Tanios Bekaii-Saab1

  • 1Mayo Clinic Cancer Center, Mayo Clinic, Phoenix, AZ 85054, USA.

Future Oncology (London, England)
|January 4, 2018
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The BRIGHTER trial investigated napabucasin plus paclitaxel for advanced gastric cancer. This combination therapy did not improve overall survival in patients previously treated for this malignancy.

Keywords:
BBI608gastric cancernapabucasin

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Area of Science:

  • Oncology
  • Gastroenterology
  • Clinical Trials

Background:

  • Napabucasin, a novel oral cancer stemness inhibitor, demonstrated promising preclinical and early clinical antitumor activity.
  • Advanced gastric and gastroesophageal junction adenocarcinoma has limited treatment options for previously treated patients.

Purpose of the Study:

  • To evaluate the efficacy and safety of combining napabucasin with paclitaxel in patients with advanced gastric and gastroesophageal junction adenocarcinoma.
  • To assess overall survival as the primary endpoint in a Phase III clinical trial.

Main Methods:

  • A multicenter, randomized, placebo-controlled, Phase III study (BRIGHTER trial).
  • Patients received weekly paclitaxel with either napabucasin or placebo in a 1:1 randomization.
  • The study included patients with previously treated advanced gastric and gastroesophageal junction adenocarcinoma.

Main Results:

  • The study failed to meet its primary endpoint of improving overall survival in the intention-to-treat population.
  • Ongoing analysis is evaluating secondary endpoints, including progression-free survival and objective response rate.
  • Safety of the combination therapy is also being assessed.

Conclusions:

  • Combining napabucasin with paclitaxel did not significantly improve overall survival in previously treated patients with advanced gastric and gastroesophageal junction adenocarcinoma.
  • Further analysis of secondary endpoints and biomarker-positive subpopulations may provide additional insights.