MedPath

Clinical Trial News

Ivy Brain Tumor Center Launches Clinical Trial for Brain Cancer Treatment

  • The Ivy Brain Tumor Center in Phoenix is conducting a clinical trial to evaluate a new drug for treating brain cancer patients.
  • The trial marks a significant step in exploring innovative therapies for extending the lives of individuals diagnosed with brain tumors.
  • The first patient in the clinical trial is from Arizona, highlighting the center's commitment to local healthcare advancements.

Inari Medical's PEERLESS Trial Data to be Unveiled at TCT 2024

  • Inari Medical's PEERLESS trial data, comparing FlowTriever with catheter-directed thrombolysis for intermediate-risk pulmonary embolism, will be presented at TCT 2024.
  • The PEERLESS trial is a prospective, randomized controlled trial evaluating clinical and hospital resource utilization outcomes using a win-ratio analysis.
  • This trial is the first RCT directly comparing FlowTriever to a historical treatment for pulmonary embolism, providing crucial information for optimal treatment strategies.
  • The presentation at TCT 2024 will feature Dr. Wissam Jaber discussing the trial's findings and their implications for treating PE patients.

Canadian Institutes of Health Research Funds Four New Clinical Trials at RI-MUHC

  • The Canadian government invests over $43 million in 14 new clinical trials to address health emergencies and strengthen the life sciences sector.
  • Researchers at the Research Institute of the McGill University Health Centre (RI-MUHC) will lead four of these newly funded trials.
  • The trials cover diverse areas, including post-sepsis treatment, tuberculosis prevention, COVID-19 vaccine co-administration in immunocompromised hosts, and antibiotic treatment decisions in ICUs.
  • These trials are supported by the Canadian Institutes of Health Research (CIHR) Clinical Trials Fund, a part of Canada’s Biomanufacturing and Life Sciences Strategy.

AML Trial Eligibility Criteria Disparities Highlighted at ASCO 2024

  • A study presented at ASCO 2024 reveals that patients from minoritized populations with acute myeloid leukemia (AML) are less likely to meet clinical trial eligibility criteria compared to Non-Hispanic White patients.
  • Key eligibility criteria contributing to disparities include prior malignancy, prolonged interval, coronary artery disease, and pre-existing conditions like hepatitis B, varying among different ethnic groups.
  • Non-Hispanic White patients had a 5% to 20% higher likelihood of meeting trial eligibility criteria, with significant differences observed across Hispanic, non-Hispanic Asian, and non-Hispanic Black populations.
  • The findings underscore the urgent need for more inclusive trial designs and eligibility criteria that consider the diverse health profiles of all patient populations to ensure equitable access to clinical trials.

Ensitrelvir Shows Promise in Reducing COVID-19 Symptom Development in Exploratory Trial

  • An exploratory phase 2b/3 trial suggests that ensitrelvir may reduce the risk of developing COVID-19 symptoms in asymptomatic or mildly symptomatic individuals.
  • The study found a 77% reduction in the risk of developing any of 14 COVID-19 symptoms or fever with the 125-mg dose of ensitrelvir compared to placebo.
  • Ensitrelvir demonstrated statistically significant antiviral efficacy, reducing viral RNA, viral titer, and time to infectious viral clearance versus placebo.
  • The treatment was generally well-tolerated, with most treatment-related adverse events being mild to moderate in severity.

LSU Health Shreveport to Explore Psilocybin for Methamphetamine Addiction Treatment in Clinical Trial

  • LSU Health Shreveport is launching a clinical trial to investigate psilocybin as a potential treatment for methamphetamine addiction.
  • The trial will be led by Dr. Shawn McNeil, Kevin Murnane, PhD, and PhD candidate Frances Vest at the Louisiana Addiction Research Center.
  • The study aims to address the prevalence of methamphetamine addiction and explore new therapeutic avenues using psilocybin.
  • Researchers will assess the efficacy of psilocybin in reducing addiction-related behaviors and improving mental health outcomes.

Real-World Data Emulation Study Challenges Clinical Trial Findings on Apixaban and Warfarin

  • Researchers emulated a clinical trial using real-world data to compare apixaban and warfarin for stroke prevention in atrial fibrillation patients.
  • The emulation study found similar outcomes for both drugs, differing from the original trial that favored apixaban.
  • Discrepancies may stem from better warfarin control, suboptimal apixaban dosing, and differences in patient ethnicity and concomitant medication use.
  • The approach could help assess treatment effects in underrepresented groups and validate trial results in real-world settings.

FDA Issues New Guidance to Enhance Diversity and Efficiency in Clinical Trials

  • The FDA has finalized guidance on decentralized clinical trials (DCTs), enabling study activities at patients' homes and local healthcare facilities.
  • New FDA guidance emphasizes the need for diverse patient populations in clinical trials, requiring sponsors to submit Diversity Action Plans (DAPs).
  • The FDA encourages oncology sponsors to conduct multiregional clinical trials (MRCTs) while ensuring results are applicable to U.S. populations and healthcare practices.
  • The FDA promotes integrating real-world evidence (RWE) and data from diverse sources, such as electronic health records (EHRs), to support clinical development.

Phase 2 Trial Assesses Felodipine Tolerability for Huntington's Disease

  • A Phase 2 clinical trial (FELL-HD) is underway to evaluate the tolerability of felodipine in patients with early-stage Huntington's Disease (HD).
  • The open-label, dose-finding study will enroll 18 participants aged 35-70 with genetically confirmed HD to test three different doses of felodipine over 58 weeks.
  • The primary outcome is the number of adverse events, with secondary outcomes including quality of life, cognitive and motor function, and biomarker changes.
  • Felodipine, an approved hypertension drug, has shown autophagy-inducing effects in preclinical HD models, potentially aiding in the degradation of toxic mutant huntingtin protein.

Keytruda Fails in Phase 3 Trials for Early-Stage Lung and Skin Cancer

  • Merck's Keytruda, when added to standard treatments, failed to improve survival in patients with early-stage non-small cell lung cancer in the KEYNOTE-867 trial.
  • Similarly, Keytruda did not demonstrate a statistically significant improvement in recurrence-free survival for cutaneous squamous cell carcinoma patients after surgery and radiation in the KEYNOTE-630 trial.
  • Due to the lack of efficacy and increased side effects, including fatal adverse events in the lung cancer trial, both studies were halted early based on independent data analysis recommendations.
  • These setbacks challenge Merck's strategy to broaden Keytruda's applications before its patent expiration, despite significant investment in its development.
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy