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Clinical Trial News

Topotecan Shows Significant Activity in Second-Line Treatment of Small-Cell Lung Cancer

  • Topotecan demonstrates notable efficacy in treating small-cell lung cancer (SCLC) patients who have previously undergone chemotherapy.
  • The study reveals a higher response rate among patients sensitive to prior chemotherapy, with an overall response rate of 37.8%.
  • Hematologic toxicity, particularly neutropenia, was the primary adverse effect, but it was generally manageable and short-lived.
  • The findings suggest that topotecan could be a valuable component in future combination chemotherapy regimens for SCLC.

Naltrexone Shows Promise in Reducing Fatigue in Primary Sjögren’s Syndrome

  • A prospective, open-label study suggests low-dose naltrexone (LDN) may alleviate fatigue in patients with primary Sjögren’s syndrome (pSS).
  • The study observed a statistically significant reduction in fatigue scores, as measured by the Fatigue Severity Scale (FSS), following LDN treatment.
  • LDN was well-tolerated, with no serious adverse events reported, indicating a favorable safety profile for pSS patients.
  • These findings support further investigation of LDN as a potential therapeutic option for managing fatigue, a common and debilitating symptom of pSS.

Ropeginterferon Alfa-2b Evaluated as Second-Line Therapy for High-Risk Essential Thrombocythemia in SURPASS-ET Trial

  • The SURPASS-ET trial is evaluating ropeginterferon alfa-2b as a second-line treatment for high-risk essential thrombocythemia (ET).
  • This Phase III trial compares ropeginterferon alfa-2b to anagrelide in patients resistant to or intolerant of hydroxyurea.
  • Ropeginterferon alfa-2b, a long-acting interferon, has shown a good safety profile in polycythemia vera and may offer a new option for ET patients.
  • The study assesses the safety, efficacy, tolerability, and pharmacokinetics of ropeginterferon alfa-2b, addressing an unmet need for effective ET therapies.

Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance

NCT04285086Active, Not RecruitingPhase 3
PharmaEssentia
Posted 8/25/2020

Pre-Transplant MRD Positivity Linked to Poorer Survival in Acute Leukemia Patients

  • A study of 114 acute leukemia patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) reveals that pre-transplant minimal residual disease (MRD) positivity is associated with worse outcomes.
  • Patients with MRD+ status before transplantation had significantly lower one-year overall survival (OS) and progression-free survival (PFS) rates compared to MRD- patients.
  • Multivariate analysis identified MRD positivity as an independent prognostic factor for overall survival, highlighting the need for improved pre-transplant MRD management strategies.
  • The research suggests focusing on more effective chemo regimens with targeted agents to achieve MRD- status before transplantation and better management of GvHD prophylaxis.

Abemaciclib Shows Promise in ER+/HER2- Advanced Breast Cancer Treatment

  • Abemaciclib, a CDK 4/6 inhibitor, presents a valuable therapeutic avenue for patients with ER+/HER2- advanced metastatic breast cancer, offering a continuous dosing schedule unlike other CDK 4/6 inhibitors.
  • Clinical trials demonstrate that abemaciclib provides similar clinical benefits to palbociclib and ribociclib in first- and second-line treatments, but with a distinct toxicity profile.
  • The ongoing MONARCH-E trial exploring abemaciclib in the adjuvant setting for high-risk, node-positive patients could significantly broaden its impact in early breast cancer treatment.
  • Biomarker research from studies like neoMONARCH may help identify tumors most responsive to abemaciclib, optimizing its use in personalized treatment strategies.

Psychedelics Show Promise in Treating Anxiety and Depression in Cancer Patients

  • A review of five randomized, double-blind, placebo-controlled trials suggests psychedelics may offer a novel approach for treating anxiety and depression in cancer patients.
  • Studies showed significant reductions in anxiety and depression scores using various scales, with benefits potentially lasting for 6 to 12 months after only a few sessions.
  • The unique mechanism of action of psychedelics may provide relief for patients who do not respond well to traditional antidepressants, addressing a significant unmet need.
  • Despite promising results, the studies were small and had methodological limitations, including observed increases in blood pressure and heart rate.

PLEASE Trial Assesses Prolonged Antibiotic Treatment for Persistent Lyme Symptoms

  • The Persistent Lyme Empiric Antibiotic Study Europe (PLEASE) investigates optimal treatment for borreliosis-attributed persistent symptoms.
  • The study is a randomized, double-blind, placebo-controlled trial comparing short-term versus long-term antibiotic regimens.
  • Researchers aim to determine if prolonged antibiotic treatment improves patient outcomes compared to standard short-term therapy.
  • The trial includes patients with persistent pain, fatigue, and cognitive issues following Lyme disease, evaluating physical and mental health.

Phase III LEAP-012 Study Shows Promising Results for Intermediate-Stage HCC Treatment

The LEAP-012 phase III trial demonstrates that combining lenvatinib, pembrolizumab, and TACE significantly improves progression-free survival in patients with intermediate-stage hepatocellular carcinoma, compared to placebo plus TACE.

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

NCT04246177Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/22/2020

South Korea Emerges as Premier Clinical Trial Hub with $20 Billion Pharmaceutical Market Potential

  • South Korea has established itself as a global clinical trial hub, supported by government incentives, modern infrastructure, and streamlined regulatory processes that rank it among the top 15 countries for clinical trials.
  • The Korean pharmaceutical market is projected to reach $20 billion by 2015, with the government investing $1 billion through the Korea Drug Development Fund to accelerate new drug development.
  • The country offers significant advantages for clinical research, including Western-style medical facilities, high patient literacy rates, and specialized expertise in oncology trials, which comprise one-third of all studies conducted.

Breakthroughs in Oncology: Recent Clinical Trial Findings

Recent clinical trials in oncology have shown promising results, including the success of Elinzanetant in HR-positive breast cancer, the efficacy of a novel therapy in KRASG12C non-small cell lung cancer, and the improved outcomes of nivolumab in SCCHN treatment.
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