Articles related to CLINICAL TRIALS

The incidence of hospitalization or an emergency department visit (observation for more than 6 hours) was significantly lower among those who received a single dose of pegylated interferon lambda than among those who received a placebo.

Per Svenningsson, MD, PhD, a neurologist with expertise in Parkinson’s disease, will serve as the multicenter trial’s principal investigator. He previously oversaw a clinical study using montelukast (Singulair) tablets to treat PD. The multicenter trial is anticipated to begin between July and September. During the 18-month trial, participants will be randomized to receive either montelukast VersaFilm or a placebo film. IntelGenx plans to use the results to enhance the clinical development of its montelukast VersaFilm for Parkinson’s.

NAPOLI-3 began recruiting 770 patients with metastatic pancreatic ductal adenocarcinoma at the start of the COVID-19 pandemic. Until the disease progressed, there was unacceptable toxicity, or the patient withdrew from the study, the patients were randomly randomized to receive the combination of liposomal irinotecan with 5-fluorouracil/leucovorin and oxaliplatin (NALIRIFOX) or nab-paclitaxel plus gemcitabine therapy. OS served as the study’s primary endpoint, whereas progression-free survival (PFS) and the objective response rate (ORR) served as secondary objectives. The main goal of the study—prolonged overall survival—was achieved with NALIRIFOX. The survival curves split at around 3 months, and this divergence was maintained for the duration of the investigation. NALIRIFOX also increased the median PFS. Moreover, NALIRIFOX therapy was preferred in all previously identified categories in terms of both OS and PFS. The ORR with NALIRIFOX was 41.8%, and the ORR with nab-paclitaxel/gemcitabine was 36.2%, virtually entirely made up of incomplete responses.

An inhibitor of poly(ADP-ribose) polymerase (PARP), rucaparib, demonstrated high levels of efficacy in patients with metastatic, castration-resistant prostate cancer coupled with a harmful BRCA change in a phase 2 research. To support and add to the findings of the phase 2 trial, data are required.

248 patients with blood pressures of 130/80 mm Hg or higher despite treatment with at least three antihypertensive agents were randomized to baxdrostat once daily for 12 weeks vs. placebo. The aldosterone synthase inhibitor generated dose-related reductions in blood pressure of 8 to 11 mmHg vs. placebo.

Based on prior studies in patients with melanoma and lung cancer as well as overall response and duration of response rates in open-label, multiple cohort trials involving 131 adults and 36 children, the combination was approved for the new indication (treatment of unresectable or metastatic solid tumors with a BRAF V600E mutation in patients ≥6 years old who have progressed following prior treatment and have no satisfactory alternative treatment options). Adults with BRAF V600E mutation-positive solid tumors, such as low-grade glioma (LGG), anaplastic thyroid cancer, biliary tract cancer, small intestine cancer, and high-grade glioma (HGG), were enrolled in the new trials, along with 36 children with BRAF V600 refractory or recurrent LGG or HGG. The overall response rate (ORR) served as the trial’s main measure of success, and out of the 131 adults who participated, 54 (41%) had an objective reaction. Among the most prevalent tumor types in the clinical trials, the ORR for biliary tract cancer was 46%, HGG was 33%, and LGG was 50%. Children’s ORR was 25%.