Clinical Trial News

A phase 3 trial tested niraparib vs. placebo in 553 patients with recurrent ovarian cancer, stratified by gBRCA mutation status. Primary outcome was PFS, with secondary outcomes including OS and safety. The study was randomized, double-blind, and placebo-controlled, showing low risk of bias across assessed domains.

A pilot study found high satisfaction (87.5%) and continuation rates (87.5%) for the etonogestrel contraceptive implant when placed on the day of mifepristone administration for medical abortion, suggesting feasibility of this approach.

Ruxolitinib, a JAK1/JAK2 inhibitor, significantly improves splenomegaly and symptoms in intermediate-2 or high-risk myelofibrosis patients, as shown in COMFORT-I and COMFORT-II trials. Despite dose-dependent anemia and thrombocytopenia, adverse effects were manageable. Long-term data confirm durable benefits across patient subgroups, with potential survival improvement.

4SC AG announced positive Phase I results for resminostat combined with FOLFIRI in advanced CRC, showing safety, tolerability, and clinical activity. Encouraging biomarker data from Phase II trials in HCC and HL suggest ZFP64 gene expression as a potential biomarker for resminostat treatment outcomes. 4SC plans further development and discussions with partners and regulators.

Prucalopride 2 mg significantly improved bowel function in chronic constipation patients from the Asia-Pacific region over 12 weeks, with 33.3% achieving ≥3 spontaneous complete bowel movements per week vs 10.3% on placebo (P < 0.001). It was safe, well-tolerated, with common adverse events being diarrhea, nausea, abdominal pain, and headache.

Four U.S. trials on post-treatment Lyme syndrome showed mixed results on antibiotic therapy's efficacy. Two trials found IV ceftriaxone effective for fatigue, but its use is limited by adverse effects. Guidelines should acknowledge these findings, emphasizing the need for safer treatments and clearer criteria for patient selection.

A comprehensive study across multiple clinics in the U.S. and Europe has confirmed the efficacy of ulipristal acetate as an emergency contraceptive, showing a significant reduction in pregnancy rates when administered within 48 to 120 hours after unprotected intercourse. The study also compared its effectiveness and safety profile with levonorgestrel, another emergency contraceptive, finding ulipristal acetate to be non-inferior and well-tolerated.

GIP reduces free fatty acid (FFA) release from adipose tissue by inhibiting 11β-HSD1 activity, affecting lipid metabolism. A clinical trial showed GIP lowers circulating FFAs and reduces 11β-HSD1 and ATGL expression in human adipose tissue, indicating GIP's direct, insulin-independent effects on adipose tissue metabolism.

The FDA approved Xarelto, a next-gen blood thinner, for atrial fibrillation treatment, offering an alternative to warfarin. Xarelto, effective once daily, blocks clotting protein factor Xa, similar in stroke prevention to warfarin but with a boxed warning against abrupt discontinuation due to stroke risk.

A comprehensive analysis of the Diabetes Prevention Program (DPP) and its Outcomes Study (DPPOS) reveals that lifestyle changes and metformin significantly reduce the risk of developing diabetes. Adherent participants to these interventions experienced a lower incidence of diabetes and accrued more quality-adjusted life-years (QALYs) compared to those on placebo. The study also highlights the cost-effectiveness of these interventions from a health system perspective, with lifestyle and metformin interventions being cost-saving relative to placebo.