The Alliance for Clinical Trials in Oncology today announced that an independent Data and Safety Monitoring Board (DSMB) determined that the phase III CABINET (A021602) pivotal trial met its primary endpoint at an interim analysis in both of the trial's cohorts, demonstrating statistically significant and clinically meaningful improvements in progression-free survival (PFS).
CABINET is evaluating cabozantinib compared with placebo in patients with either advanced pancreatic neuroendocrine tumors or advanced extra-pancreatic neuroendocrine tumors who experienced progression after prior systemic therapy. The DSMB recommended the study stop early due to efficacy and findings will be discussed with the U.S. Food and Drug Administration. Detailed results from the trial will be presented at an upcoming scientific meeting.
"These promising findings from the CABINET trial, in which cabozantinib showed an efficacy benefit for patients with pancreatic and extra-pancreatic neuroendocrine tumors, are welcome news and show the potential for cabozantinib to address important unmet needs for this community." . The results of CABINET add to this important work to further improve the outcomes of patients with the rare tumors of pancreatic and extra-pancreatic NET," said Suzanne George, MD, Interim Group Chair of the Alliance, Associate Professor of Medicine at Harvard Medical School and Clinical Director at the Center for Sarcoma and Bone Oncology at Dana-Farber Cancer Institute.
Patients were randomized 2:1 into the cabozantinib or placebo arms of the study in each of the two cohorts. Patients must have had measurable disease per RECIST 1.1 criteria and must have experienced disease progression after at least one FDA-approved line of prior therapy other than somatostatin analogs. The primary endpoint was PFS in each cohort.
Belgique Dernières Nouvelles, Belgique Actualités
Similar News:Vous pouvez également lire des articles d'actualité similaires à celui-ci que nous avons collectés auprès d'autres sources d'information.
What are the needs for clinical application of next-generation sequencing for microbiological diagnosis?Scientists have surveyed to understand the need for clinical application of next-generation sequencing in microbiology laboratories.
Lire la suite »
Fans handed insight into trials and tribulations of Liverpool Feds in new filmLiverpool Feds are the subject of a new documentary that shines a light on life in the third tier of the women's game
Lire la suite »
FDA approving drugs after fewer trials, providing less information to public, studies findThe U.S. Food and Drug Administration is approving more novel pharmaceutical drugs based on single clinical trials and with less public disclosure about those trials than was the norm just a few years ago, a pair of recent studies from Oregon State University has found.
Lire la suite »
Project NextGen awards over $1.4 billion to develop the future of COVID-19 vaccines and therapeuticsFunding includes $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody, and $100 million to explore novel vaccine and therapeutic technologies.
Lire la suite »
Pulmonary artery catheter use in cardiac surgery patients: Study reveals varied impact on hospital stay and mortality ratesThe relationship between pulmonary artery catheter (PAC) use and clinical outcomes in cardiac surgery.
Lire la suite »
Alzheimer's symptoms may be reduced by simple eating habit used for weight lossThe recent study, which was carried out in mice, will likely lead to a clinical trial in humans.
Lire la suite »