Date: 2016-03-14
Type of information: Halting of the trial
phase: 3
Announcement: halting of the trial
Company: Immunomedics (USA - NJ)
Product: yttrium-90- labeled (90Y) clivatuzumab tetraxetan
Action
mechanism: monoclonal antibody/radioconjugate. Clivatuzumab is a humanized monoclonal antibody targeting a mucin antigen expressed in most pancreatic cancers, but not pancreatitis, normal pancreas or most other normal tissues. The yttrium-90-labeled antibody has Orphan Drug status in both the United States and the European Union and fast track status in the U.S. for the treatment of pancreatic cancer.
Disease: metastatic pancreatic cancer
Therapeutic area: Cancer - Oncology
Country: Austria, Belgium, Canada, France, Israel, Poland, Spain, USA
Trial
details: The PANCRIT-1 study is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen). (NCT01956812)
Latest
news: * On March 14, 2016, Immunomedics announced that the Company is terminating the Phase 3 PANCRIT-1 trial with yttrium-90- labeled (90Y) clivatuzumab tetraxetan in patients with metastatic pancreatic cancer who had
received at least two prior therapies, one of which must have been a gemcitabine-containing regimen.
The decision to terminate the trial early is based on the recommendation from the independent Data and Safety Monitoring Board (DSMB), following a planned interim analysis of data on overall survival (OS) after more than 50% of the required 371 deaths had occurred. The interim analysis showed that the treatment arm of 90Y-clivatuzumab tetraxetan combined with low-dose gemcitabine and best supportive care did not demonstrate a sufficient improvement in OS as compared to placebo plus low-dose gemcitabine and best supportive care.
