Date: 2014-11-24
Type of
information: Halting of the trial
phase: 3
Announcement: halting of the trial
Company: Amgen (USA - CA)
Product: rilotumumab
Action
mechanism:
- monoclonal antibody. Rilotumumab is a human monoclonal antibody directed against the human hepatocyte growth factor (HGF) with potential antineoplastic activity. It binds to and neutralizes HGF, preventing the binding of HGF to its receptor c-Met and so c-Met activation; inhibition of c-Met-mediated signal transduction may result in the induction of apoptosis in cells expressing c-Met. c-Met (HGF receptor or HGFR), a receptor tyrosine kinase overexpressed or mutated in a variety of epithelial cancer cell types, plays a key role in cancer cell growth, survival, angiogenesis, invasion, and metastasis.
Disease: advanced gastric cancer
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On November 24, 2014, Amgen announced the termination of all Amgen -sponsored clinical studies of rilotumumab in advanced gastric cancer, including the Phase 3 RILOMET-1 and RILOMET-2 studies. Amgen\'s decision is based on a planned safety review by the RILOMET-1 independent data monitoring committee that found an increase in the number of deaths in the rilotumumab and chemotherapy treatment arm when compared to the chemotherapy treatment only arm. Protocol-defined futility criteria would likely have been met at the planned interim analysis, scheduled for March 2015 . Detailed results of RILOMET-1 will be submitted for presentation and publication. Amgen is in communication with investigators in rilotumumab studies to coordinate study termination and provide guidance for study subject follow-up.
Is
general: Yes
