Date: 2013-03-14
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: AstraZeneca (UK)
Product: selumetinib
Action
mechanism: tyrosine kinase inhibitor/MEK inhibitor. Selumetinib is an oral, potent, selective MEK inhibitor, which has been shown to be effective as monotherapy and in combination with standard chemotherapy regimens in Phase I and Phase II clinical studies across a range of solid tumours, which support the development of selumetinib in patients with MEK-dependent cancers. MEK is part of the MAPK pathway which is frequently activated in cancer, and is elevated in many different solid tumour types, including those featuring the KRAS mutation, which is present in 20% of human cancers and 20-30% of NSCLC tumours. AstraZeneca acquired exclusive worldwide rights to selumetinib from Array. To date, Array received $26.5 million in up-front and milestone payments and is entitled to potential additional development milestone payments of approximately $70 million (with $30 million specific for selumetinib) and royalties on product sales.
Disease: differentiated thyroid cancer
Therapeutic area: Cancer - Oncology
Country: Brazil, Denmark, France, Germany, Italy, Poland, Sweden, USA
Trial
details: The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer. (NCT01843062)
Latest
news: * On March 14, 2013, a Phase 3 trial sponsored by AstraZenca was published on the NIH website ClinicalTrials.gov for selumetinib and is currently ongoing.
