Date: 2010-10-12
Type of information: Initiation of the trial
phase: 1b-2a
Announcement: initiation of the trial
Company: Eli Lilly (USA - IN)
Product: galunisertib
Action
mechanism: kinase inhibitor. Galunisertib (LY2157299) is a TGF beta R1 kinase inhibitor that in vitro selectively blocks TGF beta signaling. TGF beta promotes tumors growth, suppresses the immune system, and increases the ability of tumors to spread in the body. Immune function is suppressed in cancer patients, and TGF beta worsens immunosuppression by enhancing the activity of immune cells called T regulatory cells. TGF beta also reduces immune proteins, further decreasing immune activity in patients Galunisertib is currently under investigation as an oral treatment for advanced/metastatic malignancies, including Phase 2 evaluation in hepatocellular carcinoma, myelodysplastic syndromes (MDS), glioblastoma, and pancreatic cancer.
Disease: glioma
Therapeutic area: Cancer - Oncology
Country: Germany, Spain, USA
Trial
details: The purpose of this trial is to show proof of concept that by blocking the Transforming Growth Factor-beta signaling pathway in patients with Glioblastoma, there will be clinical benefit. Phase 1b: To determine the safe and tolerable dose of LY2157299 in combination with radiochemotherapy with temozolomide for Phase 2 in patients with glioma eligible to receive radiochemotherapy with temozolomide (e.g. newly diagnosed malignant glioma World Health Organization Grade III and IV). Phase 2a: To confirm the tolerability and evaluate the pharmacodynamic effect of LY2157299 in combination with standard radiochemotherapy in patients with newly diagnosed glioblastoma. (NCT01220271)
Latest
news: * On October 12, 2010, a Phase 1b/2a trial sponsored by Eli Lilly was published on the NIH website ClinicalTrials.gov galunisertib and is currently ongoing.