close

Clinical Trials

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.

Is general: Yes