Date: 2016-04-04
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Curis (USA - MA)
Product: CUDC-907 - mesylate synthetic small molecule inhibitor of HDAC and PI3K
Action
mechanism: histone deacetylase inhibitor/phosphoinositide 3-kinase (PI3K) inhibitor. CUDC-907 is an oral, dual inhibitor of histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) enzymes that is currently under investigation in Phase 1 clinical studies in patients with relapsed or refractory lymphomas or multiple myeloma as well as in patients with advanced/ relapsed solid tumors, including hormone receptor positive (HR+)/ HER2-negative breast cancer or midline carcinoma with certain NUT gene rearrangements.
Disease: relapsed and/or refractory diffuse large B-cell lymphoma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This is a Phase 2, open-label, multicenter trial designed to evaluate the efficacy and safety of CUDC-907 monotherapy and R-907 (rituximab in combination with CUDC-907) in subjects 18 years and older with Relapsed/Refractory (RR) MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL). (NCT02674750)
Latest
news: * On April 4, 2016, Curis announced that based on the clinical activity observed in patients with relapsed/ refractory-DLBCL, particularly those with cancers harboring MYC alterations, the company has initiated a Phase 2 trial to evaluate CUDC-907 in patients with MYC-altered relapsed and/or refractory diffuse large B-cell lymphoma. In this trial, approximately 120 patients with relapsed/refractory disease will be randomly assigned to receive CUDC-907 as monotherapy or CUDC-907 with the standard dose of rituximab. Patients will remain on treatment until progression of disease, discontinuation for safety reasons, or other reasons for treatment discontinuation. The primary endpoint of the trial is objective response rate with secondary endpoints that include progression free survival, overall survival and duration of response. Positive results with CUDC-907 monotherapy will lead to an expansion of patient enrollment and discussion with the FDA regarding potential registration strategy in this patient population. The rituximab combination treatment arm of the Phase 2 trial is intended to inform the design of a confirmatory, randomized trial of CUDC-907 in combination with rituximab as compared to rituximab in combination with standard of care chemotherapy.
