Date: 2016-04-20
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Abbvie (USA - IL) Genentech, a member of Roche Group (USA - CA - Switzerland)
Product: venetoclax (RG7601, GDC-0199/ABT-199)
Action
mechanism: protein inhibitor/B-cell lymphoma 2 (BCL-2) inhibitor. Venetoclax (RG7601, GDC-0199/ABT-199 is an investigational small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). It is believed that blocking BCL-2 may restore the signaling system that tells cancer cells to self-destruct. The BCL-2 protein is linked to the development of resistance in certain blood cancers and is expressed in chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL). In collaboration with AbbVie, venetoclax is being evaluated in a robust development program as a single agent or in combination with other medicines. There are ongoing Phase II and III studies for venetoclax in CLL, and Phase I and II studies are also ongoing in several other blood cancers, including indolent NHL, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and multiple myeloma (MM). Venetoclax was recently granted Breakthrough Therapy Designation by the FDA for the treatment of previously treated CLL with the 17p deletion.
Disease: relapsed/refractory multiple myeloma
Therapeutic area: Cancer - Oncology
Country: Australia, Canada, France, Germany, Hungary, Italy, Japan, Republic of Korea, Russian Federation, USA
Trial
details: This is a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in subjects with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma. (NCT02755597)
Latest
news: * On April 20, 2016, a new Phase 3 trial with venetoclax was published on ClinicalTrials.gov (A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy).
