Date: 2016-06-14
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: PharmaMar (Spain)
Product: plitidepsin
Action
mechanism: depsipeptide derivative. Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the tunicateAplidium albicans. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apoptosis (programmed death). Plitidepsin is currently in clinical development for hematological cancers, including a Phase III study in relapsed or refractory multiple myeloma, a Phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. Plitidepsin has received orphan drug designation by the EMA and the FDA.
Disease: angioimmunoblastic T-cell lymphoma
Therapeutic area: Cancer - Oncology - Rare diseases
Country:
Trial
details: This pivotal clinical trial will include 60 patients from approximately 25 investigative sites. The primary objective is to analyze the efficacy of plitidepsin in terms of overall response rate, to be evaluated by an independent committee following the Lugano classification response criteria. The secondary endpoint will be to evaluate other efficacy parameters such as duration of response, progression free survival and overall survival; the pharmacokinetic characteristics, the safety profile of plitidepsina and the identification of possible biomarkers that help to identify the
predictive activity of the compound.
Latest
news: * On June 14, 2016, PharmaMar announced the start of a multicenter, prospective, pivotal study to analyze the efficacy of plitidepsin in patients with relapsed and refractory angioimmunoblastic T-cell lymphoma. As this is classified as a rare disease, and in consultation with the FDA, the study has been designed with only one study arm.
