Date: 2016-08-02
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: PharmaMar (Spain)
Product: PM1183 (lurbinectedin) in combination with doxorubicin
Action
mechanism: transcriptional inhibitor/RNA polymerase II inhibitor. Lurbinectedin is an inhibitor of RNA polymerase II. This synthetic marine-derived compound covalently binds to the minor groove of the DNA. These lurbinectedin-DNA adducts give rise to double strand breaks and perturbations of the cell cycle inducing cell death. Lurbinectedin induces a specific degradation in tumour cells of RNA polymerase II, without interfering other RNA polymerases (I and III)-the degradation depends on whether the transcription process is active (transactivated transcription) and does not affect basal transcription. In preclinical trials, the compound evidenced strong activity against tumour cell lines of different origins. The antitumor efficacy of lurbinectedin is being investigated in various types of solid tumors, including a Phase III study for platinum-resistant ovarian cancer, a Phase II study for BRCA 1 and BRCA 2- associated metastatic breast cancer and a Phase III study for small cell lung cancer.
Disease: small cell lung cancer (SCLC) after the failure of one prior platinum containing line
Therapeutic area: Cancer - Oncology
Country:
Trial
details: ATLANTIS is a multicenter, open-label, randomized, and controlled Phase III clinical trial that is to include 600 patients at clinical sites across 21 countries. The primary endpoint of this study is to improve the progression free-survival (PFS) of those patients that will be evaluated by an Independent Review Committee following Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Secondary objectives include overall survival (OS); duration of the response (DR); along with quality of life indicators; response rate (RR) according to the RECIST 1.1 criteria; and also the correlation between pharmacokinetics and pharmacodynamics. (NCT02566993)
Latest
news: * On August 2, 2016, PharmaMar announced the start of a pivotal Phase III ATLANTIS study evaluating efficacy and safety of PM1183 (lurbinectedin) in combination with doxorubicin versus topotecan or the combination VCR (cyclophosphamide, adriamicine (doxorubicin) and vincristine) in patients with small cell lung cancer (SCLC) after the failure of one prior platinum containing line. In a phase 1b study, PM1183 has demonstrated encouraging results and 67% of the patients responded to the treatment of lurbinectedin in combination with doxorubicin.
