Date: 2016-02-26
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: PharmaMar (Spain)
Product: PM184
Action
mechanism: antimicrotubule agent/microtubule inhibitor. PM184 is a marine-derive drug found in the sponge Lithoplocamia lithistoides. This microtubule inhibitor targets tubulin in a novel way. It blocks cancer growth by impairing cell division of tumor cells through the inhibition of a crucial process called mitosis.
Disease: advanced breast cancer, hormone-receptor positive,HER2-negative, locally advanced and/or metastatic breast cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On February 26, 2016, PharmaMar has announced the start of an open-label multi-centre two-stage Phase II trial with PM184. The trial will be conducted in 10 European clinical centres and will include 106 patients. The trial will focus on patients with hormone-receptor positive,HER2-negative, locally advanced and/or metastatic breast cancer, who have experienced progression following earlier treatment with anthracyclines and taxanes. The second stage of this Phase II trial will be randomised vs. investigator's best choice, to assess the efficacy and safety of PM184. The trial will also assess safety and pharmacological profiles in the target population, and perform pharmacogenetic analyses to examine inter-patient variations in the transformation and elimination of PM184, together with pharmacogenomic studies that will contribute to identifying predictors of the response to the drug.
The primary endpoint is to evaluate the efficacy of PM184 with regard to fourmonth progression free survival (PFS). Secondary endpoints include analysing a more convenient administration pattern for PM184, overall survival, median PFS, overall response, and response duration measured in accordance with RECIST (Response Evaluation Criteria In Solid Tumors) Guideline Version 1.1.
