Date: 2017-03-30
Type of
information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Spectrum Pharmaceuticals (USA - NV)
Product: poziotinib
Action
mechanism:
- tyrosine kinase inhibitor. Poziotinib is a novel, oral pan-HER inhibitor that irreversibly blocks signaling through the Epidermal Growth Factor Receptor (EGFR, HER) Family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), and importantly, also HER receptor mutations; this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Currently, poziotinib is being investigated by Hanmi in several mid-stage trials in different solid tumor indications including HER2-positive breast cancer. (Phase 2 sponsored by National OncoVenture, a funding initiative by the Korean government's National Cancer Center).
Disease: non-small cell lung cancer with EGFR exon 20 insertion mutations
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details: The goal of this clinical research study is to learn if poziotinib can help to control EGFR-positive non-small cell lung cancer (NSCLC) that is locally advanced or metastatic (has spread). EGFR-positive NSCLC means that there is a mutation (a type of genetic change) on the EGFR gene. The safety of poziotinib will also be studied .(NCT03066206)
Latest
news:
- • On March 30, 2017, Spectrum Pharmaceuticals announced that the University of Texas MD Anderson Cancer Center initiated a Phase 2 trial of poziotinib in non-small cell lung cancer patients with EGFR exon 20 insertion mutations. This Phase 2 trial will evaluate Objective Response Rate (ORR) as the primary endpoint and is expected to yield preliminary results before year-end.
- The company has recently presented preclinical data from a preclinical study evaluating poziotinib in lung cancer.
Is
general: Yes