The main purpose of this open-label, dose-escalation, phase Ib study is to identify the
appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without
Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03767335.
Locations matching your search criteria
United States
Maryland
Baltimore
University of Maryland/Greenebaum Cancer CenterStatus: Active
Contact: Nancy S. Tait
Phone: 410-328-3546
This Phase Ib study will investigate the safety and anti-tumor activity of daily oral
doses MEN1611 in combination with Trastuzumab with/without Fulvestrant in female and male
patients affected by advanced or metastatic HER2-positive breast cancer. Fulvestrant will
be added to the post-menopausal patients with hormone-sensitive disease.
MEN1611 is an investigational drug which blocks a protein called PI3K (phosphoinositide
3-kinase) involved in cancer cells growth. The Maximum Tolerated Dose (MTD) of MEN1611
given as single agent was assessed in a phase I trial in patients with advanced solid
tumors.
This Phase IB will start with a dose escalation part (Step 1) to identify the MTD of
MEN1611 given in combination with Trastuzumab with/without Fulvestrant.
The study will continue with a cohort expansion (Step 2) to investigate the anti-tumor
activity of the selected MEN1611 dose level considered to be tolerable by a Safety Review
Committee.
Lead OrganizationMenarini Group
