Phase Ib Serial Measurements of Molecular and Architectural Responses to Therapy Trial (SMMART)
Summary
The purpose of this phase Ib study is to assesses the feasibility and safety of a personalized medicine approach that utilizes a series of clinical study analytics to characterize the cancer based on DNA mutations, RNA and protein expression, physical and molecular architecture of the cancer tissue, and function of cells. This clinical study analytics will be considered by a tumor board to select therapeutic drug combinations tailored to each individual. The chosen drugs are intended to optimally inhibit and/or perturb biological pathways promoting the growth and/or survival of an individual participant's cancer. Serial biopsies and analytics will allow for the therapy to adapt as the patient's cancer adapts to biological perturbation. The study will include patients with advanced cancer of the breast (BCa), prostate (PCa), or pancreas (PanCa), or those with refractory acute myelogenous leukemia (AML).
General Information
NCT#: NCT03878524
Study ID: STUDY00015588
Trial Phase: Phase I
Trial Sponsor: Oregon Health & Science University Knight Cancer Institute
Therapies Used in This Trial: Fluorouracil, Erlotinib, Oxaliplatin, Ipilimumab, Vorinostat, Dasatinib, Panobinostat, Bortezomib, Pertuzumab, Everolimus, Sorafenib, Celecoxib, Bevacizumab, Leucovorin, Olaparib, Carboplatin, Sunitinib, Ruxolitinib, Cabozantinib, Sirolimus, Nivolumab, Trametinib, Enzalutamide, Pembrolizumab, Afatinib, Idelalisib, Palbociclib, Vemurafenib, Abiraterone, Venetoclax, All-trans retinoic acid (ATRA), Cabazitaxel, Imatinib, Lenvatinib, Ponatinib