North American Star Consortium

This UM1 renewal application is designated the North American Star Consortium (NASC), which includes
Moffitt Cancer Center (MCC) as the Lead Academic Organization (LAO) with Daniel Sullivan, MD as the
contact PI. MCC is joined by four highly productive Academic Organizations (AO) including Princess Margaret
Cancer Center (PMCC; Philippe Bedard, MD, multi-PI), Virginia Commonwealth University-Massey Cancer
Center (VCU-Massey; Steven Grant, MD, multi-PI), University of Texas Southwestern Simmons Cancer Center
(UTSW; Muhammad Beg, MD, multi-PI), and Northwestern Lurie Cancer Center (NWU; Jeffrey Sosman, MD,
multi-PI). The NASC evolved from the Princess Margaret Phase 1 Consortium (PMP1C), where PMCC was the
LAO and MCC and VCU-Massey AOs. The two new sites (UTSW and NWU) bring additional depth in
basic/translational science and biomarker (BM) development, have active early phase clinical trial programs,
prioritize the accrual of minority patients, have active mentorship programs for Early Career Clinical
Investigators (ECIs), and expand the NASC expertise in investigational imaging. The PMP1C has existed from
April 2014 to the present and during this time 14 ETCTN trials have been activated and 4 are pending
activation. The average yearly accrual during this time was 52 patients/year (yearly goal was 50 patients/year),
with 97 patients enrolled March 2018 – February 2019. The 5 NASC institutions have enrolled a total of 1703
patients on their “top 50 trials” (ETCTN + non-ETCTN) with appropriate minority patient accrual, exceptionally
strong mentoring of ECIs, and significant correlative molecular analyses for integrated and exploratory BM.
This productivity of the PMP1C and UTSW/NWU will now go forward with MCC as the LAO to address the
following specific aims. 1. To plan, develop, and activate novel phase 1 and phase 2 ETCTN trials through
participation in the Project Team Member Application mechanism or as investigator-initiated trials (IITs) that
emerge from NASC investigators. The NASC goal is to activate a minimum of six trials/year. 2. To enroll
patients on ETCTN trials from the NASC or other sites that require the acquisition of high-quality tumor tissue
for biomarker and pharmacodynamic analyses, include pharmacokinetic (PK) endpoints, and closely follow
Good Clinical Practice and Human Subject Protection guidelines. The NASC annual accrual goal on ETCTN
trials is a minimum of 100 patients/year (30 at MCC, 20 each at PMCC and VCU-Massey, and 15 each at
UTSW and NWU). 3. To focus on the career development of ECIs within the NASC by providing educational
opportunities regarding clinical research and its regulation at the 5 institutions, by having the ECI serve as the
PI of ETCTN studies and pairing them with senior investigator mentors, and by focusing on ECI exposure and
education regarding biomarkers, correlative molecular analyses, PK studies and precision cancer medicine. 4.
To ensure that ETCTN trials performed at NASC sites have appropriate accrual of minority patients, other
underserved populations, adolescent and young adults, the elderly, and rural populations.

Grant Number: 5UM1CA186644-09
NIH Institute/Center: NIH
Principal Investigator: Philippe Bedard