The Princess Margaret Phase I Consortium (PMPIC), led by Dr. Lillian Siu, consists of the Princess Margaret Cancer Centre (PM) as its Lead Academic Organization (LAO) and three Affiliated Organizations (AO): Moffitt Cancer Center (MCC), Juravinski Cancer Centre (JCC) and British Columbia Cancer Agency (BCCA).
The Specific Aims of PMPIC resonate closely with the goals of the ET-CTN: 1)To conduct innovative, coordinated, efficient, regulatory-compliant and high impact early phase clinical trials in experimental therapeutics, which are designed to address important questions that do not duplicate research supported by the pharmaceutical industry or other sources;2) To adopt a team science interdisciplinary approach with internal and external collaborations to enhance the optimal evaluation of novel anticancer agents alone or in combination;3) To accelerate biomarker development and correlative sciences research through comprehensive molecular characterization of tumors obtained from patients enrolled on ET-CTN trials to elucidate mechanism of action, as well as predictors of therapeutic response and/or resistance;and 4) To emphasize training and education to foster career development of junior investigators. PMPIC is committed to actively lead ET-CTN early phase trials as well as to contribute as a meaningful partner to ET-CTN trials led by other Consortia. With a strong Leadership that is supported by the Steering Committee, Translational Research, Clinical Research and Operational Cores, PMPIC embraces a team science approach to conduct the most relevant early phase clinical trials of novel agents alone or in combination. All patients enrolled by the PMPIC will undergo comprehensive molecular characterization using advanced genotyping or targeted sequencing approaches to help identify drivers of drug sensitivity or resistance. This data, along with pharmacological, immune function, and quantitative imaging data, will enable the most optimal biological correlation with clinical outcome. Leveraging resources from other sources including institutional support, the PMP1C will further advances whole exome/whole genome next generation sequencing technologies within the timeframe of this award in the next 5 years.

Public Health Relevance

Cancer is a leading cause of death and suffering worldwide and efforts at controlling and curing this disease remain a top health care priority. The Princess Margaret Phase I Consortium plans to conduct early phase clinical trials of new anticancer treatments or combination to determine their safety profile, to understand the biological mechanisms of these new treatments, and to help identify patients who are most likely to respond.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel ()
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Ivy, S Percy
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University Health Network
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M5 2-M9
Day, Daphne; Monjazeb, Arta M; Sharon, Elad et al. (2017) From Famine to Feast: Developing Early-Phase Combination Immunotherapy Trials Wisely. Clin Cancer Res 23:4980-4991
Siu, Lillian L; Ivy, S Percy; Dixon, Erica L et al. (2017) Challenges and Opportunities in Adapting Clinical Trial Design for Immunotherapies. Clin Cancer Res 23:4950-4958
Baik, Christina S; Rubin, Eric H; Forde, Patrick M et al. (2017) Immuno-oncology Clinical Trial Design: Limitations, Challenges, and Opportunities. Clin Cancer Res 23:4992-5002
Chiu, Joanne W; Hotte, Sebastien J; Kollmannsberger, Christian K et al. (2016) A phase I trial of ANG1/2-Tie2 inhibitor trebaninib (AMG386) and temsirolimus in advanced solid tumors (PJC008/NCI?9041). Invest New Drugs 34:104-11
Cook, Natalie; Hansen, Aaron R; Siu, Lillian L et al. (2015) Early phase clinical trials to identify optimal dosing and safety. Mol Oncol 9:997-1007
How, Jonathan; Minden, Mark D; Brian, Leber et al. (2015) A phase I trial of two sequence-specific schedules of decitabine and vorinostat in patients with acute myeloid leukemia. Leuk Lymphoma 56:2793-802
Siu, Lillian L; Conley, Barbara A; Boerner, Scott et al. (2015) Next-Generation Sequencing to Guide Clinical Trials. Clin Cancer Res 21:4536-44
Reiss, Kim A; Herman, Joseph M; Zahurak, Marianna et al. (2015) A Phase I study of veliparib (ABT-888) in combination with low-dose fractionated whole abdominal radiation therapy in patients with advanced solid malignancies and peritoneal carcinomatosis. Clin Cancer Res 21:68-76
LoConte, Noelle K; Razak, Albiruni R A; Ivy, Percy et al. (2015) A multicenter phase 1 study of ? -secretase inhibitor RO4929097 in combination with capecitabine in refractory solid tumors. Invest New Drugs 33:169-76
Richter, Suzanne; Bedard, Philippe L; Chen, Eric Xueyu et al. (2014) A phase I study of the oral gamma secretase inhibitor R04929097 in combination with gemcitabine in patients with advanced solid tumors (PHL-078/CTEP 8575). Invest New Drugs 32:243-9

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