What are Phase I Clinical Trials

Clinical trials are human studies designed to ethically evaluate new treatments. The assessment of new cancer treatments progresses through several phases, starting with Phase I trials. 

Phase I trials look at how well a new treatment is tolerated and are used to determine the highest dosage that can be safely given. In general, phase I trials evaluate the promising drugs that have shown activity in the lab and in animal models and/or new drug combinations. Phase I trial participation can be offered to patients who have advanced cancer that cannot be treated effectively with standard treatments or for which no standard treatment exists. Although evaluating the effectiveness of interventions is not a primary goal of these trials, physicians and researchers do look for evidence that an intervention might be useful.

 

CCI Phase I

The CCI CTU (Cross Cancer Institute Clinical Trials Unit) has an active Phase I unit. Phase I studies enroll patients to first-in-human drug studies, with careful pharmacokinetic and adverse-event monitoring. The Phase 1 program is based on studies that provide leading-edge treatments that have never been trialed in patients. These new drug studies could lead to new standard therapies for patients. There are limited numbers of investigators nationally that have Phase 1 clinical trials expertise. Therefore, there are few Phase 1 trials conducted in Canada. The CCI has four medical oncologists with formal postgraduate training, who treat approximately 70 new patients annually. 


The Phase I catchments area is a large referral base, including Alberta, Northeastern BC, Saskatchewan, the Northwest Territories and Eastern Manitoba. We have also provided care to patients from Ontario and the Northwestern US. 


Industry collaborations include AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eisa, Genentech, Johnson & Johnson, Novartis, Pfizer, Piramal Life Sciences, and Wyeth.

 


TBCC Phase I

T

he TBCC CTU has recently established a Phase I unit. This unit enrolled 12 patients into cutting-edge drug studies requiring careful pharmacokinetic and adverse-event monitoring during 2011. This unit aims to develop a Phase I track record to emulate that established at the CCC and intends to enroll 15 patients to Phase I trials for the new year. 

Current Phase I infrastructure at the TBCC includes: 
•    A dedicated Phase I drug delivery suit near the chemotherapy delivery room; 
•    A sophisticated in-house pharmacokinetic (PK) laboratory at the Tom Baker Cancer Centre that supports clinical trials research by providing analytical analysis of chemotherapy agents and metabolites via mass spectrometry coupled with liquid chromatography; 


On-site pharmacokinetic expertise is provided by a PK scientist enabling protocol design, sampling strategy, and PK data analysis, modeling and using FDA-approved (US Food & Drug Administration) pharmacokinetic software.