Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2018

Conducting early-phase oncology clinical trials: experience of a dedicated clinical trial unit (#325)

James C Kuo 1 , Felicia T Roncolato 1 , Belinda Bahari 1 , Jessica Wharton 1 , Charlotte R Lemech 1
  1. Scientia Clinical Research, Randwick, NSW, Australia

Introduction: Early-phase clinical trial (ECT) activity has increased in Australia over recent years with the establishment of several dedicated clinical trials facilities. Scientia Clinical Research (SCR) is a purpose-built ECT unit that is publicly funded by the State Government of New South Wales (NSW). Since the initiation of the first oncology ECT at SCR in June 2017, there has been an exponential rise in the number of trials opened and patients accrued. Here we summarise SCR’s trial activities in its first 14 months of operation.

Methods: All cancer patients reviewed at SCR from 1 June 2017 to 31 July 2018 were identified from the SCR database. Details of accrual into clinical trials were reviewed.

Results: A total of 13 trials were initiated: 9 phase Ia, 3 phase Ib and 1 Phase II. Investigational agents varied in their mechanisms of action, including targeted therapy (n=2), immune-oncology (IO) monotherapy (n=3), and IO dual-action or combination therapy (n=8). A total of 110 patients were reviewed: the majority (n=82, 74.5%) were referred from tertiary cancer centres around NSW. Sixty-eight patients were consented and enrolled: 6 (8.8%) failed screening, and 59 (86.8%) commenced trial treatment; update of patient outcomes will be presented. Seventeen (15.5%) patients declined trial participation, 10 (9.1%) were waitlisted due to lack of available slots, 6 (5.5%) had clinical deterioration during pre-screening and became ineligible, and 9 (8.2%) remained undecided.

Conclusion: There is an increasing demand for access to ECT, both from patients and treating oncologists, and as such, a need for high-quality ECT centres in Australia. As a dedicated ECT centre, SCR has opened clinical trials with novel agents and is a founding member of NECTA (NSW Early-phase Clinical Trials Alliance) which aims to create a centralised state-wide referral and pre-screening pathway to further facilitate access to clinical trials across NSW.