ANZGOG’s rare tumour, basket study, PARAGON-II, has officially opened to recruitment after activating its first site, Newcastle Private Hospital.

Led by Principal Investigator, Assoc Prof Chee Khoon Lee, the study plans to open at least 15 sites in ANZ, with a target of recruiting 182 participants.

The study follows on from PARAGON, an ANZGOG trial that pioneered a unique and novel clinical trial design – the ‘basket’ trial – to facilitate the recruitment of patients with rare tumours, within a single trial. PARAGON opened to recruitment in 2012, recruiting over 330 patients – the largest, rare tumour cohort in the world.

PARAGON-II Principal Investigator, A. Prof Chee Lee.

The PARAGON-II clinical trial seeks to improve outcomes for post-menopausal women with advanced (recurrent and/or metastatic) gynaecological cancers, that are hormone-receptor positive. The study aims to investigate if the combination treatments of letrozole plus alpelisib, and letrozole plus ribociclib, will lead to an increase in overall response rates, as compared to historical controls from the PARAGON trial, in HR+ advanced gynaecological cancers that are either PIK3CA-mutated or PIK3CA non-mutated.

Women may be eligible for this study if they are aged 18 or older, with advanced (recurrent and/or metastatic) gynaecological cancers, that are hormone-receptor positive. More information on eligibility can be found on the study’s ANZCTR page. Patients are encouraged to speak with their oncologist regarding their concerns including the best ways for their participation on a clinical trial.

PARAGON-II is an ANZGOG study funded by the Australian Government – Medical Research Future Fund in collaboration with the NHMRC Clinical Trials Centre, at the University of Sydney.

Planned sites:

  • Newcastle Private Hospital, NSW
  • Monash Medical Centre, VIC
  • Border Medical Oncology and Research Unit, NSW
  • Prince of Wales Hospital / Royal Hospital for Women, NSW
  • Westmead Hospital, NSW
  • Peter MacCallum Cancer Centre, VIC
  • Mater Cancer Care Centre, QLD
  • Sir Charles Gairdner Hospital, WA
  • Royal North Shore Hospital, NSW
  • Royal Brisbane and Women’s Hospital, QLD
  • St George Hospital, NSW
  • Auckland City Hospital, NZ
  • Wollongong Hospital, NSW
  • Royal Hobart Hospital, TAS
  • Canberra Hospital, ACT

Assoc Prof Chee Lee explains the PARAGON-II study in the video below:

Want to know more about ANZGOG’s clinical trials?

To find out more about ANZGOG’s clinical trials, click here.