Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

PARAGON II : The activity and tolerability of Aromatase inhibitor plus PI3KCA inhibitor or CDK4/6 inhibitor in women with hormone receptor positive recurrent/metastatic gynaecological neoplasms (PARAGON-II)

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Female reproductive organs,SarcomaEndometrium,Fallopian tube,Leiomyosarcoma,Ovary,Peritoneal,Sarcoma

Trial Overview Read MoreRead more

This phase II study is evaluating the effectiveness of hormone therapy (letrozole) when combined with targeted therapy (alpelisib or ribociclib) in post-menopausal women with advanced gynaecological cancers that are hormone-receptor positive.
 

This trial is treating patients with hormone-receptor positive endometrial cancer, endometrial stromal sarcoma, leiomyosarcoma, granulosa cell tumours, low grade epithelial cancer of the ovary, platinum resistant high-grade epithelial cancers of the ovary, fallopian tube and peritoneum,, and other gynaecological cancers.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

The activity and tolerability of Aromatase inhibitor plus PI3KCA inhibitor or CDK4/6 inhibitor in women with hormone receptor positive recurrent/metastatic gynaecological neoplasms (PARAGON-II)

Cooperative Group

Australia New Zealand Gynaecological Oncology Group (ANZGOG)

Other Non-Commercial Sponsor

University of Sydney

Summary

Eligible participants will be allocated to one of two treatment groups based on their PIK3CA mutation status. Participants in the PIK3CA mutation group will receive letrozole (2.5mg) oral tablets once daily continuously, plus alpelisib (300mg) oral tablet once daily continuously until disease progression or intolerance. Participants in the PIK3CA non-mutated wild-type/unknown group will receive letrozole (2.5mg) oral tablet once daily continuously, plus ribociclib (600mg) oral capsule once daily with a 3-week on/1-week off schedule until disease progression or intolerance. Oral letrozole will continue during the 1 week off ribociclib treatment.

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Albury
Ms Kate Oates
koates@bordermedonc.com.au
02 6064 1499

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

Next