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.

EPIK-O : EPIK-O: A Phase III, Multi-center, Randomized (1:1), Open-label, Active-controlled, Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Olaparib as Compared to Single Agent Cytotoxic Chemotherapy, in Participants With no Germline BRCA Mutation Detected, Platinum-resistant or Refractory, High-grade Serous Ovarian Cancer

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Female Reproductive<br/>System CancersCancer LocationFemale Reproductive
System Cancers

Systemic therapy | Female reproductive organsOvary

Trial Overview Read MoreRead more

This phase III study is evaluating how safe and effective a combined treatment of targeted therapy (alpelisib) and a different cancer drug (olaparib), compared to chemotherapy (paclitaxel or pegylated liposomal doxorubicin), is in people with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected.
 

This trial is treating patients with ovarian cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • 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

EPIK-O: A Phase III, Multi-center, Randomized (1:1), Open-label, Active-controlled, Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Olaparib as Compared to Single Agent Cytotoxic Chemotherapy, in Participants With no Germline BRCA Mutation Detected, Platinum-resistant or Refractory, High-grade Serous Ovarian Cancer

Commercial Sponsor

Novartis Pharmaceuticals

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive Alpelisib + olaparib. Alpelisib will be administered at a dose of 200mg, orally, once daily. Olaparib will be administered at a dose of 200mg, orally, twice daily. In the Active Comparator Arm, participants will receive the investigator's choice of one of 2 single agent cytotoxic chemotherapies: Paclitaxel (80 mg/m2, intravenously, weekly) or Pegylated liposomal Doxorubicin (PLD) (40-50 mg/m2, intravenously, every 28 days).

Recruiting Hospitals Read MoreRead more

Goulburn Valley Health
Shepparton
Ms Carole Mott
oncologyclinicaltrials@gvhealth.org.au
(03) 5832 3777

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.

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