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Closed (no longer recruiting)Last updated: 29 August 2023

ICON9: This phase III trial is comparing maintenance therapy with two oral drugs (Olaparib and Cediranib), versus Olaparib as a maintenance therapy alone, in patients with relapsed ovarian cancerInternational Phase III Randomised Study to Evaluate the Efficacy of Maintenance Therapy With Olaparib and Cediranib or Olaparib Alone in Patients With Relapsed Ovarian Cancer Following a Response to Platinum-based Chemotherapy

Clinical summary

Summary

In this trial, patients will be randomised into one of two arms. In the experimental arm, patients will receive oral olaparib 300mg BD and oral cediranib 20mg OD; in the comparator arm, patients will receive oral olaparib 300mg BD alone. All patients attend hospital for a 2 weekly review for the first 8 weeks, then 4 weekly for year 1 and 8 weekly for year 2 onwards until discontinuation of all trial drugs. Treatment may continue beyond progression until the next line of treatment if the patient is deemed to still be deriving clinical benefit. QOL instruments will be collected at baseline, every clinic visit and continue to be completed after relapse.

Conditions

This trial is treating patients with ovarian cancer.

Cancer

Female Reproductive System Cancers Female Reproductive System

Age

People18+

Phase

III

Trial Acronym

ICON9

More information

Trial Identifiers

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Commercial Sponsor

University College London Hospitals

Scientific Title

International Phase III Randomised Study to Evaluate the Efficacy of Maintenance Therapy With Olaparib and Cediranib or Olaparib Alone in Patients With Relapsed Ovarian Cancer Following a Response to Platinum-based Chemotherapy

Eligibility

Inclusion

  • 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.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
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