Olaparib + Cediranib for Ovarian Cancer
(ICON9 Trial)

Recruiting in Palo Alto (17 mi)

+52 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University College, London

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing two treatments for women with certain types of relapsed cancer who responded well to chemotherapy. One treatment uses two drugs to attack the cancer in different ways, while the other uses just one drug.

Research Team

Eligibility Criteria

Inclusion Criteria

You are allowed to have received bevacizumab as a first-line maintenance therapy before.

Patients should have a life expectancy ≥ 16 weeks.

Provision of informed consent prior to any study specific procedures and the ability to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations.

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Exclusion Criteria

Major surgery within 14 days before anticipated start of treatment and patients must have recovered from any effects of major surgery.

Inability to attend or comply with treatment or follow-up scheduling.

You have had a stroke or other serious blood clot in the past year.

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Treatment Details

Interventions

Cediranib (Tyrosine Kinase Inhibitor)
Olaparib (PARP Inhibitor)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Olaparib and CediranibExperimental Treatment2 Interventions

Patients will receive oral olaparib 300mg BD and oral cediranib 20mg OD. Patients will 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.

Group II: OlaparibActive Control1 Intervention

Patients will receive oral olaparib 300mg BD. Patients will 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.