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PARP Inhibitor

Olaparib + Cediranib for Ovarian Cancer (ICON9 Trial)

Phase 3
Recruiting
Research Sponsored by University College, London
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior front-line maintenance therapy with bevacizumab is permitted.
Patients must have had CT or MRI proven relapsed disease (measureable or non-measureable abnormalities supported by GCIG CA125 criteria of progression), or have had debulking surgery for first relapse.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

ICON9 Trial Summary

This trial will study whether adding cediranib to olaparib helps people with relapsed ovarian cancer live longer, and whether it has side effects.

Eligible Conditions
  • Ovarian Cancer

ICON9 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are allowed to have received bevacizumab as a first-line maintenance therapy before.
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You must have evidence of relapsed disease shown by a CT or MRI scan, or have had surgery to remove cancer that came back after initial treatment.
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Your BRCA gene mutation status must be known before you can join the study.
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Women over 18 years old with a specific type of ovarian, fallopian tube, or peritoneal cancer that has come back after initial treatment and needs further chemotherapy based on imaging or surgery results.
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If you are getting better with chemotherapy, you can join the ICON9 trial to check for certain gene mutations. If you had surgery, you must not be getting worse based on specific tests to join the trial.
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You are in good enough health to carry out everyday activities or can carry out light work.
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You need to have a tissue sample from a previous surgery or a blood sample for genetic testing.
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Your thyroid is working well and you don't have any thyroid-related symptoms.

ICON9 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival (PFS) measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) or date of death from any cause (in the absence of progression)
Secondary outcome measures
Adherence to maintenance therapy- compliance and dose reductions and interruptions
Cost effectiveness using EQ-5D-5L for economic evaluation
Overall survival (OS) measured from the date of randomisation to the date of death from any cause
+6 more

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Neuropathy peripheral
10%
Pruritus
9%
Dizziness
9%
Thrombocytopenia
9%
Aspartate aminotransferase increased
9%
Hyperglycaemia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Dysgeusia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
General physical health deterioration
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo

ICON9 Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Cediranib
2016
Completed Phase 3
~4030

Find a Location

Who is running the clinical trial?

University College, LondonLead Sponsor
831 Previous Clinical Trials
38,900,712 Total Patients Enrolled
8 Trials studying Ovarian Cancer
203,277 Patients Enrolled for Ovarian Cancer

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03278717 — Phase 3
Ovarian Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03278717 — Phase 3
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03278717 — Phase 3
Ovarian Cancer Research Study Groups: Olaparib, Olaparib and Cediranib

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can patients still join this research project?

"The information on clinicaltrials.gov does show that this trial is still looking for patients. The original posting was on 6/15/2018, and it was updated as recently as 9/26/2022. There are 7 locations recruiting 330 patients in total."

Answered by AI

Does Olaparib have any harmful side effects?

"Olaparib has received a score of 3 for safety by our team at Power. This is because it is a Phase 3 trial, meaning that there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

What is Olaparib used to treat most often?

"Olaparib is an effective medication for patients suffering from advance directives, primary peritoneal cancer, and malignant neoplasm of the ovary."

Answered by AI

How many people are signed up to test this new medication?

"That is correct. The clinicaltrials.gov website contains information revealing that this trial is actively looking for participants. This research was first posted on June 15th, 2018 and was edited September 26th, 2022. There are 330 positions available for patients across 7 different locations."

Answered by AI

With Olaparib, are there any similar drugs that have gone through clinical trials?

"As of now, there are a total of 202 clinical trials studying Olaparib. Of those, 27 have progressed to Phase 3 testing. Most of the research is based in Houston, Texas; however, this medication is being studied at 9565 different locations worldwide"

Answered by AI

Do many hospitals in Canada offer this treatment?

"Currently, there are 7 active clinical trial sites for this medication. They are situated in Toronto, Montréal, Edmonton and 4 other cities. To minimize travel burdens, patients should select the location closest to them."

Answered by AI

To your knowledge, does a study like this exist?

"Currently, there are 202 active trials for Olaparib being conducted in 59 countries and 1480 cities. The first study occurred 2005 and was sponsored by AstraZeneca. That initial Phase 1 trial involved 98 patients and completed drug approval in 2005. Since then, an additional 110 studies have been completed."

Answered by AI
~49 spots leftby Mar 2025