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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
Be older than 18 years old
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 Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
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 moreSide effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
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%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Thrombocytopenia
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%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
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%
General physical health deterioration
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%
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
~2210
Cediranib
2016
Completed Phase 3
~4030
Find a Location
Who is running the clinical trial?
University College, LondonLead Sponsor
842 Previous Clinical Trials
38,913,032 Total Patients Enrolled
8 Trials studying Ovarian Cancer
203,277 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a stroke or other serious blood clot in the past year.You have trouble swallowing pills or have a stomach problem that could make it hard for your body to absorb oral medications.You are allergic to the ingredients in cediranib or olaparib.You have severe side effects from previous cancer treatment, except for hair loss and nerve problems.You are taking certain medications that affect how olaparib works, and you need to stop taking them for 2 weeks before starting olaparib.You have a type of ovarian cancer that is not epithelial, or you have carcinosarcoma, clear cell carcinoma, or mucinous carcinomas.You have myelodysplastic syndrome or acute myeloid leukemia.You are allowed to have received bevacizumab as a first-line maintenance therapy before.You have experienced serious signs or symptoms of bowel blockage in the last 3 months.You have a weakened immune system, for example, if you have HIV and are taking antiviral medication.You have spinal cord compression unless you have already received treatment for it and have been stable for 28 days.You have had a hole or abnormal connection in your stomach or intestines in the past. If the hole was fixed by surgery and has not come back for at least 6 months, and your risk of it happening again is low, you may still be able to join the study.You have a serious bowel disease that is causing symptoms.You have a serious heart condition that is not under control.You have ongoing bleeding or a condition that causes frequent bleeding.You have had cancer in the past 5 years, except for certain types that have been treated successfully.You have another health condition that could make it risky for you to take the study drug.You are currently taking certain medications that can interact with the study drug. If you are taking these medications, you need to stop them for a specific period of time before starting the study.You have Hepatitis B or C that is currently active.You have uncontrollable symptoms from cancer that has spread to your brain or meninges. If you are taking corticosteroids for this, you must have started at least 4 weeks before the study.You have had a bone marrow transplant from someone else or a double umbilical cord blood transplant.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.Your BRCA gene mutation status must be known before you can join the study.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.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.You are in good enough health to carry out everyday activities or can carry out light work.You need to have a tissue sample from a previous surgery or a blood sample for genetic testing.Your blood pressure is well controlled with a maximum of two medications. Your systolic blood pressure is 140 or lower, and your diastolic blood pressure is 90 or lower.Your thyroid is working well and you don't have any thyroid-related symptoms.Your bone marrow is working well, and your blood counts are within the normal range. You haven't had a blood transfusion in the past 14 days.Your liver is working well, and your blood tests show normal levels of bilirubin and transaminases. If you have liver metastasis, the transaminase levels can be slightly higher.Your kidneys are working well, and you don't have too much protein in your urine.
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Olaparib
- Group 2: Olaparib and Cediranib
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