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Olaparib + Cediranib for Ovarian Cancer (ICON9 Trial)
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.
- Ovarian Cancer
ICON9 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowICON9 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 154 Patients • NCT02184195ICON9 Trial Design
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Who is running the clinical trial?
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- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
- Group 1: Olaparib
- Group 2: Olaparib and Cediranib
Frequently Asked Questions
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."
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."
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."
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."
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"
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."
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."
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