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This trial is testing the side effects and best dose of two drugs, cediranib and olaparib, compared to olaparib alone, in treating patients with recurrent ovarian, fallopian tube, peritoneal, or triple-negative breast cancer.
- Fallopian Tube Cancer
- Ovarian Cancer
- Ovarian Adenocarcinoma
- Breast Cancer
- Peritoneal Serous Adenocarcinoma
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2016 Phase 2 trial • 53 Patients • NCT01132820
Awards & Highlights
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Who is running the clinical trial?
- If you have ovarian cancer and have received chemotherapy before, your treatment must have included a platinum-based medication as the first option.You have not received a certain type of drug called a PARP-inhibitor for your cancer before, except for a specific one called BSI-201 (iniparib).You may not be eligible if you have had cancer in the past.You have certain heart-related risks or conditions.You have an ongoing and uncontrolled health condition.You are currently pregnant or breastfeeding.You cannot use natural herbal products or traditional remedies while in the study.You have been diagnosed with a specific type of cancer called epithelial ovarian cancer, primary peritoneal serous cancer, fallopian tube cancer, or triple-negative breast cancer.You have breast cancer that has come back after treatment with both Adriamycin and taxane.You have a type of ovarian, peritoneal, or fallopian tube cancer that is high-grade and has a specific genetic mutation, or you have a high-grade histology of these cancers and also carry a specific genetic mutation.You have been diagnosed with a specific type of cancer that starts in the ovaries, fallopian tubes, or lining of the abdomen.If you have ovarian cancer, primary peritoneal, or fallopian tube cancer, you must have either visible tumors or high levels of a cancer marker called CA125. These must be confirmed by two separate tests taken within three months, with at least one test taken within a week before starting treatment. If you only have high CA125 levels, you will be monitored using different criteria than if you have visible tumors.You must have a disease that can be measured using a standard method called RECIST 1.1.If you have breast cancer, your disease must be measurable according to specific criteria called RECIST.You cannot have participated in another research study or taken any experimental medications in the past 4 weeks. You also cannot have received any previous treatments that affect the VEGF pathway for your recurrent condition.You have cancer that has spread to your brain or spinal cord, and it has not been treated yet. Or, there are signs of it causing symptoms.It's okay if you have received hormone-based therapy for ovarian, primary peritoneal serous, fallopian tube cancer, or breast cancer before.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Group 1: Arm II (olaparib)
- Group 2: Arm I (cediranib maleate and olaparib)
- 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.
Frequently Asked Questions
What clinical applications is Cediranib Maleate most commonly used for?
"Cediranib Maleate is primarily prescribed for advanced directives, as well as malignant neoplasms of the ovary, primary peritoneal cancer, and hallucinations experienced by somatic individuals."
Are participants still welcome to join this clinical exploration?
"This experiment is not presently accepting new enrollees. It was first posted on March 25th, 2010 and the most recent update to the trial details occurred on November 12th of 2022. For those looking for additional tests relevant to their condition, there are 6008 studies actively recruiting participants with high grade ovarian serous adenocarcinoma and 193 trials utilizing Cediranib Maleate as an intervention that require participation."
Could you provide an overview of all the research conducted with Cediranib Maleate?
"Presently, 193 investigations into Cediranib Maleate are live with 27 in the latter phase of clinical trials. The most prolific center is located in Houston, Texas yet there are also 9498 other medical sites executing studies for this medication."
Is this a pioneering clinical trial?
"Since its Phase 1 approval in 2005, the drug Cediranib Maleate has been studied for 193 times across 59 nations and 1486 cities. This medication was first trialed by AstraZeneca with 98 participants, and since then 110 subsequent studies have taken place."
What is the uppermost limit of participants for this research endeavor?
"This clinical trial is no longer actively enrolling individuals. It was initially posted on March 25th 2010 and its latest edition occurred on November 12th 2022. Currently, there are 6008 studies recruiting patients with high grade ovarian serous adenocarcinoma and 193 trials for Cediranib Maleate that require participants."
What is the projected outcome of this research endeavor?
"This clinical trial, which will span a period of 28 days, aims to identify the Maximum Tolerated Dose (MTD) for combining cediranib and olaparib in treating recurrent ovarian cancer, fallopian tube cancer or peritoneal cancer or metastatic triple-negative breast cancere cancer or peritoneal cancer or metastatic triple-negative breast cancer. Secondary objectives include evaluating overall survival with Kaplan Meier analysis & log rank tests for between group comparison; determining treatment related toxicities from this combination via National Cancer Institute Common Terminology Criteria version 4.0; and calculating tumour response rate through Response Evaluation Criteria In Solid Tumors (RECIST)."
How many facilities are offering this trial's services?
"Currently, 14 different clinics are hosting this clinical trial. Participating cities include Fort Wayne, Boston and Charlestown as well as 11 additional sites. To minimize the burden of travel during enrollment, it is advised to select a clinic nearby your current location."
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