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Olaparib + Ramucirumab for Stomach or Esophageal Cancer
Study Summary
This trial is testing olaparib + ramucirumab to treat gastric/gastroesophageal junction cancer that has spread or come back.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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 • NCT02184195Trial Design
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Who is running the clinical trial?
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- I have had signs or symptoms of a bowel blockage in the last month.I am allergic to medications similar to olaparib or ramucirumab.I have had a bone marrow or cord blood transplant in the past.I have agreed to participate in genetic research.My EKG shows a QT interval of 470 msec or more, or I have a family history of long QT syndrome.I cannot swallow pills or have stomach issues affecting medication absorption.My heart condition severely limits my physical activity.I haven't had a severe high blood pressure crisis or brain issues from high blood pressure in the last 3 years.I have a bleeding or clotting disorder.I am fully active or have some restrictions but can still care for myself.I have no active cancer except for treated skin cancer or localized cancer that has not spread.My condition worsened or I couldn't tolerate treatment after trying at least one chemotherapy.My past treatments did not include bevacizumab, ramucirumab, or PARP inhibitors.My hemoglobin level is at least 10 g/dL without recent blood transfusions.I have agreed to let my samples be used for research.My cancer is a confirmed case of gastric or gastroesophageal junction adenocarcinoma.My cancer worsened during or soon after my last chemotherapy.I am 18 years old or older.I have not had a blood transfusion in the last 4 months.I can take pills and don't have a stomach condition that affects medication absorption.My blood pressure is below 140/90, measured by a doctor recently.My liver function tests are within normal limits, or slightly elevated if I have liver metastases.I haven't had an open biopsy, non-healing wound, or significant injury in the last 28 days.I haven't had cancer treatment for my stomach cancer in the last 3 weeks.I haven't had any major abdominal issues like fistula, abscess, or perforation in the last 3 months.I am not taking strong medication that affects liver enzymes.My cancer markers went up but scans didn't show the cancer growing.I may have signs of a blood disorder like MDS or AML.I have not had major surgery in the last 28 days.My cancer has spread or cannot be removed by surgery.I am postmenopausal or cannot become pregnant.I have had severe bleeding in my stomach or intestines in the last 3 months.I have serious blood vessel problems.My blood pressure is high and not well-managed.I have not had a clot in my arteries in the last 6 months.My immune system is weakened.I have not coughed up blood in the last month.My tests do not show signs of MDS or AML.I have previously been treated with bevacizumab, ramucirumab, or a PARP inhibitor.I have a history of hepatitis B or active hepatitis C.I have a major surgery planned during the trial period.My heart's pumping ability is within the normal range.I have brain metastases that have not been treated.I still have side effects from previous cancer treatments.I do not have any serious infections, heart issues, or uncontrolled medical conditions.I am currently using herbal products or alternative medicines.
- Group 1: Treatment (olaparib, ramucirumab)
- 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.
Frequently Asked Questions
Have other patients undergone this type of treatment before?
"Since its initial 2005 study, sponsored by AstraZeneca, Olaparib has been the focus of 247 active trials in 1671 cities and 59 countries."
What are the goals that this research is looking to achieve?
"The aim of this clinical trial is to assess the Objective response rate (Phase II) over a 14-day period. Secondary outcomes that will be evaluated include Overall survival, BROCA-HR status, and Progression free survival. These metrics will be compared using Kaplan-Meier estimates and log-rank tests, with Rothman CI values reported. Additionally, possible risk factors for each outcome will be investigated using log-rank tests. For multivariate analysis of Progression free survival data, the proportional hazards Cox modelwill be applied to investigate potential prognostic factors such as age and stage of disease. The adjusted p-values"
What health conditions does Olaparib help to treat?
"Olaparib is a medication that is used to treat cancer. It can be taken to help with adenocarcinoma, primary peritoneal cancer, and somatic conditions."
Is there still room for new participants in this experiment?
"The trial in question is not currently looking for patients, as per the clinicaltrials.gov website. This particular study was first posted on November 7th, 2017 and was last updated August 9th, 2022. There are 4,764 other trials that are actively recruiting at this time."
Are there any precedents for Olaparib's use in a clinical setting?
"Olaparib is being studied in 247 different clinical trials, with the majority of these studies (35) currently in Phase 3. The global spread of research for Olaparib includes 12821 locations, though most trial sites are located in Fargo, North dakota."
How many people have been chosen to participate in this experiment?
"This study is not currently looking for new enrollees, as the last update was on August 9th, 2022. Adenocarcinoma trials are more active, with 4517 studies recruiting patients. If you're specifically interested in Olaparib clinical trials, there are 247 different studies enrolling participants."
Could you inform me as to how many facilities are participating in this research project?
"Smilow Cancer Hospital Care Center-Fairfield in Fairfield, Connecticut, Smilow Cancer Hospital Care Center - Guiford in Guilford, Pennsylvania, University of Pittsburgh Cancer Institute (UPCI) in Pittsburgh, and 28 other hospitals are participating in this clinical trial."
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