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PARP Inhibitor
Olaparib + Ramucirumab for Stomach or Esophageal Cancer
Phase 1 & 2
Waitlist Available
Led By Michael Cecchini
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 (Karnofsky >= 60%)
Patient must have experienced disease progression or intolerance as outlined above after treatment with 1 or more prior chemotherapies
Must not have
Patients with current signs and/or symptoms of bowel obstruction within 1 month prior to starting study drugs
Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib and ramucirumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Summary
This trial is testing olaparib + ramucirumab to treat gastric/gastroesophageal junction cancer that has spread or come back.
Who is the study for?
This trial is for adults with advanced gastric or gastroesophageal junction cancer that has spread and can't be surgically removed. Participants must have a life expectancy of at least 16 weeks, not have used certain drugs like ramucirumab or PARP inhibitors before, and should be able to take oral medications. They cannot join if they've had recent major surgery, uncontrolled medical conditions, known allergies to the study drugs, active infections including hepatitis B/C, other cancers, or are pregnant/breastfeeding.
What is being tested?
The trial is testing the combination of two drugs: Olaparib and Ramucirumab. Olaparib blocks enzymes needed for tumor cell growth while Ramucirumab helps the immune system attack cancer cells and prevents them from growing/spreading. The goal is to see if this combo works better than current treatments involving just Ramucirumab or chemotherapy.
What are the potential side effects?
Possible side effects include reactions related to immune response such as inflammation in organs; blood disorders; fatigue; digestive issues which could range from mild discomfort to more serious complications like ulcers; increased risk of infection due to weakened immunity; potential heart problems in those predisposed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or have some restrictions but can still care for myself.
Select...
My condition worsened or I couldn't tolerate treatment after trying at least one chemotherapy.
Select...
My past treatments did not include bevacizumab, ramucirumab, or PARP inhibitors.
Select...
My hemoglobin level is at least 10 g/dL without recent blood transfusions.
Select...
My cancer is a confirmed case of gastric or gastroesophageal junction adenocarcinoma.
Select...
I am 18 years old or older.
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I can take pills and don't have a stomach condition that affects medication absorption.
Select...
My cancer markers went up but scans didn't show the cancer growing.
Select...
My cancer has spread or cannot be removed by surgery.
Select...
I am postmenopausal or cannot become pregnant.
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My tests do not show signs of MDS or AML.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had signs or symptoms of a bowel blockage in the last month.
Select...
I am allergic to medications similar to olaparib or ramucirumab.
Select...
I have had a bone marrow or cord blood transplant in the past.
Select...
My EKG shows a QT interval of 470 msec or more, or I have a family history of long QT syndrome.
Select...
I cannot swallow pills or have stomach issues affecting medication absorption.
Select...
My heart condition severely limits my physical activity.
Select...
I have a bleeding or clotting disorder.
Select...
I have no active cancer except for treated skin cancer or localized cancer that has not spread.
Select...
I haven't had an open biopsy, non-healing wound, or significant injury in the last 28 days.
Select...
I haven't had cancer treatment for my stomach cancer in the last 3 weeks.
Select...
I haven't had any major abdominal issues like fistula, abscess, or perforation in the last 3 months.
Select...
I am not taking strong medication that affects liver enzymes.
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I may have signs of a blood disorder like MDS or AML.
Select...
I have had severe bleeding in my stomach or intestines in the last 3 months.
Select...
I have serious blood vessel problems.
Select...
My blood pressure is high and not well-managed.
Select...
My immune system is weakened.
Select...
I have not coughed up blood in the last month.
Select...
I have previously been treated with bevacizumab, ramucirumab, or a PARP inhibitor.
Select...
I have a history of hepatitis B or active hepatitis C.
Select...
I have a major surgery planned during the trial period.
Select...
I have brain metastases that have not been treated.
Select...
I do not have any serious infections, heart issues, or uncontrolled medical conditions.
Select...
I am currently using herbal products or alternative medicines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose limiting toxicity and maximum tolerated dose of olaparib (Phase I)
Objective response rate (Phase II)
Secondary study objectives
BROCA-HR status
Incidence of adverse events
Overall survival
+1 moreOther study objectives
BROCA HR assay
Side 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%
Aspartate aminotransferase increased
9%
Hyperglycaemia
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (olaparib, ramucirumab)Experimental Treatment2 Interventions
Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
2017
Completed Phase 3
~5050
Olaparib
2007
Completed Phase 4
~2190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,945 Total Patients Enrolled
Michael CecchiniPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials
58 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (olaparib, ramucirumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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