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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

No Placebo-Only Group

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 below

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I am fully active or have some restrictions but can still care for myself.

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My condition worsened or I couldn't tolerate treatment after trying at least one chemotherapy.

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My past treatments did not include bevacizumab, ramucirumab, or PARP inhibitors.

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My hemoglobin level is at least 10 g/dL without recent blood transfusions.

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My cancer is a confirmed case of gastric or gastroesophageal junction adenocarcinoma.

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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.

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My cancer markers went up but scans didn't show the cancer growing.

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My cancer has spread or cannot be removed by surgery.

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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:

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I have had signs or symptoms of a bowel blockage in the last month.

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I am allergic to medications similar to olaparib or ramucirumab.

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I have had a bone marrow or cord blood transplant in the past.

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My EKG shows a QT interval of 470 msec or more, or I have a family history of long QT syndrome.

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I cannot swallow pills or have stomach issues affecting medication absorption.

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My heart condition severely limits my physical activity.

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I have a bleeding or clotting disorder.

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I have no active cancer except for treated skin cancer or localized cancer that has not spread.

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I haven't had an open biopsy, non-healing wound, or significant injury in the last 28 days.

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I haven't had cancer treatment for my stomach cancer in the last 3 weeks.

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I haven't had any major abdominal issues like fistula, abscess, or perforation in the last 3 months.

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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.

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I have had severe bleeding in my stomach or intestines in the last 3 months.

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I have serious blood vessel problems.

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My blood pressure is high and not well-managed.

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My immune system is weakened.

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I have not coughed up blood in the last month.

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I have previously been treated with bevacizumab, ramucirumab, or a PARP inhibitor.

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I have a history of hepatitis B or active hepatitis C.

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I have a major surgery planned during the trial period.

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I have brain metastases that have not been treated.

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I do not have any serious infections, heart issues, or uncontrolled medical conditions.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

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 more

Other study objectives

BROCA HR assay

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195

49%

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

Dizziness

Hyperglycaemia

Aspartate aminotransferase increased

Thrombocytopenia

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Blood creatinine increased

Weight decreased

Dysgeusia

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

General physical health deterioration

Bladder papilloma

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Syncope

Incisional hernia

Device dislocation

Obstruction gastric

Cardiac failure

Vascular stenosis

Pleural effusion

Incarcerated inguinal hernia

Urinary tract infection

Hypothyroidism

Transient ischaemic attack

Infusion related reaction

Duodenal perforation

Melaena

Bile duct obstruction

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Olaparib 300 mg Twice Daily (bd)

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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