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Pre-Surgery Olaparib for Ovarian Cancer (NEO Trial)

Phase 2

Waitlist Available

Led By Amit Oza, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have shown platinum sensitivity to their last line of platinum therapy

Age >=18 years

Must not have

Patients with > Grade 2 hearing impairment as per CTCAE v 4.03

Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well olaparib works as a neoadjuvant treatment for ovarian, primary peritoneal, or fallopian tube cancer.

Who is the study for?

This trial is for adults with recurrent high-grade serous ovarian, primary peritoneal or fallopian tube cancer suitable for surgery. Participants must have responded to platinum therapy after a previous recurrence and be in good health otherwise. They should not have had certain treatments recently, no history of severe allergies to similar drugs, and agree to use contraception.

What is being tested?

The study tests Olaparib as an initial treatment before surgery in patients with specific types of cancer that have recurred. It aims to see how effective this drug is at shrinking tumors when given prior to the main surgical treatment.

What are the potential side effects?

Olaparib may cause side effects like nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, and potential allergic reactions. The severity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My last platinum-based treatment was effective.

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I am 18 years old or older.

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My organs and bone marrow are functioning normally.

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My cancer is a recurrent high-grade serous type in the ovary, peritoneum, or fallopian tube.

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My condition is considered operable for tumor removal.

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I have received platinum-based chemotherapy before.

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My condition allows for a biopsy before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My hearing loss is not severe.

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I do not have any serious, uncontrolled health issues or infections.

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I am not taking strong medications that affect liver enzyme CYP3A4.

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I have not had radiation therapy in the last 4 weeks.

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My cancer has spread to my brain.

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I have lasting side effects from cancer treatment, but not hair loss.

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I do not have active hepatitis B or C.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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I have been treated with a PARP inhibitor before.

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I am not taking strong medications that affect liver enzymes.

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I cannot swallow pills or have a stomach condition that affects medication absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Secondary mutation rate in surgical tumour specimens following PARP therapy and at progression

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

Hyperglycaemia

Dizziness

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

2Treatment groups

Experimental Treatment

Group I: Olaparib Prior to Surgery, Chemotherapy/Olaparib Post SurgeryExperimental Treatment2 Interventions

Olaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery. Platinum-based chemotherapy chosen by the study doctor and per standard of care after surgery. Olaparib, orally, at 300 mg twice per day, continuously, after chemotherapy.

Group II: Olaparib Prior to Surgery and Post SurgeryExperimental Treatment1 Intervention

Olaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery and after surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platinum-based Chemotherapy

2017

Completed Early Phase 1

~570

Olaparib

2007