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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights
NEO Trial 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.Check my eligibility
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.See study design
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.
NEO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My last platinum-based treatment was effective.
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I am 18 years old or older.
Select...
My organs and bone marrow are functioning normally.
Select...
My cancer is a recurrent high-grade serous type in the ovary, peritoneum, or fallopian tube.
Select...
My condition is considered operable for tumor removal.
Select...
I have received platinum-based chemotherapy before.
Select...
My condition allows for a biopsy before surgery.
NEO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in levels of PAR or PARP-1 before and after study treatment
Neoplasms
Secondary outcome measures
Body Weight Changes
Pharmacotherapy
Frequency of adverse events, by description and grade
+4 moreSide 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%
Hyperglycaemia
9%
Aspartate aminotransferase increased
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
NEO 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
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,419 Total Patients Enrolled
14 Trials studying Ovarian Cancer
3,412 Patients Enrolled for Ovarian Cancer
Amit Oza, M.D.Principal InvestigatorPrincess Margaret Cancer Centre/University Health Network
10 Previous Clinical Trials
1,260 Total Patients Enrolled
4 Trials studying Ovarian Cancer
86 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hearing loss is not severe.My last platinum-based treatment was effective.I am 18 years old or older.I have been mostly active and able to carry on all pre-disease activities without restriction in the past week.My organs and bone marrow are functioning normally.I haven't had any other cancer besides this one in the last 2 years.My cancer is a recurrent high-grade serous type in the ovary, peritoneum, or fallopian tube.My condition is considered operable for tumor removal.I have received platinum-based chemotherapy before.I am willing and able to follow the study's schedule and procedures.I am not taking strong medications that affect liver enzyme CYP3A4.My condition has not worsened for at least 6 months.I haven't taken any cancer drugs or been in a study for new treatments in the last 4 weeks.I do not have any serious, uncontrolled health issues or infections.My condition allows for a biopsy before surgery.I have not had radiation therapy in the last 4 weeks.My cancer has spread to my brain.I have lasting side effects from cancer treatment, but not hair loss.I do not have active hepatitis B or C.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I have been treated with a PARP inhibitor before.I have not received a live vaccine in the last 30 days.I am not currently on any other cancer treatments like immunotherapy.I am not taking strong medications that affect liver enzymes.I cannot swallow pills or have a stomach condition that affects medication absorption.
Research Study Groups:
This trial has the following groups:- Group 1: Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery
- Group 2: Olaparib Prior to Surgery and Post Surgery
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the sample size of this research endeavor?
"This medical trial is no longer recruiting. It was posted on July 19th 2016 and last updated on May 9th 2022, so you need to look elsewhere if you are interested in taking part in a study. There are 499 studies that involve debulking surgical procedures currently open for enrollment and 349 trials related to Olaparib accepting participants."
Answered by AI
What earlier experiments utilized Olaparib in their research?
"Currently, there are 349 clinical trials that explore the effectiveness and safety of Olaparib with 87 studies in Phase 3. Phoenix, Arizona is home to most of these experiments but 30254 other sites worldwide also conduct research for this drug."
Answered by AI
How many medical centers are currently administering this experiment?
"Currently, this research project is enrolling participants from 5 different sites. These include locations within Ottawa, Montréal and Calgary as well as other regional centres. To reduce the burden of travel we suggest selecting a site near you if possible."
Answered by AI
What diseases does Olaparib commonly target?
"Olaparib is a viable option for treating advance directives, ovarian malignancies, and primary peritoneal cancer."
Answered by AI
How reliable has Olaparib been demonstrated to be for human use?
"The safety of Olaparib has been judged to be a 2 on the scale, as this is an early clinical trial with limited data regarding efficacy, but some evidence pointing towards its safety."
Answered by AI
Is there currently an enrollment process for participants of this experiment?
"According to the clinicaltrials.gov database, this medical trial is no longer recruiting candidates though it was initially posted in July 19th 2016 and last updated on May 9th 2022. However, there are 848 other studies offering participant enrolment currently."
Answered by AI
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