Ovarian CancerPhase 2NEONCT02489006
A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
A Phase 2 study testing Olaparib and Platinum-based Chemotherapy in people with Ovarian Cancer and Fallopian Tube Cancer, run by University Health Network, Toronto at 9 sites in 4 countries.
Trial summary
This is a study that will look at the effects and how useful investigational drug olaparib is as a neoadjuvant treatment (treatment given as to shrink a tumor before the main treatment) prior to surgery in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Neoadjuvant Treatment
- What is being tested?
- Olaparib and Platinum-based Chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 19 Jul 2016to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven recurrent high grade serous ovarian/primary peritoneal or fallopian tube cancer.
- Patients must have disease amenable to pre-operative biopsy.
- Patients must have disease deemed suitable for surgical debulking.
- Patients must have a progression free interval of at least 6 months prior to registration.
- Patients must have had at least one line of platinum based therapy.
- Patients must have shown platinum sensitivity to their last line of platinum therapy
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- Age >=18 years
- ECOG performance status 0-1 within 7 days of registration
- Life expectancy of greater than 3 months
- Patients must have normal organ and marrow function
- Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.
- Ability to understand and the willingness to sign a written informed consent document.
- Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib.
- History of allergic reactions attributed to platinum precluding further use.
- Radiation therapy within 4 weeks of registration
- Use of any other systemic, targeted, immunotherapy, chemotherapy, or investigational agents within 4 weeks of registration
- Previously received a PARP inhibitor
- Other malignancy within the last 2 years with exceptions
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- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Concomitant use of known potent CYP3A4 inhibitors
- Concomitant use of known potent CYP3A4 inducers
- Other anti-cancer therapy including immunotherapy, hormonal therapy, biological therapy, other novel agents or investigational agents
- Persistent toxicities (CTCAE v 4.03 grade >2) caused by previous cancer therapy, excluding alopecia
- Patients with myelodysplastic syndrome/acute myeloid leukemia
- Patients with brain metastases
- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
- Patients with known active hepatitis (i.e., hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
- Pregnant or breastfeeding women
- Receipt of live attenuated vaccine within 30 days prior to enrollment
- Patients with > Grade 2 hearing impairment as per CTCAE v 4.03
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Canada5 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Centre hospitalier de l'Université de Montréal (CHUM
Montreal, Quebec, H2L 2W5
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
United Kingdom2 sites
Royal Marsden Hospital NHS Foundation Trust
London, SW3 6JJ
Imperial College Healthcare NHS Trust
London
About this study
Official title: A Phase II, Open-Label, Randomized, Multi-Centre Study, of Neoadjuvant Olaparib in Patients With Platinum Sensitive Recurrent High Grade Serous Ovarian/Primary Peritoneal or Fallopian Tube Cancer
This is a study that will look at the effects and how useful investigational drug olaparib is as a neoadjuvant treatment (treatment given as to shrink a tumor before the main treatment) prior to surgery in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer.
Read the detailed description
Olaparib belongs to a class of anti-cancer agents known as poly ADP-ribose polymerase (PARP) inhibitors. Olaparib is a new type of drug for ovarian cancer. Laboratory tests show that it may help slow the growth of ovarian cancer.
Olaparib works by blocking the PARP protein. PARP is an important protein which tries to fix damaged deoxyribonucleic acid (DNA, molecules that contain important instructions for the development of cells). Many cancers are thought to develop from damaged DNA. Research has shown that PARP inhibitors stop the PARP protein from working, and that sometimes that can cause cancer cells to stop growing or die.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Neoadjuvant Treatment, Debulking Surgical Procedures
- Being tested
- Olaparib, Platinum-based Chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Also called Lynparza
Platinum-based ChemotherapyDrug
Chosen by the study doctor, per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery | Experimental | 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. Receives: Drug: Olaparib; Drug: Platinum-based Chemotherapy |
| Olaparib Prior to Surgery and Post Surgery | Experimental | Olaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery and after surgery. Receives: Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in levels of PAR or PARP-1 before and after study treatment
Measured: 4-8 weeks
Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumor tissue
Measured: 2.5 years
Secondary outcomes (7)
Frequency of adverse events, by description and grade
Measured: 2.5 years
Response rate to olaparib in the neoadjuvant period
Measured: 6 weeks
Duration of progression free survival with olaparib in comparison to platinum based chemotherapy
Measured: 2.5 years
Levels of ctDNA compared to levels of CA125
Measured: 2.5 years
Gene expression changes in tumour tissue before and after treatment with Olaparib
Measured: 2.5 years
Secondary mutation rate in surgical tumour specimens following PARP therapy and at progression
2.5 years
Measured: 2.5 years
Changes in blood based biomarkers using ctDNA before, during and after treatment with Olaparib
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study start19 Jul 2016
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Oza, M.D., Principal investigator, Princess Margaret Cancer Centre/University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489006
- Sponsor's protocol ID
- OZM-058
- Acronym
- NEO
- Status last verified
- Jun 2026
- First submitted
- 17 Apr 2015
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Randomized, Multi-Centre Study, of Neoadjuvant Olaparib in Patients With Platinum Sensitive Recurrent High Grade Serous Ovarian/Primary Peritoneal or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT02489006
- Acronym / sponsor ID
- NEO / OZM-058
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Neoadjuvant Treatment, Debulking Surgical Procedures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 19 Jul 2016 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study that will look at the effects and how useful investigational drug olaparib is as a neoadjuvant treatment (treatment given as to shrink a tumor before the main treatment) prior to surgery in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer.
Detailed description
Olaparib belongs to a class of anti-cancer agents known as poly ADP-ribose polymerase (PARP) inhibitors. Olaparib is a new type of drug for ovarian cancer. Laboratory tests show that it may help slow the growth of ovarian cancer.
Olaparib works by blocking the PARP protein. PARP is an important protein which tries to fix damaged deoxyribonucleic acid (DNA, molecules that contain important instructions for the development of cells). Many cancers are thought to develop from damaged DNA. Research has shown that PARP inhibitors stop the PARP protein from working, and that sometimes that can cause cancer cells to stop growing or die.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery | Experimental | Drug: Olaparib, Drug: Platinum-based ChemotherapyOlaparib, 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. |
| Olaparib Prior to Surgery and Post Surgery | Experimental | Drug: OlaparibOlaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery and after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically proven recurrent high grade serous ovarian/primary peritoneal or fallopian tube cancer.
- Patients must have disease amenable to pre-operative biopsy.
- Patients must have disease deemed suitable for surgical debulking.
- Patients must have a progression free interval of at least 6 months prior to registration.
- Patients must have had at least one line of platinum based therapy.
Key exclusion criteria (20 listed)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib.
- History of allergic reactions attributed to platinum precluding further use.
- Radiation therapy within 4 weeks of registration
- Use of any other systemic, targeted, immunotherapy, chemotherapy, or investigational agents within 4 weeks of registration
- Previously received a PARP inhibitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlaparibAlso: Lynparza | Drug | Olaparib Prior to Surgery and Post Surgery, Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery |
| Platinum-based ChemotherapyChosen by the study doctor, per standard of care. | Drug | Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery |
Primary outcome
Difference in levels of PAR or PARP-1 before and after study treatment
Time frame: 4-8 weeks
Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumor tissue
Time frame: 2.5 years
7 secondary outcomes
Frequency of adverse events, by description and grade
Time frame: 2.5 years
Response rate to olaparib in the neoadjuvant period
Time frame: 6 weeks
Duration of progression free survival with olaparib in comparison to platinum based chemotherapy
Time frame: 2.5 years
Levels of ctDNA compared to levels of CA125
Time frame: 2.5 years
Gene expression changes in tumour tissue before and after treatment with Olaparib
Time frame: 2.5 years
Secondary mutation rate in surgical tumour specimens following PARP therapy and at progression
Time frame: 2.5 years
Changes in blood based biomarkers using ctDNA before, during and after treatment with Olaparib
Time frame: 2.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Oza, M.D. principal investigator
Princess Margaret Cancer Centre/University Health Network
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olaparib and Platinum-based Chemotherapy in people with Ovarian Cancer and Fallopian Tube Cancer, run by University Health Network, Toronto at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, United Kingdom, New Zealand, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in levels of PAR or PARP-1 before and after study treatment (time frame: 4-8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.