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Clinical Trials in Canada / NCT02489006
Active, not recruiting Phase 2

A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

NCT02489006 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2016-07-19
Last updated
2026-06-23

Condition(s) studied

Ovarian CancerFallopian Tube CancerNeoadjuvant TreatmentDebulking Surgical Procedures

Investigational drug(s) / intervention(s)

Olaparib →Platinum-based Chemotherapy

Platinum-based Chemotherapy: Chosen by the study doctor, per standard of care.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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 * 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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Tom Baker Cancer Centre Calgary Alberta
Ottawa Regional Cancer Centre Ottawa Ontario
Princess Margaret Cancer Centre Toronto Ontario
Centre hospitalier de l'Université de Montréal (CHUM Montreal Quebec
Jewish General Hospital Montreal Quebec
Auckland City Hospital Grafton Auckland
Vall d'Hebron University Hospital Barcelona Spain
Royal Marsden Hospital NHS Foundation Trust London United Kingdom
Imperial College Healthcare NHS Trust London United Kingdom

On this site

📄 Lynparza (olaparib) drug profile →

More University Health Network, Toronto trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02489006 on ClinicalTrials.gov ↗ ← All trials in Canada