New hope: drug before surgery may shrink ovarian tumors
NCT ID NCT02489006
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug olaparib, given before surgery, can shrink tumors in women with recurrent ovarian cancer that has come back after at least 6 months. About 71 participants will receive either olaparib or standard chemotherapy before surgery. Researchers will measure tumor changes, side effects, and how long the cancer stays away.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Olaparib (Lynparza)
- What this could lead to
- If successful, this could show that olaparib before surgery helps shrink tumors and improves outcomes for women with recurrent ovarian cancer.
- What could go wrong
- This is a small, early-phase trial (71 participants) and results may not apply to all patients. Olaparib can cause side effects like fatigue and nausea, and the cancer may still return.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 71 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2016
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Auckland City Hospital
Grafton, Auckland, New Zealand
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Centre hospitalier de l'Université de Montréal (CHUM
Montreal, Quebec, H2L 2W5, Canada
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Imperial College Healthcare NHS Trust
London, United Kingdom
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Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
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Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
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Royal Marsden Hospital NHS Foundation Trust
London, SW3 6JJ, United Kingdom
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Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
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Vall d'Hebron University Hospital
Barcelona, 08035, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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