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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02489006
Recruitment Status : Active, not recruiting
First Posted : July 2, 2015
Last Update Posted : May 16, 2022
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Neoadjuvant Treatment Debulking Surgical Procedures Drug: Olaparib Drug: Platinum-based Chemotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 19, 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery

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.

Drug: Olaparib
Other Name: Lynparza

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

Experimental: Olaparib Prior to Surgery and Post Surgery
Olaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery and after surgery.
Drug: Olaparib
Other Name: Lynparza

Primary Outcome Measures :
  1. Difference in levels of PAR or PARP-1 before and after study treatment [ Time Frame: 4-8 weeks ]
  2. 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 ]

Secondary Outcome Measures :
  1. Frequency of adverse events, by description and grade [ Time Frame: 2.5 years ]
  2. Response rate to olaparib in the neoadjuvant period [ Time Frame: 6 weeks ]
  3. Duration of progression free survival with olaparib in comparison to platinum based chemotherapy [ Time Frame: 2.5 years ]
  4. Levels of ctDNA compared to levels of CA125 [ Time Frame: 2.5 years ]
  5. Gene expression changes in tumour tissue before and after treatment with Olaparib [ Time Frame: 2.5 years ]
  6. Secondary mutation rate in surgical tumour specimens following PARP therapy and at progression [ Time Frame: 2.5 years ]
    2.5 years

  7. Changes in blood based biomarkers using ctDNA before, during and after treatment with Olaparib [ Time Frame: 2.5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489006

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Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre hospitalier de l'Université de Montréal (CHUM
Montréal, Quebec, Canada, H2L 2W5
Jewish General Hospital
Montréal, Quebec, Canada, H3T 1E2
New Zealand
Auckland City Hospital
Grafton, Auckland, New Zealand
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
United Kingdom
Royal Marsden Hospital NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Imperial College Healthcare NHS Trust
London, United Kingdom
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Amit Oza, M.D. Princess Margaret Cancer Centre/University Health Network
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02489006    
Other Study ID Numbers: OZM-058
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Neoplasms by Site
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents