Brief Title
A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
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
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.
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Difference in levels of PAR or PARP-1 before and after study treatment
Secondary Outcome
Frequency of adverse events, by description and grade
Condition
Ovarian Cancer
Intervention
Olaparib
Study Arms / Comparison Groups
Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
71
Start Date
July 19, 2016
Completion Date
December 2021
Primary Completion Date
June 2021
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Amit Oza, M.D., 416-946-2818,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02489006
Organization ID
OZM-058
Responsible Party
Sponsor
Study Sponsor
University Health Network, Toronto
Study Sponsor
Amit Oza, M.D., Principal Investigator, Princess Margaret Cancer Centre/University Health Network
Verification Date
December 2019