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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02489006




Registration number
NCT02489006
Ethics application status
Date submitted
17/04/2015
Date registered
2/07/2015
Date last updated
17/01/2024

Titles & IDs
Public title
A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
Scientific 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
Secondary ID [1] 0 0
OZM-058
Universal Trial Number (UTN)
Trial acronym
NEO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Fallopian Tube Cancer 0 0
Neoadjuvant Treatment 0 0
Debulking Surgical Procedures 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Platinum-based Chemotherapy

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.

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.


Treatment: Drugs: Platinum-based Chemotherapy
Chosen by the study doctor, per standard of care.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in levels of PAR or PARP-1 before and after study treatment
Timepoint [1] 0 0
4-8 weeks
Primary outcome [2] 0 0
Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumor tissue
Timepoint [2] 0 0
2.5 years
Secondary outcome [1] 0 0
Frequency of adverse events, by description and grade
Timepoint [1] 0 0
2.5 years
Secondary outcome [2] 0 0
Response rate to olaparib in the neoadjuvant period
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Duration of progression free survival with olaparib in comparison to platinum based chemotherapy
Timepoint [3] 0 0
2.5 years
Secondary outcome [4] 0 0
Levels of ctDNA compared to levels of CA125
Timepoint [4] 0 0
2.5 years
Secondary outcome [5] 0 0
Gene expression changes in tumour tissue before and after treatment with Olaparib
Timepoint [5] 0 0
2.5 years
Secondary outcome [6] 0 0
Secondary mutation rate in surgical tumour specimens following PARP therapy and at progression
Timepoint [6] 0 0
2.5 years
Secondary outcome [7] 0 0
Changes in blood based biomarkers using ctDNA before, during and after treatment with Olaparib
Timepoint [7] 0 0
2.5 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
71
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland
Country [5] 0 0
Spain
State/province [5] 0 0
Barcelona
Country [6] 0 0
United Kingdom
State/province [6] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
University Health Network, Toronto
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02489006
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amit Oza, M.D.
Address 0 0
Princess Margaret Cancer Centre/University Health Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02489006