Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 13 December 2021
• Main ID: NCT03402841
• Date of registration: 03/01/2018
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients OPINION
• Scientific title: A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non-Germline BRCA Mutated Ovarian Cancer Patients Who Are in Complete or Partial Response Following Platinum Based Chemotherapy
• Date of first enrolment: January 30, 2018
• Target sample size: 279
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03402841
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland, United Kingdom

Contacts

• Name: Chris Wilks
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Female patients with histologically diagnosed relapsed HGSOC (including primary
peritoneal and / or fallopian tube cancer) or high grade endometrioid ovarian cancer

- Documented gBRCA1/2 mutation status

- Patients must have completed at least 2 previous courses of platinum containing
therapy

- Patients must have normal organ and bone marrow function measured within 28 days of
starting study treatment

- ECOG performance status 0-1 (see Appendix E)

- Patients must have a life expectancy =16 weeks

- Postmenopausal or evidence of non-childbearing status for women of childbearing
potential: negative urine or serum pregnancy test within 28 days of study treatment
and confirmed prior to treatment on day 1

- At least one lesion (measurable and/or non-measurable) that can be accurately assessed
at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and is
suitable for repeated assessment OR No evidence of disease following a complete
response to chemotherapy

- An appropriately prepared tumour sample from the cancer, of sufficient quantity and
quality (as specified in the Central Laboratory Services Manual) must be available for
future central testing of tumour genetic status

Exclusion Criteria:

- Patients receiving any systemic hormonal therapy, chemotherapy or radiotherapy (except
for palliative reasons) within 3 weeks prior to start of study treatment

- Any previous treatment with PARP inhibitor, including olaparib

- Patients with a germline BRCA mutation that is predicted to be deleterious or
suspected deleterious (known or predicted to be detrimental / lead to loss of
function)

- Other malignancy unless curatively treated with no evidence of disease for =5 years
except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer
of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial
carcinoma.

- Concomitant use of known strong CYP3A inhibitors and strong (or moderate CYP3A
inducers

- Persistent toxicities (= Grade 2 Common Terminology Criteria for Adverse Event (CTCAE)
adverse event) caused by previous cancer therapy, excluding alopecia

- Patients with myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with
features suggestive of MDS/AML

- Patients with symptomatic uncontrolled brain metastases



Age minimum: 18 Years
Age maximum: 95 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Non-Germline BRCA Mutated Ovarian Cancer

Intervention(s)

Drug: Olaparib

Primary Outcome(s)

Progression Free Survival (PFS) [Time Frame: Up to maximum of 32 months (DCO: 02 Oct 2020)]

Secondary Outcome(s)

PFS by Homologous Recombination Deficiency (HRD)/ Breast Cancer Susceptibility Gene Mutation (Mutated) (BRCAm) Status [Time Frame: Up to maximum of 32 months (DCO: 02 Oct 2020)]

Chemotherapy-free Interval (CT-FI) [Time Frame: Up to a maximum of 32 months (DCO: 02 Oct 2020)]

Percentage of Patients With a 10-point Deterioration From Baseline in TOI Score at Any Point During the Treatment Period [Time Frame: Baseline up to a maximum of 32 months (DCO: 02 Oct 2020)]

Percentage of Patients With Any Improvement From Baseline in Trial Outcome Index (TOI) Score at Any Point During the Treatment Period [Time Frame: Baseline up to a maximum of 32 months (DCO: 02 Oct 2020)]

Overall Survival (OS) [Time Frame: Up to a maximum of 32 months (DCO: 02 Oct 2020)]

Time to First Subsequent Therapy or Death (TFST) [Time Frame: Up to a maximum of 32 months (DCO: 02 Oct 2020)]

Time to Treatment Discontinuation or Death (TDT) [Time Frame: Up to a maximum of 32 months (DCO: 02 Oct 2020)]

Secondary ID(s)

D0816C00020

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Covance

Myriad Genetics, Inc.

Iqvia Pty Ltd

Parexel

Theradex

Results

• Results available: Yes
• Date Posted: 11/10/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03402841