Overview

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

Status:
Active, not recruiting
Trial end date:
2022-03-31
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of the study is to assess the efficacy and safety of single-agent olaparib as a maintenance treatment in patients with relapsed High Grade Serous Ovarian Cancer (including patients with primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer who do not have known deleterious or suspected deleterious germline BRCA mutations (non-gBRCAm) and who had responded following platinum based chemotherapy
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Collaborators:
Covance
Iqvia Pty Ltd
Myriad Genetics, Inc.
Parexel
Quintiles, Inc.
Theradex
Treatments:
Olaparib
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