Clinical Trial Summary

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Phase

Phase 2

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Funding Agency/Sponsor

Industrial

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Disease

Gynecologic Cancer

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Enrollment Eligibility

Inclusion Criteria:
1. Ability and willingness to provide written informed consent, and to comply with the
requirements of the protocol
2. Females aged ≥18 years with previous histologically proven diagnosis of high grade
serous, high grade endometroid or clear cell ovarian cancer, fallopian tube or primary
peritoneal carcinoma
3. No evidence of deleterious or suspected deleterious germline mutation in BRCA1 or
BRCA2 genes
4. Recurrent platinum-resistant disease, defined as disease progression within 6 months
(182 days) of the last receipt of platinum-based chemotherapy
5. CT/MRI evidence of measurable disease as per RECIST 1.1 defined as at least one
lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10
mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) and
which is suitable for accurate repeated measurements
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
7. Life expectancy ≥12 weeks
8. Prior receipt of antiangiogenic treatment, including but not limited to bevacizumab,
is optional. If used, it can be used in the first line or recurrent setting.
9. At least three prior lines of therapy for advanced ovarian cancer as defined in the
protocol
10. Confirmation of the availability of a tumor sample from the primary or recurrent
cancer must be provided
11. Patients must have adequate organ and bone marrow function
12. Adequately controlled blood pressure
13. Adequately controlled thyroid function, with no symptoms of thyroid dysfunction
14. Able to swallow and retain oral medications and without gastrointestinal illnesses
that would preclude absorption of cediranib or olaparib
15. Postmenopausal or evidence of non-childbearing status for women of childbearing
potential as confirmed by a negative urine or serum pregnancy test within 7 days prior
to start of IPs
Exclusion Criteria:
1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
staff and/or staff at the study site).
2. Previous enrollment in the present study.
3. Exposure to any IP during the last 4 weeks prior to enrollment.
4. Previous treatment with PARP inhibitor. For this study, BSI-201 (iniparib) is not
considered as PARPi
5. Recent cancer-directed therapies: Radiotherapy (RT) within 4 weeks, chemotherapy or
other systemic anti-cancer therapy within 4 weeks, or prior anti-angiogenic treatment
(e.g., bevacizumab) within 6 weeks prior to starting treatment
6. Cancer antigen-125 (CA-125) only disease without RECIST 1.1 measurable disease
7. Major surgical procedure within 2 weeks prior to starting treatment; patients must
have recovered from any effects of any major surgery and surgical wound should have
healed prior to starting treatment
8. Clinically significant signs and/or symptoms of bowel obstruction within 3 months
prior to starting treatment
9. History of intra-abdominal abscess within 3 months prior to starting treatment
10. History of GI perforation. Patients with a history of abdominal fistula will be
considered eligible if the fistula was surgically repaired, there has been no evidence
of fistula for at least 6 months prior to starting treatment, and patient is deemed to
be at low risk of recurrent fistula
11. Other malignancy within the last 5 years
12. Persisting ≥Grade 2 CTCAE toxicity (except alopecia and Grade 2 peripheral neuropathy)
from previous anti-cancer treatment(s)
13. Central nervous system metastases
14. Patients with any of the following: History of myocardial infarction within 6 months
prior to starting treatment; Unstable angina; Resting electrocardiogram (ECG) with
clinically significant abnormal findings; New York Heart Association functional
classification of III or IV
15. Left ventricular ejection fraction (LVEF) < lower limit of normal (LLN) per
institutional guidelines, or <55%, if threshold for normal not otherwise specified by
institutional guidelines, for patients with the following risk factors: Prior
treatment with anthracyclines; Prior treatment with trastuzumab; Prior central
thoracic RT, including exposure of heart to therapeutic doses of ionizing RT; History
of myocardial infarction within 6-12 months prior to start of IPs; Prior history of
other significant impaired cardiac function
16. History of stroke or transient ischemic attack within 6 months
17. Uncontrolled intercurrent illness
18. Patients with myelodysplastic syndrome (MDS)/ treatment-related acute myeloid leukemia
(t-AML) or with features suggestive of MDS/AML
19. No prior allogenic bone marrow transplant or double umbilical cord blood
transplantation
20. Known active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
on antiviral treatment
21. Concomitant use of known strong or moderate CYP3A inhibitors
22. Concomitant use of known strong or moderate CYP3A inducers

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