Clinical Trials

Title   AstrZeneca D8488C00001
Principal Investigator/ Physician   Rodney Rocconi, MD
Protocol┬áNo.   D8488C00001
Open Date   02/22/2018
Gender   Female
Cancer Site   Ovarian
Status   Open
Sponsor   Astra Zeneca
Contact Email   MCI Clinical Trials

Protocol Title: A single arm, open-label, Phase IIb study to assess the efficacy and safety of the combination of cediranib and olaparib tablets in women with recurrent
platinum resistant epithelial ovarian cancer, including fallopian tube and/or primary peritoneal cancer who do not carry a deleterious or suspected deleterious germline BRCA mutation

Inclusion Criteria:  Ability and willingness to provide written informed consent, and to comply with the requirements of the protocol; 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; No evidence of deleterious or suspected deleterious germline mutation in BRCA1 or BRCA2 genes; Recurrent platinum-resistant disease, defined as disease progression within 6 months (182 days) of the last receipt of platinum-based chemotherapy; 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; Eastern Cooperative Oncology Group (ECOG) performance status 0-2; Life expectancy ≥12 weeks; 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; At least three prior lines of therapy for advanced ovarian cancer as defined in the protocol; Confirmation of the availability of a tumor sample from the primary or recurrent cancer must be provided; Patients must have adequate organ and bone marrow function; Adequately controlled blood pressure; Adequately controlled thyroid function, with no symptoms of thyroid dysfunction; Able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption of cediranib or olaparib; 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: Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site); Previous enrollment in the present study; Exposure to any IP during the last 4 weeks prior to enrollment; Previous treatment with PARP inhibitor. For this study, BSI-201 (iniparib) is not considered as PARPi; 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; Cancer antigen-125 (CA-125) only disease without RECIST 1.1 measurable disease; 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; Clinically significant signs and/or symptoms of bowel obstruction within 3 months prior to starting treatment; History of intra-abdominal abscess within 3 months prior to starting treatment ;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 ;Other malignancy within the last 5 years;Persisting ≥Grade 2 CTCAE toxicity (except alopecia and Grade 2 peripheral neuropathy) from previous anti-cancer treatment(s); Central nervous system metastases; 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; 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; History of stroke or transient ischemic attack within 6 months; Uncontrolled intercurrent illness; Patients with myelodysplastic syndrome (MDS)/ treatment-related acute myeloid leukemia (t-AML) or with features suggestive of MDS/AML; No prior allogenic bone marrow transplant or double umbilical cord blood transplantation; Known active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection on antiviral treatment; Concomitant use of known strong or moderate CYP3A inhibitors; Concomitant use of known strong or moderate CYP3A inducers

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