A Study of Cediranib and Olaparib at the Time Ovarian Cancer Worsens on Olaparib

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 2 study (the second phase in testing a new drug or drug combination) to see how useful adding investigational drug cediranib to olaparib after disease progression on olaparib alone in patients with ovarian cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: AstraZeneca
• Treatments: Cediranib; Olaparib

Criteria

Inclusion Criteria:

• Age 18 years or older

• Performance status 2 or less

• Ovarian cancer, high grade serous or high grade endometrioid histology subtype

• Radiographically documented disease progression per RECIST 1.1

• Progression on olaparib therapy after an initial good response (more than 6 months)

• Patients must have adequate bone marrow, renal and hepatic function per local laboratory reference range

• Ongoing prior toxicities related to previous treatments recovered to grade 2 or less

• LVEF>50% by echocardiograms or MUGA

• Urine dipstick for proteinuria <2+

• Willing to undergo tumour biopsy pre-treatment

• Life expectancy of greater than 3 months

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Current bowel obstruction

• Known brain metastases

• Mean QTc >470 msec (with Bazett's correction) in screening ECG or history of familial long QT syndrome.

• Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• A New York Heart Association classification of III or IV requiring concurrent use of drugs or biologics with proarrhythmic potential.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib or cediranib

• Unable to swallow orally administered medication and/or gastrointestinal disorders likely to interfere with absorption of the study medication.

• Myelodysplastic syndrome/acute myeloid leukaemia

• Immuno-compromised 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.