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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02340611
• Date of registration: 13/01/2015
• Prospective Registration: Yes
• Primary sponsor: University Health Network, Toronto
• Public title: A Study of Cediranib and Olaparib at the Time Ovarian Cancer Worsens on Olaparib
• Scientific title: A Proof of Concept Clinical Trial of the Combination Cediranib-Olaparib at the Time of Disease Progression on Olaparib in Ovarian Cancer
• Date of first enrolment: June 2015
• Target sample size: 4
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02340611
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Amit Oza, M.D.
• Affiliation: Princess Margaret Cancer Centre

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ovarian Cancer

Intervention(s)

Drug: Olaparib

Drug: Cediranib

Primary Outcome(s)

Percentage of patients whose cancer shrinks or disappears after treatment [Time Frame: 2 years]

Secondary Outcome(s)

Number of occurences per side effect and severity [Time Frame: 2 years]

Percentage of decrease in CA-125 levels after treatment [Time Frame: 2 years]

Mutation status of genes compared to response to treatment [Time Frame: 2 years]

Assess patient reported outcomes during treatment [Time Frame: 2 years]

Secondary ID(s)

e-Volve

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AstraZeneca