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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Olaparib
Cediranib
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cediranib and Olaparib

Arm Description

Cediranib, 20 mg , orally, once a day, every day. Olaparib, 150 mg or 200 mg (depending on previous treatment dose), orally, once a day, every day.

Outcomes

Primary Outcome Measures

Percentage of patients whose cancer shrinks or disappears after treatment

Secondary Outcome Measures

Percentage of decrease in CA-125 levels after treatment
Mutation status of genes compared to response to treatment
Number of occurences per side effect and severity
Assess patient reported outcomes during treatment

Full Information

First Posted
January 13, 2015
Last Updated
June 11, 2018
Sponsor
University Health Network, Toronto
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02340611
Brief Title
A Study of Cediranib and Olaparib at the Time Ovarian Cancer Worsens on Olaparib
Official Title
A Proof of Concept Clinical Trial of the Combination Cediranib-Olaparib at the Time of Disease Progression on Olaparib in Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Cediranib works by blocking (inhibiting) several specific proteins in cancer cells called the vascular endothelial growth factor (VEGF) receptors. These proteins are important in the formation of blood vessels to the tumor. It is believed that many tumors survive because the blood vessels on the tumors bring oxygen and nutrients to the cancer cells which enable them to grow. If the formation of the blood vessels is blocked, the tumor cells may die. Olaparib works by blocking protein called poly [adenosine diphosphate-ribose] polymerase (PARP). PARP is an important protein which tries to fix damaged deoxyribonucleic acid (DNA, molecules that contain important instructions for the development of cells). Many cancers are though develop from damaged DNA. By blocking PARP from fixing damaged DNA, the tumor cells may die. Adding cediranib to olaparib, and therefore blocking several different mechanisms for cancer growth, may stop tumor growth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cediranib and Olaparib
Arm Type
Experimental
Arm Description
Cediranib, 20 mg , orally, once a day, every day. Olaparib, 150 mg or 200 mg (depending on previous treatment dose), orally, once a day, every day.
Intervention Type
Drug
Intervention Name(s)
Olaparib
Other Intervention Name(s)
AZD2281, KU-0059436
Intervention Description
Polyadenosine 5'diphosphoribose polymerase (PARP) Inhibitor
Intervention Type
Drug
Intervention Name(s)
Cediranib
Other Intervention Name(s)
AZD2171, Recentin™
Intervention Description
Vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor that is a potent inhibitor of all three VEGF receptors (VEGFR-1, -2 and -3)
Primary Outcome Measure Information:
Title
Percentage of patients whose cancer shrinks or disappears after treatment
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Percentage of decrease in CA-125 levels after treatment
Time Frame
2 years
Title
Mutation status of genes compared to response to treatment
Time Frame
2 years
Title
Number of occurences per side effect and severity
Time Frame
2 years
Title
Assess patient reported outcomes during treatment
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Oza, M.D.
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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

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