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

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ClinicalTrials.gov Identifier: NCT02340611
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE January 13, 2015
First Posted Date  ICMJE January 16, 2015
Last Update Posted Date June 12, 2018
Study Start Date  ICMJE June 2015
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
Percentage of patients whose cancer shrinks or disappears after treatment [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
  • 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 ]
  • Number of occurences per side effect and severity [ Time Frame: 2 years ]
  • Assess patient reported outcomes during treatment [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Cediranib and Olaparib at the Time Ovarian Cancer Worsens on Olaparib
Official Title  ICMJE A Proof of Concept Clinical Trial of the Combination Cediranib-Olaparib at the Time of Disease Progression on Olaparib in Ovarian Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: Olaparib
    Polyadenosine 5'diphosphoribose polymerase (PARP) Inhibitor
    Other Names:
    • AZD2281
    • KU-0059436
  • Drug: Cediranib
    Vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor that is a potent inhibitor of all three VEGF receptors (VEGFR-1, -2 and -3)
    Other Names:
    • AZD2171
    • Recentin™
Study Arms  ICMJE Experimental: Cediranib and Olaparib
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.
Interventions:
  • Drug: Olaparib
  • Drug: Cediranib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2017)
4
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2015)
5
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02340611
Other Study ID Numbers  ICMJE e-Volve
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Amit Oza, M.D. Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP