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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Olaparib Drug: Cediranib Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Olaparib

Arms and Interventions
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Arm Intervention/treatment
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.
 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™


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients whose cancer shrinks or disappears after treatment [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Percentage of decrease in CA-125 levels after treatment [ Time Frame: 2 years ]
  2. Mutation status of genes compared to response to treatment [ Time Frame: 2 years ]
  3. Number of occurences per side effect and severity [ Time Frame: 2 years ]
  4. Assess patient reported outcomes during treatment [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340611


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
AstraZeneca
Investigators
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Principal Investigator: Amit Oza, M.D. Princess Margaret Cancer Centre
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02340611    
Other Study ID Numbers: e-Volve
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
 Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Olaparib
Cediranib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors