Ovarian CancerPhase 2NCT02340611
A Study of Cediranib and Olaparib at the Time Ovarian Cancer Worsens on Olaparib
A Phase 2 study testing Olaparib and Cediranib in people with Ovarian Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Olaparib and Cediranib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof of Concept Clinical Trial of the Combination Cediranib-Olaparib at the Time of Disease Progression on Olaparib in Ovarian Cancer
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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- Olaparib, Cediranib
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Also called AZD2281, KU-0059436
Polyadenosine 5'diphosphoribose polymerase (PARP) Inhibitor
CediranibDrug
Also called AZD2171, Recentin™
Vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor that is a potent inhibitor of all three VEGF receptors (VEGFR-1, -2 and -3)
| Study group | Role | What they receive |
|---|---|---|
| Cediranib and Olaparib | Experimental | 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. Receives: Drug: Olaparib; Drug: Cediranib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients whose cancer shrinks or disappears after treatment
Measured: 2 years
Secondary outcomes (4)
Percentage of decrease in CA-125 levels after treatment
Measured: 2 years
Mutation status of genes compared to response to treatment
Measured: 2 years
Number of occurences per side effect and severity
Measured: 2 years
Assess patient reported outcomes during treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Amit Oza, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340611
- Sponsor's protocol ID
- e-Volve
- Status last verified
- Jun 2018
- First submitted
- 13 Jan 2015
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Clinical Trial of the Combination Cediranib-Olaparib at the Time of Disease Progression on Olaparib in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02340611
- Acronym / sponsor ID
- e-Volve
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cediranib and Olaparib | Experimental | Drug: Olaparib, Drug: CediranibCediranib, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlaparibAlso: AZD2281, KU-0059436Polyadenosine 5'diphosphoribose polymerase (PARP) Inhibitor | Drug | Cediranib and Olaparib |
| CediranibAlso: AZD2171, Recentin™Vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor that is a potent inhibitor of all three VEGF receptors (VEGFR-1, -2 and -3) | Drug | Cediranib and Olaparib |
Primary outcome
Percentage of patients whose cancer shrinks or disappears after treatment
Time frame: 2 years
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Oza, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olaparib and Cediranib in people with Ovarian Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients whose cancer shrinks or disappears after treatment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018.