Ovarian NeoplasmsPhase 2OVERT-1NCT00610714
AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer
A Phase 2 study testing AZD0530, Carboplatin and Paclitaxel in people with Ovarian Neoplasms and Ovarian Cancer, run by AstraZeneca at 50 sites in 12 countries.
Trial summary
The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Ovarian Cancer
- What is being tested?
- AZD0530, Carboplatin and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 50 sitesin 12 countries
- Study dates
- Apr 2008to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of advanced ovarian cancer
- Have evidence of recurrence or disease progression at least 6 months following treatment cessation of 1st or 2nd line platinum containing therapy
- Estimated life expectancy of more than 12 weeks
Who cannot join
- Central Nervous System (CNS) metastases
- Received more than 2 prior chemotherapy regimens for ovarian cancer treatment
- Inadequate bone marrow reserve
- Inadequate liver function, renal function or low haemoglobin
- Pregnant, breastfeeding or if of child-bearing status unwilling to use an acceptable method of contraception
Trial locations and contacts
50 sites in 12 countries.
50 sites in 12 countries
France10 sites
Research Site
Avignon
Research Site
Bordeaux
Research Site
Caen
Research Site
Lyon
Research Site
Montpellier
Research Site
Nantes
Research Site
Paris, Cedex 04
Research Site
Pierre-Bénite
Research Site
Reims
Research Site
Vandœuvre-lès-Nancy
Canada8 sites
Research Site
Edmonton, Alberta
Research Site
Montreal, Quebec
Research Site
Ottawa, Ontario
Research Site
Québec, Quebec
Research Site
Sherbrooke, Quebec
Research Site
St. John's, Newfoundland and Labrador
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia
Spain5 sites
Research Site
Barcelona, Catalonia
Research Site
Córdoba, Andalusia
Research Site
Hospitalet Dellobregat(barcelo, Catalonia
Research Site
Madrid, Madrid
Research Site
Valencia, Valencia
Bulgaria4 sites
Research Site
Pleven
Research Site
Plovdiv
Research Site
Sofia
Research Site
Varna
Netherlands4 sites
Research Site
Amsterdam
Research Site
Leiden
Research Site
Nijmegen
Research Site
The Hague
Portugal4 sites
Research Site
Coimbra
Research Site
Funchal
Research Site
Lisbon
Research Site
Porto
Romania4 sites
Research Site
Alba Iulia
Research Site
Baia Mare, Maramureş
Research Site
Bucharest
Research Site
Cluj-Napoca
Russia4 sites
Research Site
Kazan'
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Saint Petersburg
Denmark3 sites
Research Site
Aalborg
Research Site
Herning
Research Site
Næstved
About this study
Official title: A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer
- Conditions
- Ovarian Neoplasms, Ovarian Cancer
- Being tested
- AZD0530, Carboplatin, Paclitaxel
- Keywords
- Cancer, Tumour, Ovarian Neoplasms, Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0530Drug
oral once daily dose
CarboplatinDrug
Also called CBDCA, Paraplatin®
intravenous injection
PaclitaxelDrug
Also called Taxol®
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | carboplatin plus paclitaxel Receives: Drug: Carboplatin; Drug: Paclitaxel |
| 2 | Experimental | AZD0530 in combination with carboplatin plus paclitaxel Receives: Drug: AZD0530; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)
Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.
Measured: Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)
Secondary outcomes (2)
Progression-free Survival (PFS) as Evaluated by RECIST
Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Analysis was based on August 31, 2009 data cut-off (78 PFS events analysis) and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg.
Measured: Date of randomization to earliest date of objective disease progression or death due to any cause (conducted when a minimum of 78 progression free survival events had occurred)
Overall Survival (Number of Deaths)
Interval between date of randomization and death due to any cause. Analysis was based on January 31, 2010 data cut-off and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg. At this time, data were still immature and median overall survival was not reached. Number of deaths is presented instead
Measured: Date of randomization to death due to any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Poole, Prof, Principal investigator, Dept. of Oncology, University Hospital, Clifford Bridge Road, Walsgrave, CoventryMireille Cantarini, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610714
- Sponsor's protocol ID
- D8180C00015
- Other IDs
- AZD0530 Study 15
- Acronym
- OVERT-1
- Status last verified
- Dec 2012
- First submitted
- 23 Jan 2008
- Last updated
- 18 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583.
PubMed 19238149
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
- ClinicalTrials.gov ID
- NCT00610714
- Acronym / sponsor ID
- OVERT-1 / D8180C00015
- Conditions
- Ovarian Neoplasms, Ovarian Cancer
- Keywords
- Cancer, Tumour, Ovarian Neoplasms, Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Posted 20 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Drug: Carboplatin, Drug: Paclitaxelcarboplatin plus paclitaxel |
| 2 | Experimental | Drug: AZD0530, Drug: Carboplatin, Drug: PaclitaxelAZD0530 in combination with carboplatin plus paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a diagnosis of advanced ovarian cancer
- Have evidence of recurrence or disease progression at least 6 months following treatment cessation of 1st or 2nd line platinum containing therapy
- Estimated life expectancy of more than 12 weeks
Key exclusion criteria (5 listed)
- Central Nervous System (CNS) metastases
- Received more than 2 prior chemotherapy regimens for ovarian cancer treatment
- Inadequate bone marrow reserve
- Inadequate liver function, renal function or low haemoglobin
- Pregnant, breastfeeding or if of child-bearing status unwilling to use an acceptable method of contraception
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 |
|---|---|---|
| AZD0530oral once daily dose | Drug | 2 |
| CarboplatinAlso: CBDCA, Paraplatin®intravenous injection | Drug | 2, Active Comparator |
| PaclitaxelAlso: Taxol®intravenous infusion | Drug | 2, Active Comparator |
Primary outcome
Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)
Time frame: Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)
Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.
2 secondary outcomes
Progression-free Survival (PFS) as Evaluated by RECIST
Time frame: Date of randomization to earliest date of objective disease progression or death due to any cause (conducted when a minimum of 78 progression free survival events had occurred)
Overall Survival (Number of Deaths)
Time frame: Date of randomization to death due to any cause
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19238149Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583.
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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.
Chris Poole, Prof principal investigator
Dept. of Oncology, University Hospital, Clifford Bridge Road, Walsgrave, Coventry
Mireille Cantarini, MD study director
AstraZeneca
50 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD0530, Carboplatin and Paclitaxel in people with Ovarian Neoplasms and Ovarian Cancer, run by AstraZeneca at 50 sites in 12 countries.
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 3 inclusion and 5 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 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in France, Canada, Spain, Bulgaria, Netherlands and 7 more countries. 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?
Yes. Results are posted in the registry (first posted 20 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST) (time frame: Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00610714, which also lists 1 linked publication.
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 18 Dec 2012.