AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer
OVERT-1
A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
2 other identifiers
interventional
211
12 countries
50
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2008
Typical duration for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
February 8, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedResults Posted
Study results publicly available
September 20, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedDecember 18, 2012
December 1, 2012
1.3 years
January 23, 2008
May 3, 2011
December 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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)
Date of randomization to death due to any cause
Study Arms (2)
Active Comparator
ACTIVE COMPARATORcarboplatin plus paclitaxel
2
EXPERIMENTALAZD0530 in combination with carboplatin plus paclitaxel
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (50)
Research Site
Pleven, Bulgaria
Research Site
Plovdiv, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
Research Site
Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Aalborg, Denmark
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Herning, Denmark
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Næstved, Denmark
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Paris, Cedex 04, France
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Avignon, France
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Bordeaux, France
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Caen, France
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Lyon, France
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Montpellier, France
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Nantes, France
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Pierre-Bénite, France
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Reims, France
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Vandœuvre-lès-Nancy, France
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Amsterdam, Netherlands
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Leiden, Netherlands
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Nijmegen, Netherlands
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The Hague, Netherlands
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Bergen, Norway
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Oslo, Norway
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Lima, Lima Province, Peru
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Coimbra, Portugal
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Funchal, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Baia Mare, Maramureş, Romania
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Alba Iulia, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Kazan', Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Saint Petersburg, Russia
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Córdoba, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Hospitalet Dellobregat(barcelo, Catalonia, Spain
Research Site
Madrid, Madrid, Spain
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Valencia, Valencia, Spain
Research Site
Coventry, United Kingdom
Related Publications (1)
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.
PMID: 19238149DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Chris Poole, Prof
Dept. of Oncology, University Hospital, Clifford Bridge Road, Walsgrave, Coventry
- STUDY DIRECTOR
Mireille Cantarini, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2008
First Posted
February 8, 2008
Study Start
April 1, 2008
Primary Completion
August 1, 2009
Study Completion
January 1, 2012
Last Updated
December 18, 2012
Results First Posted
September 20, 2011
Record last verified: 2012-12