Back to resultsAZD0530 Phase II Study in Patients With Advanced Ovarian Cancer (OVERT-1)
Primary Purpose
Ovarian Neoplasms, Ovarian Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD0530
Carboplatin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Neoplasms focused on measuring Cancer, Tumour, Ovarian Neoplasms, Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Active Comparator
2
Arm Description
carboplatin plus paclitaxel
AZD0530 in combination with carboplatin plus paclitaxel
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00610714
Brief Title
AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer
Acronym
OVERT-1
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms, Ovarian Cancer
Keywords
Cancer, Tumour, Ovarian Neoplasms, Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
211 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
carboplatin plus paclitaxel
Arm Title
2
Arm Type
Experimental
Arm Description
AZD0530 in combination with carboplatin plus paclitaxel
Intervention Type
Drug
Intervention Name(s)
AZD0530
Intervention Description
oral once daily dose
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
CBDCA, Paraplatin®
Intervention Description
intravenous injection
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol®
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)
Description
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.
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)
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) as Evaluated by RECIST
Description
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.
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)
Title
Overall Survival (Number of Deaths)
Description
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
Time Frame
Date of randomization to death due to any cause
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Poole, Prof
Organizational Affiliation
Dept. of Oncology, University Hospital, Clifford Bridge Road, Walsgrave, Coventry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mireille Cantarini, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
Facility Name
Research Site
City
Alborg
Country
Denmark
Facility Name
Research Site
City
Herning
Country
Denmark
Facility Name
Research Site
City
Naestved
Country
Denmark
Facility Name
Research Site
City
Paris
State/Province
Cedex 04
Country
France
Facility Name
Research Site
City
Avignon
Country
France
Facility Name
Research Site
City
Bordeaux Cedex
Country
France
Facility Name
Research Site
City
Caen Cedex
Country
France
Facility Name
Research Site
City
Lyon Cedex 08
Country
France
Facility Name
Research Site
City
Montpellier Cedex 5
Country
France
Facility Name
Research Site
City
Nantes
Country
France
Facility Name
Research Site
City
Pierre Benite Cedex
Country
France
Facility Name
Research Site
City
Reims Cedex
Country
France
Facility Name
Research Site
City
Vandoeuvre Les Nancy
Country
France
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Den Haag
Country
Netherlands
Facility Name
Research Site
City
Leiden
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
Country
Netherlands
Facility Name
Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
Coimbra
Country
Portugal
Facility Name
Research Site
City
Funchal
Country
Portugal
Facility Name
Research Site
City
Lisboa
Country
Portugal
Facility Name
Research Site
City
Porto
Country
Portugal
Facility Name
Research Site
City
Baia Mare
State/Province
Maramures
Country
Romania
Facility Name
Research Site
City
Alba Iulia
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Cluj Napoca
Country
Romania
Facility Name
Research Site
City
Kazan
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Cordoba
State/Province
Andalucia
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Hospitalet Dellobregat(barcelo
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Madrid
State/Province
Comunidad de Madrid
Country
Spain
Facility Name
Research Site
City
Valencia
State/Province
Comunidad Valenciana
Country
Spain
Facility Name
Research Site
City
Coventry
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19238149
Citation
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.
Results Reference
derived
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AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer
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