AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer (OVERT-1)

December 14, 2012 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
      • Sherbrooke, Quebec, Canada
        • Research Site
  • Denmark
      • Alborg, Denmark
        • Research Site
      • Herning, Denmark
        • Research Site
      • Naestved, Denmark
        • Research Site
  • France
      • Avignon, France
        • Research Site
      • Bordeaux Cedex, France
        • Research Site
      • Caen Cedex, France
        • Research Site
      • Lyon Cedex 08, France
        • Research Site
      • Montpellier Cedex 5, France
        • Research Site
      • Nantes, France
        • Research Site
      • Pierre Benite Cedex, France
        • Research Site
      • Reims Cedex, France
        • Research Site
      • Vandoeuvre Les Nancy, France
        • Research Site
    • Cedex 04
      • Paris, Cedex 04, France
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Den Haag, Netherlands
        • Research Site
      • Leiden, Netherlands
        • Research Site
      • Nijmegen, Netherlands
        • Research Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
  • Peru
      • Lima, Peru
        • Research Site
  • Portugal
      • Coimbra, Portugal
        • Research Site
      • Funchal, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Porto, Portugal
        • Research Site
  • Romania
      • Alba Iulia, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Cluj Napoca, Romania
        • Research Site
    • Maramures
      • Baia Mare, Maramures, Romania
        • Research Site
  • Russian Federation
      • Kazan, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Nizhniy Novgorod, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
  • Spain
    • Andalucia
      • Cordoba, Andalucia, Spain
        • Research Site
    • Cataluna
      • Barcelona, Cataluna, Spain
        • Research Site
      • Hospitalet Dellobregat(barcelo, Cataluna, Spain
        • Research Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain
        • Research Site
    • Comunidad de Madrid
      • Madrid, Comunidad de Madrid, Spain
        • Research Site
  • United Kingdom
      • Coventry, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Comparator
carboplatin plus paclitaxel
Drug: Paclitaxel
intravenous infusion
Other Names:
  • Taxol®
Drug: Carboplatin
intravenous injection
Other Names:
  • CBDCA
  • Paraplatin®
Experimental: 2
AZD0530 in combination with carboplatin plus paclitaxel
Drug: Paclitaxel
intravenous infusion
Other Names:
  • Taxol®
Drug: Carboplatin
intravenous injection
Other Names:
  • CBDCA
  • Paraplatin®
Drug: AZD0530
oral once daily dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
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
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
Date of randomization to death due to any cause

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Chris Poole, Prof, Dept. of Oncology, University Hospital, Clifford Bridge Road, Walsgrave, Coventry
  • Study Director: Mireille Cantarini, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

January 25, 2008

First Posted (Estimate)

February 8, 2008

Study Record Updates

Last Update Posted (Estimate)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 14, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8180C00015
  • AZD0530 Study 15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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