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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00610714
First received: January 23, 2008
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer


Condition Intervention Phase
Ovarian Neoplasms
Ovarian Cancer
 Drug: AZD0530
Drug: Carboplatin
Drug: Paclitaxel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Date of randomization to death due to any cause ] [ Designated as safety issue: No ]
    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


Enrollment: 211
Study Start Date: April 2008
Study Completion Date: January 2012
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Comparator
carboplatin plus paclitaxel
 Drug: Carboplatin
intravenous injection
Other Names:
  • CBDCA
  • Paraplatin®
Drug: Paclitaxel
intravenous infusion
Other Name: Taxol®
Experimental: 2
AZD0530 in combination with carboplatin plus paclitaxel
 Drug: AZD0530
oral once daily dose
Drug: Carboplatin
intravenous injection
Other Names:
  • CBDCA
  • Paraplatin®
Drug: Paclitaxel
intravenous infusion
Other Name: Taxol®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610714

  Show 50 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Chris Poole, Prof Dept. of Oncology, University Hospital, Clifford Bridge Road, Walsgrave, Coventry
Study Director: Mireille Cantarini, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00610714     History of Changes
Other Study ID Numbers: D8180C00015, AZD0530 Study 15
Study First Received: January 23, 2008
Results First Received: May 3, 2011
Last Updated: December 14, 2012
Health Authority: Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Russia: Ministry of Health of the Russian Federation
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Cancer
Tumour
Ovarian Neoplasms
Ovarian Cancer

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
 Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 19, 2013