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Completed

NCT Number: NCT00610714

AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer

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

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Key information

Conditions

Ovarian Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Pleven, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD0530

Drug

oral once daily dose

carboplatin

Drug

intravenous injection

Other names: CBDCA, Paraplatin®

paclitaxel

Drug

intravenous infusion

Other names: Taxol®

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: OVERT-1

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Feb 8, 2008
Registry last updated
Dec 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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