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

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.

Conditions

  • Ovarian Neoplasms
  • Ovarian Cancer

Study Type

Interventional

Study Design

Treatment, Randomised, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study.

Further Details

Primary Outcome Measures:

  • To compare the objective tumour response rate, as evaluated according to RECIST guidelines, in patients treated with AZD0530 in combination with carboplatin plus paclitaxel versus carboplatin plus paclitaxel alone
    [Time Frame: Assessed after each treatment over a period of 8 months]
    [Designated as safety issue: No]

Secondary Outcome Measures:

  • To investigate the safety and tolerability of AZD0530 in combination with carboplatin plus paclitaxel versus carboplatin plus paclitaxel alone.
    [Time Frame: Assessed after each treatment over a period of 8 months]
    [Designated as safety issue: No]
  • To compare progression-free survival in patients treated with AZD0530 in combination with carboplatin plus paclitaxel versus carboplatin plus paclitaxel alone.
    [Time Frame: Assessed after each treatment over a period of 8 months + 1 month followup]
    [Designated as safety issue: No]
  • To estimate the overall survival in patients treated with AZD0530 in combination with carboplatin plus paclitaxel versus carboplatin plus paclitaxel alone.
    [Designated as safety issue: No]

Study Start

April 2008

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and older
  • Genders Eligible for Study: Female
  • Accepts Healthy Volunteers: No

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

Total Enrolment

200

Contact Details

AstraZeneca Clinical Study Information      
AZD0530ClinicalTrialsMailbox@astrazeneca.com

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