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
Secondary Outcome Measures:
- To investigate the safety and tolerability of AZD0530 in combination with carboplatin plus paclitaxel versus carboplatin plus paclitaxel alone.
- To compare progression-free survival in patients treated with AZD0530 in combination with carboplatin plus paclitaxel versus carboplatin plus paclitaxel alone.
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
Phone: +1-800-236-9933
Email: information.center@astrazeneca.com
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