AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer

Study Overview
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Brief Summary
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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
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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
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Ovarian Neoplasms, Ovarian Cancer

Intervention / Treatment
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* Drug: AZD0530
* Drug: Carboplatin
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator<br>carboplatin plus paclitaxel | Drug: Carboplatin<br>* intravenous injection<br>* Other names: Paraplatin®;Drug: Paclitaxel<br>* intravenous infusion<br>* Other names: Taxol®;|
| Experimental: 2<br>AZD0530 in combination with carboplatin plus paclitaxel | Drug: AZD0530<br>* oral once daily dose<br>Drug: Carboplatin<br>* intravenous injection<br>* Other names: Paraplatin®;Drug: Paclitaxel<br>* intravenous infusion<br>* Other names: Taxol®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST) | 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 | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Tumour, Ovarian Neoplasms, Ovarian Cancer