AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer

Phase 2

Completed

• Conditions: Ovarian Neoplasms; Ovarian Cancer
• Interventions: Drug: AZD0530; Drug: Carboplatin; Drug: Paclitaxel

• Registration Number: NCT00610714
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-02-08
• Study Start: 2008-04
• Primary Completion: 2009-08
• Results First Submitted: 2011-05-03
• Results First Submitted QC: 2011-08-16
• Results First Posted: 2011-09-20
• Study Completion: 2012-01
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 211

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	AZD0530	AZD0530 in combination with carboplatin plus paclitaxel
2	Paclitaxel	AZD0530 in combination with carboplatin plus paclitaxel
Active Comparator	Paclitaxel	carboplatin plus paclitaxel
Active Comparator	Carboplatin	carboplatin plus paclitaxel
2	Carboplatin	AZD0530 in combination with carboplatin plus paclitaxel

Primary Outcome Measures

Name	Time	Method
Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)	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 Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) as Evaluated by RECIST	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.
Overall Survival (Number of Deaths)	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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Coventry, United Kingdom