A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 211
- Locations
- 1
- Primary Endpoint
- Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
2
AZD0530 in combination with carboplatin plus paclitaxel
Intervention: AZD0530 (Drug)
Active Comparator
carboplatin plus paclitaxel
Intervention: Carboplatin (Drug)
Active Comparator
carboplatin plus paclitaxel
Intervention: Paclitaxel (Drug)
2
AZD0530 in combination with carboplatin plus paclitaxel
Intervention: Carboplatin (Drug)
2
AZD0530 in combination with carboplatin plus paclitaxel
Intervention: Paclitaxel (Drug)
Outcomes
Primary Outcomes
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
- 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))
- Overall Survival (Number of Deaths)(Date of randomization to death due to any cause)