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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

AZD0530 in combination with carboplatin plus paclitaxel

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

AZD0530 Phase II Study in Patients with Advanced Ovarian Cancer

Cancer Study Locator (US and Canada only)

Research Site

A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients with Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

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.

Age Continuous

Gender, Customized

Race, Customized

Body Surface Area (BSA)

Study Specific Characteristic

minimum value=0=best outcome, maximum value=4=worst outcome

World Health Organization (WHO) Performance Status

Primary Tumour Location (Number of Participants)

Tumour Grade

Objective Response Rate as evaluated by Response Evaluation Criteria In Solid Tumors ( 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.

Progression-free survival (PFS) as evaluated by RECIST

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

Overall Survival (number of deaths)

Overall Study

Following enrolment there was a 28 day screening period, after which if all inclusion/exclusion criteria were met, patients were randomized to treatment.

Arms	Assigned Interventions
Active Comparator: Active Comparator carboplatin plus paclitaxel	Drug: Carboplatin intravenous injection Other Name: CBDCA Other Name: Paraplatin® Drug: Paclitaxel intravenous infusion Other Name: Taxol®
Experimental: 2 AZD0530 in combination with carboplatin plus paclitaxel	Drug: AZD0530 oral once daily dose Drug: Carboplatin intravenous injection Other Name: CBDCA Other Name: Paraplatin® Drug: Paclitaxel intravenous infusion Other Name: Taxol®

AZD0530 Phase II Study in Patients with Advanced Ovarian Cancer - OVERT-1

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Cancer Study Locator (US and Canada only)

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=414&filename=CSR-D8180C00015.pdf

CSR-D8180C00015.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator