Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer

AstraZeneca97 enrolled

Overview

The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Neoplasms

Interventions

AZD2281DRUG

400mg Oral twice daily

Liposomal DoxorubicinDRUG

50mg/m2 Monthly Intravenous

AZD2281DRUG

200mg oral twice daily

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Advanced ovarian cancer with positive BRCA1 or BRCA2 status * Progressive or recurrent disease after platinum-based chemotherapy * Measurable disease by RECIST Exclusion Criteria: * Previous anthracycline treatment * Brain metastases * Less than 28 days since last treatment used to treat the disease * Considered a poor medical risk due to a serious uncontrolled disorder

Locations (24)

Research Site

Los Angeles, California, United States

Research Site

San Francisco, California, United States

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)

Time frame: Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)

Secondary Outcomes

Objective Response Rate (ORR)

ORR was defined according to RECIST. Complete response (CR) or partial response - (PR)- 30% decrease Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.

Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Disease Control Rate

The number of patients with confirmed CR (disappearance of all target lesions) or PR (30% decrease in the sum of the longest diameter of target lesions ) or SD ( small changes ) \>4 months, divided by the number of randomised patients

Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Overall Duration of Response

The duration of response was defined as time (months) from initial assessment of PR/CR until earliest date of objective progression or death. (Values may be underestimated as some patients had not progressed at final analysis so true duration is likely to be greater than that in database.)

Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Best Percentage Change in Tumour Size

The percentage change (reduction) from baseline in the sum of the lengths of the longest diameter (LD) of the RECIST target lesions were objectively documented, regardless of whether the patient was still taking study medication

Data from ClinicalTrials.gov

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Research Site

Boca Raton, Florida, United States

Research Site

Boston, Massachusetts, United States

Research Site

New York, New York, United States

Research Site

Houston, Texas, United States

Research Site

East Melbourne, Australia

Research Site

Melbourne, Parkville, Australia

Research Site

Randwick, Australia

Research Site

Leuven, Belgium

...and 14 more locations

Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Best Percentage Change From Baseline in CA-125 Levels

Best percentage change in cancer antigen 125 (CA-125) levels

Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Confirmed RECIST Response and/or CA-125 Response

The percentage of patients reporting a RECIST confirmed response and/or a CA-125 response (in the absence of progression). A CA-125 response was defined as a confirmed greater or equal to 50% reduction in CA-125.

Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Overall Survival (OS)

OS was defined as time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date they were known to be alive. Median OS was not calculable for olaparib groups due to an insufficient number of deaths so the percentage of participants who died are shown along with 95% confidence intervals

Time frame: At the time of the cut-off for the final analysis of overall survival (30 April 2010)

Best Quality of Life (QoL) Response for Trial Outcome Index (TOI)

Best HRQoL response using the TOI endpoint. Improvement was defined as a change from baseline of greater than or equal to +7. The TOI score ranges from 0-100.

Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)

Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9.

Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Best QoL Response for FACT-O Symptom Index (FOSI)

Best HRQoL response using the FOSI endpoint. Improvement was defined as a change from baseline of greater than or equal to +3.

Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)