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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

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.

Dose-finding study comparing efficacy and safety of a PARP inhibitor against Doxil in BRCA+ve advanced ovarian cancer

NCT ID

Patient Level Data

Therapeutic Area

Cancer Study Locator (US and Canada only)

Research Site

A Phase II, Open-Label, Randomised, Comparative, International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer who have failed previous platinum-based chemotherapy

Age Continuous

Sex: Female, Male

BRCA status

Study Specific Characteristic

Race/Ethnicity, Customized

The AEs reported include all events up to the OS data cut-off.  After the PFS data cut-off, AEs were only collected for the olaparib and cross-over groups.  The safety profile of these 2 groups at OS was consistent with that at the time of PFS.

Number of patients that progressed

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)

Analysis of olaparib 200 or 400 mg bd (n=64) versus liposomal doxorubicin (n=33). A hazard ratio < 1 favours olaparib.

Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio < 1 favours olaparib.

Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio < 1 favours olaparib.

Progression free survival (PFS)

Complete response

Number of Partial responders

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.

Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).

Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).

Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).

Objective response rate (ORR)

Number of Participants

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

Disease control rate

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.)

Duration of response is analysed for patients experiencing a response.

Overall duration of response

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

Best percentage change in tumour size

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

Best percentage change from baseline in CA-125 levels

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.

Confirmed RECIST response and/or CA-125 response

Number (%) of deaths

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

Overall survival (OS)

Improved

No change

Worsened

Non-evaluable

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.

Best quality of life (QoL) response for Trial Outcome Index (TOI)

No Change

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

Best QoL response for total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)

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

Best QoL response for FACT-O symptom index (FOSI)

Median PFS (95% CI)

Randomised part

Ongoing Initial Study Treatment at DCO

97 of 125 screened women with advanced BRCA 1/2 ovarian cancer who had chemotherapy were randomized

Arms	Assigned Interventions
Experimental: 1 AZD2281 Oral 200 mg BID	Drug: AZD2281 200mg oral twice daily
Active Comparator: 2 Liposomal Doxorubicin	Drug: Liposomal Doxorubicin 50mg/m2 Monthly Intravenous Other Name: Doxil®
Experimental: 3 AZD2281 Oral 400 mg BID	Drug: AZD2281 400mg Oral twice daily Other Name: Olaparib

Dose-finding study comparing efficacy and safety of a PARP inhibitor against Doxil in BRCA+ve advanced ovarian cancer - ICEBERG 3

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)

CSR_Synopsis_D0810C00012.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator