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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

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. 
Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). 
The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions.

To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.

Study to compare the efficacy and safety of olaparib when given in combination with carboplatin and paclitaxel, compared with carboplatin and paclitaxel in patients with advanced ovarian cancer

CTIS Number

EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle

AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle

175mg/m2 iv for up to 6 cycles (18 weeks)

Research Site

A Phase II Open label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin alone in Patients with Platinum Sensitive Advanced Serous Ovarian Cancer

PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression).

Age Continuous

Age, Customized

Gender, Male/Female

Number of prior platinum-containing treatment lines

Study Specific Characteristic

Time to disease progression on completion of the previous platinum therapy

The null hypothesis for all efficacy analyses in this study is that there is no difference in treatment effects between olaparib in combination with carboplatin/paclitaxel compared with carboplatin/paclitaxel alone.

Progression free survival (PFS)

OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.

Overall survival (OS)

The total tumour size was defined as the sum of the longest diameters of the target lesions.  At week 9, the percentage change in tumour size was calculated as [(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions]*100 for each patient. Imputations were used for missing data where possible.

FAS, but including only patients with target lesions at baseline

Percentage change in tumour size

Overall Study

Patient randomisation was stratified(using an interactive voice response [IVR]system) based on:1) number of prior platinum-containing treatment lines received(1or>1) and 2)time to disease progression following completion of the previous platinum-containing therapy(>6to<=12 months or>12 months).Six patients in the C6/P arm did not receive treatment.

Gerard Lynch

OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive. There were insufficient events to calculate median OS or perform formal statistical analysis, so the number of patients who died are shown. Subsequent analysis will be performed when data are more mature (after further survival follow-up).

Study to compare the efficacy and safety of olaparib when given in combination with carboplatin and paclitaxel, compared with carboplatin and paclitaxel in patients with advanced ovarian cancer

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

CSR-D0810C00041.pdf

Redacted Protocol

Redacted Protocol

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator