Antineoplastic Agents

All Drugs and Chemicals

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

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.

olaparib

Jane Robertson, BSc, MBCHB, MD

Bella Kaufman, MD

To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response

Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats

A Phase II, Open Label, Non Randomised, Non Comparative, Multicentre Study to Assess the Efficacy and Safety of Olaparib Given Orally Twice Daily in Patients With Advanced Cancers Who Have a Confirmed Genetic BRCA 1 and/or BRCA2 Mutation

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

Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).

Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).

Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.

Overall survival is defined as the duration from first dose till death. In absence of death, the time is calculated from first dose till the date subject last known to be alive.

Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose

Duration of response is calculated from the date of first documented response (complete or partial) until date of documented progression (as defined by RECIST 1.1) or death (by any cause) in the absence of disease progression.

Disease control rate is the proportion of patients with best response of complete or partial response or stable disease according to definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) till week 16.

AstraZeneca

OLAPARIB

Patients with primary cancer site = breast. Receiving olaparib 400mg BID

Breast Cancer

Patients with primary cancer site = ovary. Receiving olaparib 400mg BID

Ovarian Cancer

Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID

Pancreatic Cancer

Patients with primary cancer site = prostate. Receiving olaparib 400mg BID

Prostate Cancer

Patients with other primary cancers. Receiving olaparib 400mg BID

Other Cancers

Total

Age, Continuous

Age, Customized

Sex: Female, Male

Race/Ethnicity, Customized

Anitra Fielding

All Patients

Tumour Response Rate

Measurable disease analysis set - all treated patients having at least one measurable lesion at baseline

Objective Response Rate

Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.

Progression Free Survival

Overall Survival

Overall Survival Rate at 12 Months

Full analysis set - all treated patients who had at least one complete or partial response during the assessment period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats	NCT01078662	Ovarian Breast Prostate Pancreatic Advanced Tumour...	olaparib	18 Years - 130 Years	AstraZeneca
Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats	NCT01078662	Ovarian Breast Prostate Pancreatic Advanced Tumour...	olaparib	18 Years - 130 Years	AstraZeneca

Spots Global Cancer Trial Database for genetic brca1 mutation