Olaparib in Patients With Advanced Cancers Who Have A Confirmed Genetic BRCA1 And/Or BRCA2 Mutation

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 BRCA1 And/Or BRCA2 Mutation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022278-15-SE

Enrollment

300

Registered

2010-09-27

Start date

2010-12-16

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Advanced Cancers Who Have A Confirmed Genetic BRCA1 And/Or BRCA2 Mutation MedDRA version: 14.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: PT Classification code

Interventions

Product Name: olaparib Product Code: AZD2281, KU-0059436 Pharmaceutical Form: Capsule INN or Proposed INN: olaparib CAS Number: 763113-22-0 Current Sponsor code: AZD2281 (KU-0059436) Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed BRCA1 or BRCA2 mutation 2. Confirmed malignant solid tumours for which no standard treatment exists 3. At least one lesion (measurable and/or non measurable) at baseline that can be accurately assessed by CT/MRI and is suitable for repeated assessment at follow up visits Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 260 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55

Exclusion criteria

Exclusion criteria: 1. Any previous treatment with a PARP inhibitor, including olaparib 2. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorbtion of the study medication 3. Patients receiving any systematic chemotherapy, radiotherapy (except for palliative reasons) within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is 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.;Secondary Objective: The secondary objectives of this study are: - assessment of objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR) and disease control rate (DCR) - safety and tolerability by collection of adverse events, haematology, clinical chemistry data, vital signs - Exploratory outcome measure; to enable a potential retrospective comparison of previously determined genetic BRCA mutation status taken from blood sample collection;Primary end point(s): Outcome variable(s): Efficacy ·Primary outcome variable -Tumour response (assessed using the principles of RECIST 1.1, based on confirmed response). -Safety: Adverse events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry and haematology. ;Timepoint(s) of evaluation of this end point: The analysis of all primary and secondary objectives will occur 6 months after the last patient has commenced study treatment (data cut-off).	—

Measure

Time frame

Main Objective: The primary objective of this study is 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.;Secondary Objective: The secondary objectives of this study are: - assessment of objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR) and disease control rate (DCR) - safety and tolerability by collection of adverse events, haematology, clinical chemistry data, vital signs - Exploratory outcome measure; to enable a potential retrospective comparison of previously determined genetic BRCA mutation status taken from blood sample collection;Primary end point(s): Outcome variable(s): Efficacy ·Primary outcome variable -Tumour response (assessed using the principles of RECIST 1.1, based on confirmed response). -Safety: Adverse events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry and haematology. ;Timepoint(s) of evaluation of this end point: The analysis of all primary and secondary objectives will occur 6 months after the last patient has commenced study treatment (data cut-off).

—

Secondary

Measure	Time frame
Secondary end point(s): · Secondary outcome variables - Efficacy: ORR, PFS, OS, DOR and DCR. ;Timepoint(s) of evaluation of this end point: The analysis of all primary and secondary objectives will occur 6 months after the last patient has commenced study treatment (data cut-off).	—

Countries

Australia, Germany, Israel, Spain, Sweden, United States

Contacts

Public ContactInformation Centre

AstraZeneca

informationcenter@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026