For Healthcare Professionals

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

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Confirmed documented deleterious or suspected deleterious BRCA mutation. (The presence of a loss-of-function germline mutation in the BRCA1 and/or BRCA2 gene must be confirmed prior to consent according to local practice).
  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

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 absorption 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)

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Ovarian,Breast,Prostate,Pancreatic,Advanced Tumours

Age (in years)

18 - 130

Phase

Phase 2

Participants needed

298

Est. Completion Date

Jun 30, 2023

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT01078662

Study number

D0810C00042

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