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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Ovarian, Breast, Prostate, Pancreatic, Advanced Tumours

Thank you

Trial Information

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


Inclusion Criteria:



- 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).

- Confirmed malignant solid tumours for which no standard treatment exists

- 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:

- Any previous treatment with a PARP inhibitor, including olaparib

- Patients unable to swallow orally administered medication and patients with
gastrointestinal disorders likely to interfere with absorption of the study
medication

- 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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

at baseline, then in every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until progression

Safety Issue:

No

Principal Investigator

Jane Robertson, BSc, MBCHB, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D0810C00042

NCT ID:

NCT01078662

Start Date:

February 2010

Completion Date:

December 2013

Related Keywords:

  • Ovarian
  • Breast
  • Prostate
  • Pancreatic
  • Advanced Tumours
  • olaparib
  • PARP inhibitors
  • genetic BRCA1 mutation
  • BRCA2 mutation
  • solid tumour refractory

Name

Location

Research SiteAnaheim, California  
Research SiteAllentown, Pennsylvania