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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01078662
First received: March 1, 2010
Last updated: August 24, 2015
Last verified: August 2015
  Purpose

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


Condition Intervention Phase
Ovarian
Breast
Prostate
Pancreatic
Advanced Tumours
Drug: olaparib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Tumour Response Rate [ Time Frame: Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Tumour assessments are carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From onset of first occurrence of complete or partial response till documented progression or death by any cause in the absence of progression, assessed maximum up to 29 months ] [ Designated as safety issue: No ]
    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 at Week 16 [ Time Frame: Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16 ] [ Designated as safety issue: No ]
    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.


Enrollment: 318
Study Start Date: February 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
olaparib 400mg BD
Drug: olaparib
400mg (8 x 50mg capsules), oral BID until progression of the disease

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078662

Locations
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Australia
Research Site
East Melbourne, Australia
Research Site
Randwick, Australia
Germany
Research Site
Köln, Germany
Israel
Research Site
Haifa, Israel
Research Site
Jerusalem, Israel
Research Site
Petah Tikva, Israel
Research Site
Tel-Hashomer, Israel
Spain
Research Site
Barcelona, Spain
Sweden
Research Site
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Bella Kaufman, MD Chaim Sheba Medical Centre, Tel Hashomer, Israel
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01078662     History of Changes
Other Study ID Numbers: D0810C00042
Study First Received: March 1, 2010
Results First Received: January 13, 2015
Last Updated: August 24, 2015
Health Authority: United States: Food and Drug Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Israel: Ethics Commission
Israel: Ministry of Health
United States: Institutional Review Board
Germany: Ethics Commission
Germany: Ministry of Health
Spain: Ethics Committee
Spain: Ministry of Health
Sweden: Regional Ethical Review Board
Sweden: The National Board of Health and Welfare

Keywords provided by AstraZeneca:
olaparib
PARP inhibitors
genetic BRCA1 mutation
BRCA2 mutation
solid tumour refractory

ClinicalTrials.gov processed this record on August 31, 2015