Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01078662
Registration number
NCT01078662
Ethics application status
Date submitted
1/03/2010
Date registered
2/03/2010
Date last updated
16/04/2024
Titles & IDs
Public title
Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2010-022278-15
Query!
Secondary ID [2]
0
0
D0810C00042
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ovarian
0
0
Query!
Breast
0
0
Query!
Prostate
0
0
Query!
Pancreatic
0
0
Query!
Advanced Tumours
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Treatment: Drugs - olaparib
Experimental: 1 - 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.
Treatment: Drugs: olaparib
Tablets Oral BID
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Tumour Response Rate
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
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
Query!
Secondary outcome [1]
0
0
Objective Response Rate
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
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
Query!
Secondary outcome [2]
0
0
Progression Free Survival
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
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
Query!
Secondary outcome [3]
0
0
Overall Survival
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
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
Query!
Secondary outcome [4]
0
0
Overall Survival Rate at 12 Months
Query!
Assessment method [4]
0
0
Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose
Query!
Timepoint [4]
0
0
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
Query!
Secondary outcome [5]
0
0
Duration of Response
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
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
Query!
Secondary outcome [6]
0
0
Disease Control Rate at Week 16
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
130
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/02/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/12/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
298
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Melbourne
Query!
Recruitment hospital [2]
0
0
Research Site - Randwick
Query!
Recruitment postcode(s) [1]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [2]
0
0
2031 - Randwick
Query!
Recruitment outside Australia
Country [1]
0
0
Germany
Query!
State/province [1]
0
0
Köln
Query!
Country [2]
0
0
Israel
Query!
State/province [2]
0
0
Haifa
Query!
Country [3]
0
0
Israel
Query!
State/province [3]
0
0
Jerusalem
Query!
Country [4]
0
0
Israel
Query!
State/province [4]
0
0
Petah Tikva
Query!
Country [5]
0
0
Spain
Query!
State/province [5]
0
0
Madrid
Query!
Country [6]
0
0
Sweden
Query!
State/province [6]
0
0
Lund
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01078662
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Jane Robertson, BSc, MBCHB, MD
Query!
Address
0
0
AstraZeneca
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01078662
Download to PDF