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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01081951




Registration number
NCT01081951
Ethics application status
Date submitted
26/02/2010
Date registered
5/03/2010
Date last updated
17/06/2020

Titles & IDs
Public title
Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer
Scientific title
A Phase II Open Label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients With Platinum Sensitive Advanced Serous Ovarian Cancer
Secondary ID [1] 0 0
D0810C00041
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - olaparib
Treatment: Drugs - paclitaxel
Treatment: Drugs - carboplatin
Treatment: Drugs - paclitaxel
Treatment: Drugs - Drug: carboplatin

Experimental: 1 - 200mg, 400mg BID - CAPSULES Olaparib paclitaxel iv and carboplatin iv

Active Comparator: 2 - paclitaxel iv and carboplatin iv


Treatment: Drugs: olaparib
Oral dose capsule 200mg BID day 1-10 of every 21 day cycle, Oral dose capsule 400mg BID continuously after completion of combination therapy

Treatment: Drugs: paclitaxel
175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle

Treatment: Drugs: carboplatin
AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle

Treatment: Drugs: paclitaxel
175mg/m2 iv for up to 6 cycles (18 weeks)

Treatment: Drugs: Drug: carboplatin
AUC4 iv for up to 6 cycles (18 weeks)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) - PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (=20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression).
Timepoint [1] 0 0
Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)
Secondary outcome [1] 0 0
Overall Survival (OS) - OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.
Timepoint [1] 0 0
Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months)
Secondary outcome [2] 0 0
Percentage Change in Tumour Size - The total tumour size was defined as the sum of the longest diameters of the target lesions. At week 9, the percentage change in tumour size was calculated as [(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions]*100 for each patient. Imputations were used for missing data where possible.
Timepoint [2] 0 0
Week 9 (+/- 1 week)

Eligibility
Key inclusion criteria
- Diagnosed with serous ovarian cancer

- Patients who have received no more than 3 previous platinum containing treatments and
were progression free for at least 6 months following the end of the last platinum
treatment

- At least one lesion that is suitable for accurate repeated measurements
Minimum age
18 Years
Maximum age
125 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients receiving any systemic anticancer chemotherapy, radiotherapy (except
palliative) within two weeks from the last dose prior to study treatment

- Hypersensitivity to pre medications required for treatment with paclitaxel/carboplatin

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Parkville
Recruitment hospital [2] 0 0
Research Site - Randwick
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
Belgium
State/province [6] 0 0
Brussels
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Namur
Country [9] 0 0
Belgium
State/province [9] 0 0
Wilrijk
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Czechia
State/province [13] 0 0
Brno
Country [14] 0 0
Czechia
State/province [14] 0 0
Hradec Kralove
Country [15] 0 0
Czechia
State/province [15] 0 0
Praha 2
Country [16] 0 0
Germany
State/province [16] 0 0
Frankfurt
Country [17] 0 0
Germany
State/province [17] 0 0
Hamburg
Country [18] 0 0
Germany
State/province [18] 0 0
München
Country [19] 0 0
Germany
State/province [19] 0 0
Solingen
Country [20] 0 0
Italy
State/province [20] 0 0
Genova
Country [21] 0 0
Italy
State/province [21] 0 0
Milan
Country [22] 0 0
Japan
State/province [22] 0 0
Chuo-ku
Country [23] 0 0
Japan
State/province [23] 0 0
Fukuoka-shi
Country [24] 0 0
Japan
State/province [24] 0 0
Matsuyama-shi
Country [25] 0 0
Japan
State/province [25] 0 0
Morioka-shi
Country [26] 0 0
Japan
State/province [26] 0 0
Shinjuku-ku
Country [27] 0 0
Japan
State/province [27] 0 0
Yamagata-shi
Country [28] 0 0
Japan
State/province [28] 0 0
Yonago-shi
Country [29] 0 0
Netherlands
State/province [29] 0 0
Amsterdam
Country [30] 0 0
Netherlands
State/province [30] 0 0
Nijmegen
Country [31] 0 0
Netherlands
State/province [31] 0 0
Rotterdam
Country [32] 0 0
Panama
State/province [32] 0 0
Ciudad de Panama
Country [33] 0 0
Peru
State/province [33] 0 0
Lima
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Valencia
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Birmingham
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Coventry
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Edinburgh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4)
when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian
cancer.
Trial website
https://clinicaltrials.gov/show/NCT01081951
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jane Robertson, BSc, MBCHB, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications