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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01081951
Ethics application status
Date submitted
26/02/2010
Date registered
5/03/2010

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
2009-015970-36
Secondary ID [2] 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 - 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.

Active comparator: 2 - paclitaxel iv and carboplatin iv


Treatment: Drugs: olaparib
Tablets Oral BID

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)
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)
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
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
Sex
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
4/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
162
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
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
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
Olomouc
Country [16] 0 0
Germany
State/province [16] 0 0
Essen
Country [17] 0 0
Germany
State/province [17] 0 0
Frankfurt
Country [18] 0 0
Germany
State/province [18] 0 0
Hamburg
Country [19] 0 0
Germany
State/province [19] 0 0
München
Country [20] 0 0
Germany
State/province [20] 0 0
Solingen
Country [21] 0 0
Italy
State/province [21] 0 0
Genova
Country [22] 0 0
Italy
State/province [22] 0 0
Milan
Country [23] 0 0
Italy
State/province [23] 0 0
Monza
Country [24] 0 0
Italy
State/province [24] 0 0
Torino
Country [25] 0 0
Japan
State/province [25] 0 0
Chuo-ku
Country [26] 0 0
Japan
State/province [26] 0 0
Fukuoka-shi
Country [27] 0 0
Japan
State/province [27] 0 0
Matsuyama-shi
Country [28] 0 0
Japan
State/province [28] 0 0
Morioka-shi
Country [29] 0 0
Japan
State/province [29] 0 0
Shinjuku-ku
Country [30] 0 0
Japan
State/province [30] 0 0
Yamagata-shi
Country [31] 0 0
Netherlands
State/province [31] 0 0
Amsterdam
Country [32] 0 0
Netherlands
State/province [32] 0 0
Nijmegen
Country [33] 0 0
Netherlands
State/province [33] 0 0
Rotterdam
Country [34] 0 0
Peru
State/province [34] 0 0
Lima
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Spain
State/province [36] 0 0
Valencia
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Birmingham
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01081951