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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00753545




Registration number
NCT00753545
Ethics application status
Date submitted
12/09/2008
Date registered
16/09/2008

Titles & IDs
Public title
Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
Scientific title
Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens
Secondary ID [1] 0 0
2008-003439-18
Secondary ID [2] 0 0
D0810C00019
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
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - AZD2281
Treatment: Drugs - matching placebo

Experimental: 1 - AZD2281

Placebo comparator: 2 - matching placebo


Treatment: Drugs: AZD2281
Tablets Oral BID

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

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])
Timepoint [1] 0 0
Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Follow up every 12 weeks post progression, assessed maximum up to 90 months.
Secondary outcome [2] 0 0
Objective Response Rate (ORR) (According to RECIST)
Timepoint [2] 0 0
Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Secondary outcome [3] 0 0
Disease Control Rate
Timepoint [3] 0 0
Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).
Secondary outcome [4] 0 0
Duration of Response
Timepoint [4] 0 0
Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Secondary outcome [5] 0 0
Percentage Change From Baseline in Tumour Size at Week 24
Timepoint [5] 0 0
Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Secondary outcome [6] 0 0
Best Percentage Change in Cancer Antigen 125 (CA-125) Levels
Timepoint [6] 0 0
CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.
Secondary outcome [7] 0 0
Best Objective Response
Timepoint [7] 0 0
Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months.
Secondary outcome [8] 0 0
RECIST and CA-125 Response Separately and Combined
Timepoint [8] 0 0
Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.
Secondary outcome [9] 0 0
Time to Earlier of CA-125 or RECIST Progression
Timepoint [9] 0 0
Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.
Secondary outcome [10] 0 0
Improvement Rate for FACT-O Symptom Index (FOSI)
Timepoint [10] 0 0
Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Secondary outcome [11] 0 0
Improvement Rate for Trial Outcome Index (TOI)
Timepoint [11] 0 0
Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Secondary outcome [12] 0 0
Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)
Timepoint [12] 0 0
Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Secondary outcome [13] 0 0
FACT-O Symptom Index (FOSI) Time to Worsening
Timepoint [13] 0 0
Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Secondary outcome [14] 0 0
Trial Outcome Index(TOI)Time to Worsening
Timepoint [14] 0 0
Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Secondary outcome [15] 0 0
Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening
Timepoint [15] 0 0
Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.

Eligibility
Key inclusion criteria
* Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer.
* Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the penultimate chemo regimen.
* For the last chemotherapy course prior to enrolment on the study, patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained until completion of chemotherapy.
* Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen.
Minimum age
18 Years
Maximum age
130 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous treatment with PARP inhibitors including AZD2281
* Patients with low grade ovarian carcinoma.
* Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study
* Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/10/2023
Sample size
Target
Accrual to date
Final
265
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - East Bentleigh
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment hospital [3] 0 0
Research Site - Randwick
Recruitment hospital [4] 0 0
Research Site - South Brisbane
Recruitment postcode(s) [1] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
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
Indiana
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
Rhode Island
Country [5] 0 0
Austria
State/province [5] 0 0
Innsbruck
Country [6] 0 0
Austria
State/province [6] 0 0
Wein
Country [7] 0 0
Austria
State/province [7] 0 0
Wien
Country [8] 0 0
Belgium
State/province [8] 0 0
Brussels
Country [9] 0 0
Belgium
State/province [9] 0 0
Leuven
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
Olomouc
Country [15] 0 0
Czechia
State/province [15] 0 0
Praha 10
Country [16] 0 0
Estonia
State/province [16] 0 0
Tallinn
Country [17] 0 0
Estonia
State/province [17] 0 0
Tartu
Country [18] 0 0
France
State/province [18] 0 0
Bordeaux
Country [19] 0 0
France
State/province [19] 0 0
Caen Cedex
Country [20] 0 0
France
State/province [20] 0 0
Lyon Cedex 08
Country [21] 0 0
France
State/province [21] 0 0
Nantes
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
France
State/province [23] 0 0
Reims Cedex
Country [24] 0 0
Germany
State/province [24] 0 0
Essen
Country [25] 0 0
Germany
State/province [25] 0 0
Freiburg
Country [26] 0 0
Germany
State/province [26] 0 0
Göttingen
Country [27] 0 0
Germany
State/province [27] 0 0
Hannover
Country [28] 0 0
Germany
State/province [28] 0 0
Kiel
Country [29] 0 0
Germany
State/province [29] 0 0
Marburg
Country [30] 0 0
Germany
State/province [30] 0 0
München
Country [31] 0 0
Germany
State/province [31] 0 0
Ulm
Country [32] 0 0
Germany
State/province [32] 0 0
Wiesbaden
Country [33] 0 0
Israel
State/province [33] 0 0
Jerusalem
Country [34] 0 0
Israel
State/province [34] 0 0
Ramat Gan
Country [35] 0 0
Israel
State/province [35] 0 0
Tel-Aviv
Country [36] 0 0
Israel
State/province [36] 0 0
Zerifin
Country [37] 0 0
Netherlands
State/province [37] 0 0
Amsterdam
Country [38] 0 0
Poland
State/province [38] 0 0
Grzepnica
Country [39] 0 0
Poland
State/province [39] 0 0
Lublin
Country [40] 0 0
Poland
State/province [40] 0 0
Poznan
Country [41] 0 0
Poland
State/province [41] 0 0
Warszawa
Country [42] 0 0
Romania
State/province [42] 0 0
Cluj-Napoca
Country [43] 0 0
Romania
State/province [43] 0 0
Iasi
Country [44] 0 0
Romania
State/province [44] 0 0
Suceava
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Barnaul
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Ekaterinburg
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Obninsk
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Orenburg
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Perm
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Pyatigorsk
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Saint-Petersburg
Country [52] 0 0
Russian Federation
State/province [52] 0 0
St. Petersburg
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Voronezh
Country [54] 0 0
Spain
State/province [54] 0 0
Córdoba
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Valencia
Country [57] 0 0
Ukraine
State/province [57] 0 0
Donetsk
Country [58] 0 0
Ukraine
State/province [58] 0 0
Kyiv
Country [59] 0 0
Ukraine
State/province [59] 0 0
Ternopil
Country [60] 0 0
Ukraine
State/province [60] 0 0
Uzhhorod
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Edinburgh
Country [62] 0 0
United Kingdom
State/province [62] 0 0
London
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Manchester
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Sutton
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Wirral

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
Mika Sovak, 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/NCT00753545