Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000159257
Ethics application status
Approved
Date submitted
19/03/2009
Date registered
26/03/2009
Date last updated
26/03/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of Efficacy of AZD2281 in Platinum Sensitive 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 Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Platinum Sensitive Serous Ovarian Cancer 4429 0
Condition category
Condition code
Cancer 4696 4696 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
AZD2281 or Olaparib is a potent inhibitor of polyadenosine 5’-diphosphoribose
polymerase (PARP) that is being developed as an oral treatment for patients with BRCA (Breast Cancer Gene Type) related cancer. The molecular targeting of olaparib to specific subsets of tumours may
provide an opportunity for less toxic cancer monotherapy and adjuvant therapy, compared with currently available regimen. In this study, AZD2281 will be given orally 400mg twice daily. Participants will be receiving AZD2281 till their tumour assessment (via imaging scans) show disease progression according to the protocol. They can chose to stop participating in the study and hence stop receiving the drug. Their doctors or the sponsor may also stop them from receiving the study drug if it was discovered that patient is at risk, non-compliant, or for other reasons.
Intervention code [1] 4173 0
Treatment: Drugs
Comparator / control treatment
Matching placebo capsule (sugar capsule with no active drug) which looks like the study drug. Participants will be given orally and twice daily. Participants will be receiving this till their tumour assessment (via imaging scans) show disease progression according to the protocol. They can chose to stop participating in the study and hence stop receiving the drug. Their doctors or the sponsor may also stop them from receiving the study drug if it was discovered that patient is at risk, non-compliant, or for other reasons.
Control group
Placebo

Outcomes
Primary outcome [1] 5562 0
The primary objective of this study is to determine the efficacy (assessed by progression free survival [PFS]) of AZD2281 compared to placebo in this patient population. Progression free survival is defined as the time from randomisation (when the patient starts taking the study drug on Day 1 of study) to the earlier date of objective assessment of progression (per Response Evaluation Criteria in Solid Tumours [RECIST] criteria determined via evaluations of tumours using imaging scans) or death (by any cause in the absence of progression).
Timepoint [1] 5562 0
CA-125 measurements will be performed every 28 days till the patient stops taking the study drug. Radiological tumour assessments will be performed every 12 weeks for 1st 60 weeks patient is in the study and then every 24 weeks there-after till the patient has disease progression.
Secondary outcome [1] 9371 0
One of the secondary objectives of this study is to determine the efficacy of AZD2281 compared to placebo by assessment of best overall response.
Timepoint [1] 9371 0
Best overall response will be determined by Response Evaluation Criteria in Solid Tumours [RECIST] criteria determined via evaluations of tumours using imaging scans. Radiological tumour assessments will be performed every 12 weeks for 1st 60 weeks patient is in the study and then every 24 weeks there-after till the patient has disease progression.
Secondary outcome [2] 241564 0
One of the secondary objectives of this study is to determine the safety and tolerability of AZD2281 compared to placebo. Safety and tolerability will be determined via evaluation of adverse events, physical examination, vital signs, laboratory findings and so on during study visits.
Timepoint [2] 241564 0
Patients will be evaluated for safety and tolerability at weekly study visits for the first 2 months and at monthly study visits there-after. The patients will come for monthly visits till they discontinue from the study. Patients will also have a follow-up visit 30 days after they discontinue from study.

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 previous 2 chemo regimens.
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
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous treatment with polyadenosine 5’-diphosphoribose polymerase (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?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1535 0
3084
Recruitment postcode(s) [2] 1537 0
4101
Recruitment postcode(s) [3] 1536 0
4560
Recruitment postcode(s) [4] 1532 0
5000
Recruitment postcode(s) [5] 1533 0
5065
Recruitment postcode(s) [6] 1534 0
NSW 2031
Recruitment outside Australia
Country [1] 1647 0
United Kingdom
State/province [1] 1647 0
Country [2] 1648 0
Belgium
State/province [2] 1648 0
Brussel, Leuven
Country [3] 1649 0
Germany
State/province [3] 1649 0
Wiesbaden, Kiel, Marburg, Ulm, G?ttingen, Essen
Country [4] 1650 0
Israel
State/province [4] 1650 0
Tel-Aviv, Jerusalem, Tel-Hashomer, Nahariya, Zerifin
Country [5] 1651 0
Poland
State/province [5] 1651 0
Szczecin, Lublin, Poznan,
Country [6] 1652 0
Romania
State/province [6] 1652 0
Iasi, Suceava, Baia Mare, Cluj-Napoca,
Country [7] 1653 0
Ukraine
State/province [7] 1653 0
Country [8] 1654 0
United States of America
State/province [8] 1654 0
Country [9] 1655 0
Czech Republic
State/province [9] 1655 0

Funding & Sponsors
Funding source category [1] 4618 0
Commercial sector/Industry
Name [1] 4618 0
AstraZeneca
Country [1] 4618 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Astra Zeneca
Address
AstraZeneca
SE1 K/1, Parklands
Alderley Park, Macclesfield,
Cheshire
England
SK10 4TG
Country
United Kingdom
Secondary sponsor category [1] 4164 0
None
Name [1] 4164 0
Address [1] 4164 0
Country [1] 4164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6661 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [1] 6661 0
Ethics committee country [1] 6661 0
Australia
Date submitted for ethics approval [1] 6661 0
26/09/2008
Approval date [1] 6661 0
14/01/2009
Ethics approval number [1] 6661 0
EC00414

Summary
Brief summary
The primary purpose of the study is to determine the efficacy of the study drug AZD2281 compared to placebo by looking at progression free survival of the patients. Progression will be determined by tumour assessments and evaluations and patients will have regular imaging scans. The study hypotheses that AZD2281 given after an objective stable maintained response on completion of platinum containing chemotherapy improves progression free survival compared to placebo in platinum sensitive serous advanced ovarian cancer patients who have previously received two or platinum containing regimens.
Trial website
Trial related presentations / publications
Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81.
Public notes

Contacts
Principal investigator
Name 29358 0
Address 29358 0
Country 29358 0
Phone 29358 0
Fax 29358 0
Email 29358 0
Contact person for public queries
Name 12605 0
Ian Kearns
Address 12605 0
AstraZeneca R&D Charnwood
AZD2281
Study Delivery, Bakewell Road, Loughborough, Leics LE11 5RH, England
Country 12605 0
United Kingdom
Phone 12605 0
+44 (0)1509 644642
Fax 12605 0
Email 12605 0
ian.kearns@astrazeneca.com
Contact person for scientific queries
Name 3533 0
Ian Kearns
Address 3533 0
AstraZeneca R&D Charnwood
AZD2281
Study Delivery, Bakewell Road, Loughborough, Leics LE11 5RH, England
Country 3533 0
United Kingdom
Phone 3533 0
+44 (0)1509 644642
Fax 3533 0
Email 3533 0
ian.kearns@astrazeneca.com

No information has been provided regarding IPD availability


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No Supporting Document Provided


Results publications and other study-related documents

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