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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00753545
Registration number
NCT00753545
Ethics application status
Date submitted
12/09/2008
Date registered
16/09/2008
Date last updated
21/03/2024
Titles & IDs
Public title
Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
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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
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Secondary ID [1]
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2008-003439-18
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Secondary ID [2]
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D0810C00019
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Inflammatory and Immune System
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0
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Allergies
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Intervention/exposure
Study type
Interventional(has expanded access)
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])
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Assessment method [1]
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PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. [Full analysis set (FAS)]
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Timepoint [1]
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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.
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive.
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Timepoint [1]
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Follow up every 12 weeks post progression, assessed maximum up to 90 months.
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Secondary outcome [2]
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Objective Response Rate (ORR) (According to RECIST)
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Assessment method [2]
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For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set
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Timepoint [2]
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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.
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Secondary outcome [3]
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Disease Control Rate
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Assessment method [3]
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Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. [FAS]
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Timepoint [3]
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Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).
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Secondary outcome [4]
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Duration of Response
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Assessment method [4]
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Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. [Responding patients only]. There were insufficient responses to enable conclusions to be drawn.
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Timepoint [4]
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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.
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Secondary outcome [5]
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Percentage Change From Baseline in Tumour Size at Week 24
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Assessment method [5]
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Percentage change from baseline to Week 24 in target tumour size.
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Timepoint [5]
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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.
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Secondary outcome [6]
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Best Percentage Change in Cancer Antigen 125 (CA-125) Levels
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Assessment method [6]
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Best percentage change from baseline in CA-125 level
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Timepoint [6]
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CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.
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Secondary outcome [7]
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Best Objective Response
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Assessment method [7]
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Best overall response from radiologic assessments. [FAS]
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Timepoint [7]
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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.
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Secondary outcome [8]
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RECIST and CA-125 Response Separately and Combined
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Assessment method [8]
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RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response]
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Timepoint [8]
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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.
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Secondary outcome [9]
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Time to Earlier of CA-125 or RECIST Progression
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Assessment method [9]
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Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. [FAS]
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Timepoint [9]
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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.
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Secondary outcome [10]
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Improvement Rate for FACT-O Symptom Index (FOSI)
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Assessment method [10]
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The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. [Evaluable for FOSI set]
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Timepoint [10]
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Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
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Secondary outcome [11]
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Improvement Rate for Trial Outcome Index (TOI)
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Assessment method [11]
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The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. [Evaluable for TOI set]
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Timepoint [11]
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Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
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Secondary outcome [12]
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Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)
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Assessment method [12]
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The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. [Evaluable for FACT-O set]
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Timepoint [12]
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Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
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Secondary outcome [13]
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FACT-O Symptom Index (FOSI) Time to Worsening
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Assessment method [13]
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The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]
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Timepoint [13]
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Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
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Secondary outcome [14]
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Trial Outcome Index(TOI)Time to Worsening
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Assessment method [14]
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The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]
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Timepoint [14]
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Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
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Secondary outcome [15]
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Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening
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Assessment method [15]
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The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]
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Timepoint [15]
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Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
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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.
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/08/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/10/2023
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Sample size
Target
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Accrual to date
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Final
265
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - East Bentleigh
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Recruitment hospital [2]
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Research Site - Melbourne
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Recruitment hospital [3]
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Research Site - Randwick
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Recruitment hospital [4]
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Research Site - South Brisbane
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Recruitment postcode(s) [1]
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3165 - East Bentleigh
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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Indiana
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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Rhode Island
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Country [5]
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Austria
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State/province [5]
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Innsbruck
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Country [6]
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Austria
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State/province [6]
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Wein
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Leuven
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Canada
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British Columbia
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Country [11]
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Canada
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Ontario
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Canada
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Quebec
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Country [13]
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Czechia
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Brno
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Country [14]
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Czechia
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State/province [14]
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Olomouc
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Czechia
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Praha 10
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Estonia
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Tallinn
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Estonia
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Tartu
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France
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Bordeaux
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France
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Caen Cedex
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France
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Lyon Cedex 08
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France
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Nantes
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France
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Paris
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France
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Reims Cedex
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Germany
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Essen
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Germany
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Freiburg
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Germany
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Göttingen
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Germany
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Hannover
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Germany
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Kiel
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Germany
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Marburg
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Germany
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München
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Germany
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Ulm
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Germany
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Wiesbaden
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Israel
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Jerusalem
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Country [34]
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Israel
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Ramat Gan
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Israel
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Tel-Aviv
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Israel
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Zerifin
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Netherlands
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Amsterdam
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Poland
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Grzepnica
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Poland
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Lublin
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Poland
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Poznan
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Poland
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State/province [41]
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Warszawa
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Romania
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State/province [42]
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Cluj-Napoca
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Romania
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Iasi
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Romania
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Suceava
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Russian Federation
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Barnaul
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Russian Federation
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Ekaterinburg
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Russian Federation
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Obninsk
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Russian Federation
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Orenburg
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Russian Federation
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Perm
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Russian Federation
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Pyatigorsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Voronezh
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Spain
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Córdoba
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Spain
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Madrid
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Spain
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Valencia
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Ukraine
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Donetsk
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Ukraine
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Kyiv
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Ukraine
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Ternopil
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Ukraine
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Uzhhorod
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United Kingdom
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Edinburgh
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Sutton
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United Kingdom
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Wirral
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary purpose of this study to determine if AZD2281 is effective and well tolerated in
maintaining the improvement in your cancer after previous platinum-based chemotherapy
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00753545
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mika Sovak, BSc, MBCHB, MD
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Address
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AstraZeneca
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00753545
Download to PDF