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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/NCT00707707




Registration number
NCT00707707
Ethics application status
Date submitted
27/06/2008
Date registered
1/07/2008
Date last updated
6/03/2018

Titles & IDs
Public title
Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer
Scientific title
Phase I/II Randomised, Double- Blind, Multi-centre Study to Assess the Efficacy of AZD2281 When Given in Combination With Paclitaxel in the 1st or 2nd Line Treatment of Patients With Metastatic Triple Negative Breast Cancer.
Secondary ID [1] 0 0
D0810C00011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Triple Negative Breast Cancer 0 0
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD2281
Treatment: Drugs - Paclitaxel

Experimental: 1 - paclitaxel + AZD2281


Treatment: Drugs: AZD2281
Dose finding study to establish the appropriate dose of AZD2281

Treatment: Drugs: Paclitaxel
Intravenous infusion over 1 hour
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis
Timepoint [1] 0 0
Physical examination/ ECG approximately monthly.Adverse Events, Vital signs, Haematology/ clinical chemistry, Urinalysis weekly throughout the study

Eligibility
Key inclusion criteria
- patients with histologically or cytologically diagnosed metastatic triple negative
breast cancer (Oestrogen, progesterone and HER2 negative adenocarcinoma of the breast)

- Patients must have normal organ and bone marrow function, ECOG performance status of
no more than 2

- Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer
must be available for central testing.
Minimum age
18 Years
Maximum age
130 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any chemotherapy, radiotherapy (except for palliative reasons) or investigational
product, within 2 weeks from the last dose prior to study entry (or longer period,
depending on the agent used)

- Major surgery within 4 weeks of starting the study, and must have recovered from any
effects of major surgery

- Patients requiring treatment with the following:certain antibiotic drugs, St.John's
Wort, carbamazepine, phenobarbitone, phenytoin, and certain protease inhibitors/
non-nucleoside reverse transcriptase inhibitors used as components of HIV/AIDS
treatment,

- Patients with second primary cancer; except adequately treated non-melanoma skin
cancer, curatively treated in-situ cancer of the cervix, or other solid tumours
curatively treated with no evidence of disease for at least 5 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 1
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
15/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/02/2018
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Auchenflower
Recruitment hospital [2] 0 0
Research Site - Parkville
Recruitment hospital [3] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario

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

Ethics approval
Ethics application status

Summary
Brief summary
This is the first part of a 2-part study assessing the efficacy of AZD2281 in combination
with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative
breast cancer. This first part (Phase I) is an open-label, intra patient dose finding study
to establish the appropriate doses and schedule of paclitaxel and AZD2281 in combination, to
be used in the randomized Phase II part. The safety and tolerability of AZD2281 in
combination with paclitaxel will be explored. Approximately 10 patients per cohort from 4-5
countries will be enrolled in Phase I.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00707707
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rebecca Dent, MD
Address 0 0
Sunnybrook Health Sciences Centre, Toronto
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