Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000393651
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
14/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Pharmacogenetic and Pathological Assessment of CYP2C19 Activity in Patients with Advanced Cancer
Scientific title
The Pharmacogenetic and Pathological Assessment of CYP2C19 Activity in Patients with Advanced Cancer as determined by omeprazole metabolism
Secondary ID [1] 161 0
Clinical Trials New Zealand: CTNZ_
Universal Trial Number (UTN)
Trial acronym
CYP2C19
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced cancer 497 0
Condition category
Condition code
Cancer 577 577 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Omeprazole
Intervention code [1] 371 0
Treatment: Drugs
Comparator / control treatment
Control group
Historical

Outcomes
Primary outcome [1] 670 0
The primary aim of this exploratory study is to determine whether advanced cancer results in a decreased functional activity of CYP2C19, independent of genotype, as assessed by metabolism of a single dose of omeprazole
Timepoint [1] 670 0
At 2 hours post administration
Secondary outcome [1] 1377 0
To determine whether decreased CYP2C19 function correlates with markers of disease severity as determined by circulating inflammatory cytokines (IL1, IL6 & TNF-α) and a marker of acute phase response, C-reactive protein.
Timepoint [1] 1377 0

Eligibility
Key inclusion criteria
Patients with advanced cancer who last received cytotoxic or hormonal therapy for their cancer more than four weeks ago and who are being considered for a new line of therapy for disease progression or inadequate response to prior therapy; adequate renal and liver function; Patients must be able to provide informed consent
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients receiving medication which is either a CYP2C19 inhibitor or inducer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 171 0
New Zealand
State/province [1] 171 0

Funding & Sponsors
Funding source category [1] 627 0
Charities/Societies/Foundations
Name [1] 627 0
Cancer Society New Zealand
Country [1] 627 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Trials New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 512 0
None
Name [1] 512 0
-
Address [1] 512 0
Country [1] 512 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35162 0
Address 35162 0
Country 35162 0
Phone 35162 0
Fax 35162 0
Email 35162 0
Contact person for public queries
Name 9560 0
Professor Michael Findlay
Address 9560 0
Clinical Trials New Zealand
Discipline of Oncology
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland
Country 9560 0
New Zealand
Phone 9560 0
+64 9 3737599
Fax 9560 0
+64 9 3737927
Email 9560 0
[email protected]
Contact person for scientific queries
Name 488 0
Dr Nicole McCarthy
Address 488 0
Discipline of Oncology
Faculty of Medical & Health Sciences
University of Auckland
Private Bag 92019
Auckland
Country 488 0
New Zealand
Phone 488 0
+64 9 3737599
Fax 488 0
+64 9 3737927
Email 488 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.