Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000334000
Ethics application status
Approved
Date submitted
22/04/2010
Date registered
28/04/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pharmacokinetics of NV06 in patients with advanced cancer
Scientific title
Pharmacokinetics of phenoxodiol, a novel isoflavone, following intravenous administration to patients with advanced cancer
Secondary ID [1] 251654 0
nil
Universal Trial Number (UTN)
U1111-1114-6766
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetics of a novel isoflavone, phenoxodiol 257142 0
Pharmacokinetics of phenoxodiol after an intravenous bolus and after an intravenous infusion in patients with advanced cancer 257232 0
Cancer 257253 0
Condition category
Condition code
Cancer 257299 257299 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ntravenous phenoxodiol was given to cancer patients in two schedules: bolus (5mg/kg) and continuous infusion (2mg/kg/hr) up to 10 half-lives determined from the bolus infusion part of the study. The infusion was given 41-98 days after the bolus dose.
Intervention code [1] 256297 0
Treatment: Drugs
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258206 0
Pharmacokinetic behaviour of NV06 (phenoxodiol) as assessed by blood analysis
Timepoint [1] 258206 0
Variable timepoints were used in the assessment of phenoxodiol pharmacokinetics, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0 and 12.0 hours after infusion.
Secondary outcome [1] 263856 0
Nil
Timepoint [1] 263856 0
Nil

Eligibility
Key inclusion criteria
Male or females with metastatic disease from any solid tumour, age 18 to 70 years, normal haematological parameters and the provision of signed informed consent
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Leukemia or lymphoma, allergy to soy products, vegetarian diet or use of soy product more than three times a week, the use of sex steroids in the previous two months, antibiotic therapy within one month prior to the study period or at any time during the study, smoking of greater than 10 cigarettes/day, a prognosis of at least three months, and the known presence of central nervous system metastases, active infection or other co-morbid disease

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)
Patients with metastatic disease who had refused or failed at least one line of therapy were offered the opportunity to volunteer for this pharmacokinetic study. There was no randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/05/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 256796 0
Commercial sector/Industry
Name [1] 256796 0
Novogen Pty Ltd
Country [1] 256796 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Novogen Pty Ltd
Address
140 Wicks Road. NORTH RYDE NSW 2113
Country
Australia
Secondary sponsor category [1] 256071 0
None
Name [1] 256071 0
Address [1] 256071 0
Country [1] 256071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258819 0
St George Hospital
Ethics committee address [1] 258819 0
Gray Street
Kogarah, NSW 2217
Ethics committee country [1] 258819 0
Australia
Date submitted for ethics approval [1] 258819 0
Approval date [1] 258819 0
Ethics approval number [1] 258819 0

Summary
Brief summary
The study investigated the pharmacokinetics of phenoxodiol given as an intravenous bolus and a continuous intravenous infusion in a first-in-human study, to patients with advanced cancer.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 31041 0
Address 31041 0
Country 31041 0
Phone 31041 0
Fax 31041 0
Email 31041 0
Contact person for public queries
Name 14288 0
Leanne West
Address 14288 0
140 Wicks Road, Ryde, NSW, 2113
Country 14288 0
Australia
Phone 14288 0
+612 9878 0088.
Fax 14288 0
+612 9878 0055
Email 14288 0
[email protected]
Contact person for scientific queries
Name 5216 0
Dr. Paul de Souza
Address 5216 0
Cancer Care Centre
St George Hospital
Gray Street, Kogarah
NSW, 2217
Country 5216 0
Australia
Phone 5216 0
+612-91133910
Fax 5216 0
+612-91133958
Email 5216 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
SourceTitleYear of PublicationDOI
EmbasePharmacokinetics of phenoxodiol, a novel isoflavone, following intravenous administration to patients with advanced cancer.2011https://dx.doi.org/10.1186/1472-6904-11-1
N.B. These documents automatically identified may not have been verified by the study sponsor.