The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000512628
Ethics application status
Approved
Date submitted
14/09/2005
Date registered
26/09/2005
Date last updated
26/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase 1/2 Pharmacokinetic and Safety Study of Oral Phenoxodiol in Patients with Hormone-Refractory Prostatic Adenocarcinoma
Scientific title
Phase 1/2 Pharmacokinetic and Safety Study of Oral Phenoxodiol in Patients with Hormone-Refractory Prostatic Adenocarcinoma
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic adenocarcinoma that is refractory to standard therapy including hormonal therapy 637 0
Condition category
Condition code
Cancer 710 710 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral Phenoxodiol in four dosage cohorts (20mg, 80mg, 200mg and 400mg three times daily).
Intervention code [1] 599 0
Treatment: Drugs
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 864 0
To determine the pharmacokinetic profile of phenoxodiol when given orally.
Timepoint [1] 864 0
Measured at day one of treatment cycle 1.
Primary outcome [2] 865 0
To determine the safety/tolerability of phenoxodiol when given orally.
Timepoint [2] 865 0
Assessed continually throughout the study.
Secondary outcome [1] 1733 0
To gain an indication of the anti-tumour activity of phenoxodiol when administered by the oral route.
Timepoint [1] 1733 0
Anti-tumour activity will be assessed by the fortnightly measurement of PSA levels.

Eligibility
Key inclusion criteria
a) Patients must have histological evidence of prostatic adenocarcinomab) Patients must have a malignancy that, in the opinion of the investigator, has become refractory to standard therapy including hormonal therapy c)Patients must be able to understand the risks and benefits of the study and give written informed consent to participation d) Patients must have an estimated life-expectancy of at least 3 months e) Patients must have -acceptable renal and hepatic function evidenced by a serum creatinine < 0.12mmol/L and serum transaminase levels <3 x the upper limit of normal for the reference laboratory-bilirubin < 20umol/L-adequate haematological function defined by platelets > 100x109/L , WCC > 4x109/L, Hb > 10g/dL, neutrophils > 1.5 x 109 /L f) Patients engaging in sexual activity must (i) agree to use contraception, or (ii) ensure that their sexual partner be using contraception which must be either oral contraceptives, implantable hormonal contraceptives, or double-barrier methods, if of child-bearing potential.
Minimum age
18 Years
Maximum age
Not stated
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
a) Patients may not be on a concurrent investigational drug study and must be off treatment with any investigational agents for at least 4 weeksb) Patients may not have active infectionc) Patients may not have active CNS metastases. Patients with known CNS metastases must have received prior radiation therapy, and CNS metastatic disease must be stable for 4 weeks.d) Patients must have recovered from the effects of any prior anti-neoplastic therapy.

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
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 786 0
Commercial sector/Industry
Name [1] 786 0
Marshall Edwards Pty Ltd
Address [1] 786 0
Country [1] 786 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Marshall Edwards Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 650 0
None
Name [1] 650 0
Not Applicable
Address [1] 650 0
Country [1] 650 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2071 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 2071 0
Ethics committee country [1] 2071 0
Australia
Date submitted for ethics approval [1] 2071 0
Approval date [1] 2071 0
Ethics approval number [1] 2071 0
Ethics committee name [2] 2072 0
Monash Medical Centre
Ethics committee address [2] 2072 0
Ethics committee country [2] 2072 0
Australia
Date submitted for ethics approval [2] 2072 0
Approval date [2] 2072 0
Ethics approval number [2] 2072 0

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

Contacts
Principal investigator
Name 35969 0
Address 35969 0
Country 35969 0
Phone 35969 0
Fax 35969 0
Email 35969 0
Contact person for public queries
Name 9788 0
Sue Davies
Address 9788 0
Suite 1
10 McCourt Street
Leederville WA 6007
Country 9788 0
Australia
Phone 9788 0
+61 8 93822373
Fax 9788 0
Email 9788 0
tulloch@p085.aone.net.au
Contact person for scientific queries
Name 716 0
Sue Davies
Address 716 0
Suite 1
10 McCourt Street
Leederville WA 6007
Country 716 0
Australia
Phone 716 0
+61 8 93822373
Fax 716 0
Email 716 0
tulloch@p085.aone.net.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary