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
ACTRN12605000453684
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
21/09/2005
Date last updated
26/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase I Dose escalation study of Oral Phenoxodiol in combination with Cisplatin or Carboplatin in Patients with Advanced Malignancies
Scientific title
Phase I Dose escalation study of Oral Phenoxodiol in combination with Cisplatin or Carboplatin in Patients with Advanced Malignancies
Secondary ID [1] 172 0
Novogen: NV06-0034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
No change 568 0
Condition category
Condition code
Cancer 644 644 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phenoxodiol oral dosage formulation in combination with cisplatin or carboplatin for 6 month.
Intervention code [1] 519 0
Treatment: Drugs
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 755 0
To determine the recommended phase II dose of phenoxodiol in combination with cisplatin or carboplatin for further studies.
Timepoint [1] 755 0
Measured on weekly basis (pharmacokinetics, safety, tumor markers) and every 3 months (CT scan).
Secondary outcome [1] 1548 0
To determine the pharmacokinetic and safety profiles of phenoxodiol in combination with cisplatin or carboplatin.
Timepoint [1] 1548 0
Measured on weekly basis (pharmacokinetics, safety, tumor markers) and every 3 month (CT scan).
Secondary outcome [2] 1549 0
To gain a preliminary indication of the anti-tumour activity of phenoxodiol when administered in combination with cisplatin or carboplatin.
Timepoint [2] 1549 0
Measured on weekly basis (pharmacokinetics, safety, tumor markers) and every 3 month (CT scan).

Eligibility
Key inclusion criteria
Patients meeting all of the following criteria will be considered for the study:a) Patients must have a malignancy that has progressed since treatment with at least one previous standard therapy, or where standard therapy for their disease has been refused, or where no standard therapy exists b) Patients must be able to understand the risks and benefits of the study and give written informed consent to participation. c) Patients must have an estimated life-expectancy of at least 3 months. d) Patients must have acceptable renal function as determined by a serum creatinine less than or equal to 0.15mmol/L. In addition, Glomerular Filtration Rate (GFR) as measured by isotope scan or by calculation using the Cockcroft Gault formula should be >40ml/min (Appendix I). acceptable hepatic function defined by serum transaminase levels less than or equal to 3 x the upper limit of normal for the reference laboratory. If tumour involves the liver, then transaminases should be less than or equal to 5 x the upper limit of normal are acceptable. Isolated hyperbilirubinemia (up to 2 x ULN) is acceptable adequate haematological function as defined by platelets > 100x109/L , WCC > 3x109/L, Hb > 10g/dL (>9g/dL for females), neutrophils > 1.5 x 109 /Lh) Patients of childbearing potential must agree to use an acceptable method of contraception.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with any of the following will not be included in the study:a) Patients being treated concurrently with an investigational drug. Patients must be off treatment with any investigational agents for at least 3 weeks (patients may have had previous treatment with single agent phenoxodiol) provided all previous toxicity has resolvedb)Patients who are pregnant or lactatingc) Patients who have active, untreated infectiond)Patients who have active CNS metastases. Patients with known CNS metastases must have received prior surgery or radiation therapy, and CNS metastatic disease must be stable for at least 4 weeks prior to study entry.e)Patients who have breast cancer.f)Patients must have recovered from the effects of any prior anti-neoplastic therapy, and at least 3 weeks must have elapsed prior to study entryg)Patients who are on concurrent medications known to be metabolized by cytochrome P450 enzymes (Appendix E) may be excluded at the discretion of the investigator if assessed as being at high risk for significant drug interactions with phenoxodiol. Patients are not automatically excluded from this study however, simply because their concurrent medications includes any of those listed in Appendix E.

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
Type of endpoint(s)
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 704 0
Commercial sector/Industry
Name [1] 704 0
Same
Address [1] 704 0
140 Wicks Rd, North Ryde, NSW
Country [1] 704 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Marshall Edwards Pty Ltd
Address
140 Wicks Rd. North Ryde, NSW
Country
Australia
Secondary sponsor category [1] 589 0
None
Name [1] 589 0
NA
Address [1] 589 0
Country [1] 589 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35468 0
Address 35468 0
Country 35468 0
Phone 35468 0
Fax 35468 0
Email 35468 0
Contact person for public queries
Name 9708 0
Cecilia Chen
Address 9708 0
Cancer Care Centre
St George Hospital
Gray St
Kogarah NSW 2217
Country 9708 0
Australia
Phone 9708 0
+61 2 93503829
Fax 9708 0
Email 9708 0
Chan.Cecilia@SESIAHS.HEALTH.NSW.GOV.AU
Contact person for scientific queries
Name 636 0
Cecilia Chen
Address 636 0
Cancer Care Centre
St George Hospital
Gray St
Kogarah NSW 2217
Country 636 0
Australia
Phone 636 0
+61 2 93503829
Fax 636 0
Email 636 0
Chan.Cecilia@SESIAHS.HEALTH.NSW.GOV.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