Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000345583
Ethics application status
Approved
Date submitted
24/07/2006
Date registered
11/08/2006
Date last updated
26/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase Ia Safety and Pharmacokinetic Study of Oral NV-196 in Patients with Solid Tumours
Scientific title
Phase Ia Safety and Pharmacokinetic Study of Oral NV-196 in Patients with Solid Tumours
Secondary ID [1] 287 0
Marshall Edwards Pty Ltd: NV196-0001
Secondary ID [2] 481 0
NA
Secondary ID [3] 482 0
NA
Secondary ID [4] 483 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid tumors 1316 0
Patients with solid tumors 2496 0
Condition category
Condition code
Cancer 1401 1401 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NV-196 capsules -oral dosage formulation
There is no dose increments. We have acute dosing and chronic dosing.
Acute dosing on day 1- 100 mg once a day
Chronic dosing starts on day 3 up to day 8 in the morning. On days 3 to 7 - patients will have 100 mg three times per day and on day 8 the last dose - 100 mg only in the morning.
Intervention code [1] 1224 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1918 0
a) to determine the safety and tolerability of repeated doses of oral NV-196 in patients with solid tumours.
The study is 9 days long .
Timepoint [1] 1918 0
The outcomes will be monitored on days 1,2,5,8 and 9 and there will be a follow- up visit 28 days from last dose.
Primary outcome [2] 1919 0
b)to determine the pharmacokinetics of NV-196 and its metabolite NV-143 after single and multiple oral dosing in patients with solid tumours.
The study is 9 days long .
Timepoint [2] 1919 0
The outcomes will be monitored on days 1,2,5,8 and 9 and there will be a follow- up visit 28 days from last dose.
Secondary outcome [1] 3377 0
NA
Timepoint [1] 3377 0

Eligibility
Key inclusion criteria
Patients meeting all of the following criteria will be considered for admission to the study:a)Patients must have a solid malignancy that has become stable on current treatment. For the purposes of this study, stable disease is defined as no change of anti-cancer therapy within the last 28 days (hormone therapy or on observation), not including supportive therapies. Patients just completing chemotherapy or radiotherapy are eligible, provided these treatments were last administered more than 28 days prior to NV-196 administration.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 and hepatic function evidenced by a serum creatinine < 1.5 mg/dl and serum transaminase levels less than or equal to 3 x the upper limit of normal for the reference laboratory •bilirubin < 20 micro mol/L,•adequate haematological function. e)Patients must have a Karnofsky Performance Score of at least 60%. f)Patients of childbearing potential must agree to use an acceptable method of contraception. g)Patients have no evidence of central nervous system malignancy.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients presenting with any of the following will not be included in the study:a)Patients who are on a concurrent investigational drug study or who have had any treatment with any investigational agents within 4 weeks of commencing the study.b)Patients with active infection.c)Patients who have not recovered from the acute effects of any prior anti-neoplastic therapy or radiotherapy.d)Patients who, in the opinion of the investigator, are more suitable for active treatment with an anti-cancer agent.e)Patients with concurrent severe and/or uncontrolled medical disease (eg. uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure, etc.).f)Patients with a history of chronic active hepatitis or liver cirrhosis.g)Patients with HIV.h)Patients who are pregnant or lactating.

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
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1535 0
Commercial sector/Industry
Name [1] 1535 0
The same name
Country [1] 1535 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Address
140 Wicks Rd, North Ryde , NSW
Country
Australia
Secondary sponsor category [1] 1349 0
None
Name [1] 1349 0
Nil
Address [1] 1349 0
Country [1] 1349 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2965 0
Mater Hospital
Ethics committee address [1] 2965 0
Mater Adult Hospital- Research OfficeRaymond Terrace
South Brisbane, QLD 4101
Ethics committee country [1] 2965 0
Australia
Date submitted for ethics approval [1] 2965 0
Approval date [1] 2965 0
29/06/2006
Ethics approval number [1] 2965 0
NV196-0001

Summary
Brief summary
The proposed study represents the second stage in the clinical development of NV-196.

The purpose of this study is to deliver the drug over a longer period of time in order (a) to identify a dosage regimen that will deliver a steady state level of drug in the blood, and (b) to characterise the safety profile of the drug.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35276 0
Address 35276 0
Country 35276 0
Phone 35276 0
Fax 35276 0
Email 35276 0
Contact person for public queries
Name 10413 0
Ken Musgrave
Address 10413 0
Mater Hospital
Medical School Building
Level 3
Raymond Terrace
South Brisbane QLD 4101
Country 10413 0
Australia
Phone 10413 0
+61 7 38408697
Fax 10413 0
+61 7 38402834
Email 10413 0
[email protected]
Contact person for scientific queries
Name 1341 0
Ken Musgrave
Address 1341 0
Mater Hospital
Medical School Building
Level 3
Raymond Terrace
South Brisbane QLD 4101
Country 1341 0
Australia
Phone 1341 0
+61 7 38408697
Fax 1341 0
+61 7 38402834
Email 1341 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.