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Trial registered on ANZCTR


Registration number
ACTRN12605000793617
Ethics application status
Approved
Date submitted
14/12/2005
Date registered
16/12/2005
Date last updated
12/11/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase I dose-escalation study for CYT997
Scientific title
Phase I dose-escalation study of CYT997 given as a 24-hour intravenous infusion every three weeks in patients with advanced solid tumours
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer - solid malignancies that are metastatic or unresectable 952 0
Condition category
Condition code
Cancer 1021 1021 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CYT997 administered as a 24 hour intravenous infusion every three weeks
Intervention code [1] 804 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1369 0
To establish the dose-limiting toxicities of CYT997 given as a 24-hour continuous intravenous infusion
Timepoint [1] 1369 0
From data collected during the first cycle.
Primary outcome [2] 1370 0
To establish the maximum tolerated dose of CYT997 given as a 24-hour continuous intravenous infusion
Timepoint [2] 1370 0
From data collected during the first cycle.
Secondary outcome [1] 2422 0
(i) To study the pharmacokinetics of CYT997
Timepoint [1] 2422 0
From data collected during the first and second cycles.
Secondary outcome [2] 2423 0
(ii) To characterise the toxicities and tolerability of CYT997
Timepoint [2] 2423 0
From data collected throughout the study.
Secondary outcome [3] 2424 0
(iii) To define a recommended dose for Phase II studies
Timepoint [3] 2424 0
From data collected during the first cycle.
Secondary outcome [4] 2425 0
(iv) To make a preliminary evaluation of anti-tumour activity
Timepoint [4] 2425 0
From data collected throughout the study.
Secondary outcome [5] 2426 0
(v) To make a preliminary evaluation of vascular-targetting activity
Timepoint [5] 2426 0
From data collected during the first cycle.
Secondary outcome [6] 2427 0
(vi) To assess for pharmacokinetic/pharmacodynamic relationships
Timepoint [6] 2427 0
From data collected during the first cycle.

Eligibility
Key inclusion criteria
(i) Patients must have solid malignancy that is metastatic or unresectable and for which standard curative or palliative anti-neoplastic treatments do not exist or are no longer effective.(ii) Life-expectancy of greater than 3 months(iii) No anti-cancer chemotherapy or hormonal therapy for the preceding 4 weeks(iv) Patients must have adequate organ and marrow function(v) Willing to give informed consent.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Patients must not have received other investigational agents within the preceding 4 weeks(ii) Patients with known brain metastases are excluded from the trial(iii) As CYT997 may have vascular targetting activity, patients with various cardiovascular risk factors (including MI or stroke within 6 months; unstable angina; symptomatic peripheral artery disease etc) are excluded(iv) Pregnant women and patients with immune deficiency are also excluded.

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
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
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] 1123 0
Commercial sector/Industry
Name [1] 1123 0
Cytopia Research Pty Ltd
Address [1] 1123 0
75 Commercial Rd, Prahran, Victoria, 3004.
Country [1] 1123 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cytopia Research Pty Ltd
Address
75 Commercial Rd, Prahran, Victoria, 3004.
Country
Australia
Secondary sponsor category [1] 981 0
None
Name [1] 981 0
Nil
Address [1] 981 0
Country [1] 981 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2440 0
Department of Medical Oncology Royal Brisbane and Women's Hospital
Ethics committee address [1] 2440 0
Butterfield Street, Herston, Qld
Ethics committee country [1] 2440 0
Australia
Date submitted for ethics approval [1] 2440 0
Approval date [1] 2440 0
05/04/2005
Ethics approval number [1] 2440 0
2005/007
Ethics committee name [2] 2441 0
Q-Pharm Pty Ltd
Ethics committee address [2] 2441 0
300C Herston Road, Herston, Qld
Ethics committee country [2] 2441 0
Australia
Date submitted for ethics approval [2] 2441 0
Approval date [2] 2441 0
15/03/2005
Ethics approval number [2] 2441 0
H0502-005T (P857)

Summary
Brief summary
CYT997 is an experimental anticancer agent with vascular targetting activity. This Phase I trial aims to determine the safety and tolerability of CYT997 when given as a 24-hour intravenous infusion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35674 0
Address 35674 0
Country 35674 0
Phone 35674 0
Fax 35674 0
Email 35674 0
Contact person for public queries
Name 9993 0
Dr Gregg Smith
Address 9993 0
Cytopia Research Pty Ltd
75 Commercial Road
Prahran VIC 3004
Country 9993 0
Australia
Phone 9993 0
+61 3 95226900
Fax 9993 0
+61 3 9510 9291
Email 9993 0
gregg.smith@cytopia.com.au
Contact person for scientific queries
Name 921 0
Dr Gregg Smith
Address 921 0
Cytopia Research Pty Ltd
75 Commercial Road
Prahran VIC 3004
Country 921 0
Australia
Phone 921 0
+61 3 95226900
Fax 921 0
+61 3 9510 9291
Email 921 0
gregg.smith@cytopia.com.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