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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
000945
ACTR Number:
ACTRN12605000793617
Trial Status:
Registered
Date Submitted:
14/12/2005
Date Registered:
16/12/2005
Page 1
Public title:
Phase I dose-escalation study for CYT997
Update:
Reason:
ANZCTR registration title:
Phase I dose-escalation study of CYT997 given as a 24-hour intravenous infusion every three weeks in patients with advanced solid tumours
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Reason:
Secondary ID:
UTN:
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Trial acronym:
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Page 2
Health condition(s) or problem(s) studied:
Cancer - solid malignancies that are metastatic or unresectable
Condition category:
Condition code:
Cancer
Other cancer types
Page 3
Description of intervention(s) / exposure:
CYT997 administered as a 24 hour intravenous infusion every three weeks
Update:
Reason:
Intervention code:
Treatment: drugs
Comparator / control treatment:
No control group.
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Reason:
Control group:
Uncontrolled
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Reason:
Page 4
Primary outcome 1:
To establish the dose-limiting toxicities of CYT997 given as a 24-hour continuous intravenous infusion
Timepoint:
From data collected during the first cycle.
Primary outcome 2:
To establish the maximum tolerated dose of CYT997 given as a 24-hour continuous intravenous infusion
Timepoint:
From data collected during the first cycle.
Secondary outcome 1:
(i) To study the pharmacokinetics of CYT997
Timepoint:
From data collected during the first and second cycles.
Secondary outcome 2:
(ii) To characterise the toxicities and tolerability of CYT997
Timepoint:
From data collected throughout the study.
Secondary outcome 3:
(iii) To define a recommended dose for Phase II studies
Timepoint:
From data collected during the first cycle.
Secondary outcome 4:
(iv) To make a preliminary evaluation of anti-tumour activity
Timepoint:
From data collected throughout the study.
Secondary outcome 5:
(v) To make a preliminary evaluation of vascular-targetting activity
Timepoint:
From data collected during the first cycle.
Secondary outcome 6:
(vi) To assess for pharmacokinetic/pharmacodynamic relationships
Timepoint:
From data collected during the first cycle.
Page 5
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.
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Reason:
Minimum Age:
18
Years
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Reason:
Maximum Age:
Not stated
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Reason:
Gender:
Both males and females
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Reason:
Healthy volunteers?
No
Update:
Reason:
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.
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Reason:
Page 6
Study type:
Interventional
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Reason:
Purpose of the study:
Treatment
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Allocation to intervention:
Nonrandomised trial
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Reason:
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
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Reason:
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
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Reason:
Masking / blinding:
Open (masking not used)
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Reason:
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Assignment:
Other
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Reason:
Other design features (specify):
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Type of endpoint(s):
Safety
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Reason:
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Page 7
Phase
Phase 1
Update:
Reason:
Anticipated or actual date of first participant enrolement:
14/06/2005
Update:
Reason:
Target sample size:
24
Update:
Reason:
Recruitment status:
Completed
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Reason:
Page 8
Funding source:
Commercial sector/Industry
Name:
Cytopia Research Pty Ltd
Address:
75 Commercial Rd, Prahran, Victoria, 3004.
Country:
Australia
Primary sponsor:
Commercial sector/Industry
Update:
Reason:
Name:
Cytopia Research Pty Ltd
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Reason:
Address:
75 Commercial Rd, Prahran, Victoria, 3004.
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Reason:
Country:
Australia
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Reason:
Secondary sponsor:
None
Name:
Nil
Address:
Country:
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
Ethics Committee name 1:
Department of Medical Oncology Royal Brisbane and Women's Hospital
Address:
Butterfield Street, Herston, Qld
Country:
Australia
Date of approval:
5/04/2005
HREC Number:
2005/007
Ethics Committee name 2:
Q-Pharm Pty Ltd
Address:
300C Herston Road, Herston, Qld
Country:
Australia
Date of approval:
15/03/2005
HREC Number:
H0502-005T (P857)
Countries of recruitment:
Australia
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.
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Reason:
Trial website:
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Presentations / publication list:
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Page 10
Contact person for public queries
Name:
Dr Gregg Smith
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Reason:
Address:
Cytopia Research Pty Ltd 75 Commercial Road Prahran VIC 3004
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Reason:
Country:
Australia
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Reason:
Tel:
+61 3 95226900
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Reason:
Fax:
+61 3 9510 9291
Update:
Reason:
Email:
gregg.smith@cytopia.com.au
Update:
Reason:
Contact person for scientific queries
Name:
Dr Gregg Smith
Update:
Reason:
Address:
Cytopia Research Pty Ltd 75 Commercial Road Prahran VIC 3004
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
+61 3 95226900
Update:
Reason:
Fax:
+61 3 9510 9291
Update:
Reason:
Email:
gregg.smith@cytopia.com.au
Update:
Reason:
Contact person responsible for updating information
Name:
Dr Gregg Smith
Update:
Reason:
Address:
Cytopia Research Pty Ltd, 75 Commercial Rd, Prahran, Victoria, 3004
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
+61 3 9522 6900
Update:
Reason:
Fax:
+61 3 9510 9291
Update:
Reason:
Email:
gregg.smith@cytopia.com.au
Update:
Reason:
