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Trial registered on ANZCTR


Registration number
ACTRN12606000520538
Ethics application status
Approved
Date submitted
12/12/2006
Date registered
18/12/2006
Date last updated
13/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase I accelerated dose-escalation study of CYT997 given as an oral capsule every two weeks in patients with advanced solid tumours
Scientific title
Phase I accelerated dose-escalation study to determine the safety and tolerability of CYT997 when given as an oral capsule every two weeks in patients with advanced solid tumours
Secondary ID [1] 252204 0
CCL06001
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 1495 0
Condition category
Condition code
Cancer 1592 1592 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CYT997 administered as an oral capsule dose on a two weekly cycle for up to six cycles. The starting dose is 15mg/m2 and the dose escalates at 1.4x the previous dose. Dose escalation may occur every two weeks (ie at the completion of the first cycle for each successive patient in the dose-escalation phase). Dose-escalation will cease at the occurrence of drug-related Grade 4 neutropenia lasting 5 days or longer or associated with fever requiring antibiotics; Grade 4 thrombocytopenia or non-haematological toxicity of Grade 3 or greater (excluding nausea, vomiting and diarrhoea with optimal treatment).
Intervention code [1] 1502 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2196 0
To establish the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of CYT997 following oral administration. For an adverse event to qualify as a dose-limiting toxicity it must occur in the first cycle of therapy (for each patient). Dose-escalation ceases when an adverse event which qualifies as a DLT occure in the first cycle of a given dose level and, in accordance with the protocol, further patients are enrolled at this dose level until the sooner of a second DLT or 6 patients are enrolled in total. When a second DLT does occur, no further patients are enrolled at this dose and the MTD is determined. Further patients may be enrolled at the previous dose level to define the recommended dose for Phase II studies.
Timepoint [1] 2196 0
DLTs are assessed throughout the first cycle and the MTD is determined when two or more DLTs occur at a particular dose level.
Secondary outcome [1] 3826 0
(i) To study the pharmacokinetics of CYT997 following oral administration
Timepoint [1] 3826 0
After dose administration in the first and second cycles
Secondary outcome [2] 3827 0
(ii) To characterise the toxicities and tolerability of CYT997 following oral administration
Timepoint [2] 3827 0
Continuously throughout the study
Secondary outcome [3] 3828 0
(iii) To define a recommended dose for oral Phase II studies
Timepoint [3] 3828 0
Following determination of the MTD
Secondary outcome [4] 3829 0
(iv) To make a preliminary evaluation of anti-tumour activity
Timepoint [4] 3829 0
After every second cycle of drug
Secondary outcome [5] 3830 0
(v) To make a preliminary evaluation of vascular-targetting activity
Timepoint [5] 3830 0
From data acquired during the first cycle
Secondary outcome [6] 3831 0
(vi) To assess pharmacokinetic/pharmacodynamic relationships
Timepoint [6] 3831 0
From data collected in the first cycle

Eligibility
Key inclusion criteria
(i) Confirmed solid malignancy; (ii) Life-expectancy of greater than 3 months; (iii) No anticancer chemotherapy or hormonal therapy for the preceding 4 weeks; (iv) Adequate organ and marrow function.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Patients must not have received other experimental agents in preceding 4 weeks; (ii) Known brain metastases; (iii) Patients with various cardiovascular risk factors are excluded; (iv) Pregnancy and immune deficiency.

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
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,QLD,SA

Funding & Sponsors
Funding source category [1] 1737 0
Commercial sector/Industry
Name [1] 1737 0
Cytopia Research Pty Ltd
Country [1] 1737 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cytopia Research Pty Ltd
Address
576 Swan St, Richmond, Victoria, 3121.
Country
Australia
Secondary sponsor category [1] 1532 0
None
Name [1] 1532 0
Nil
Address [1] 1532 0
Country [1] 1532 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3214 0
Department of Medical Oncology Royal Brisbane and Women's Hospital
Ethics committee address [1] 3214 0
Ethics committee country [1] 3214 0
Australia
Date submitted for ethics approval [1] 3214 0
Approval date [1] 3214 0
06/12/2006
Ethics approval number [1] 3214 0
2006/147
Ethics committee name [2] 3215 0
Q-Pharm Pty Ltd-Queensland Institute of Medical Research HREC
Ethics committee address [2] 3215 0
Ethics committee country [2] 3215 0
Australia
Date submitted for ethics approval [2] 3215 0
Approval date [2] 3215 0
13/10/2006
Ethics approval number [2] 3215 0
H0610-047T (P1035)
Ethics committee name [3] 5966 0
Southern Health Human Research Ethics Committee
Ethics committee address [3] 5966 0
Ethics committee country [3] 5966 0
Australia
Date submitted for ethics approval [3] 5966 0
23/05/2008
Approval date [3] 5966 0
01/09/2008
Ethics approval number [3] 5966 0
08002A
Ethics committee name [4] 5969 0
Bellberry Human Research Ethics Committee
Ethics committee address [4] 5969 0
Ethics committee country [4] 5969 0
Australia
Date submitted for ethics approval [4] 5969 0
01/03/2008
Approval date [4] 5969 0
07/04/2008
Ethics approval number [4] 5969 0
New ethics HREC. Please modify.

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

Contacts
Principal investigator
Name 27436 0
Address 27436 0
Country 27436 0
Phone 27436 0
Fax 27436 0
Email 27436 0
Contact person for public queries
Name 10691 0
Dr Gregg Smith
Address 10691 0
576 Swan St, Richmond, Victoria, 3121.
Country 10691 0
Australia
Phone 10691 0
+61 3 9208 4222
Fax 10691 0
Email 10691 0
[email protected]
Contact person for scientific queries
Name 1619 0
Dr Gregg Smith
Address 1619 0
576 Swan St, Richmond, Victoria, 3121.
Country 1619 0
Australia
Phone 1619 0
+61 3 9208 4222
Fax 1619 0
+61 3 9208 4299
Email 1619 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.