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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:
081754
ACTR Number:
ACTRN12606000520538
Trial Status:
Registered
Date Submitted:
12/12/2006
Date Registered:
18/12/2006
Page 1
Public title:
Phase I accelerated dose-escalation study of CYT997 given as an oral capsule every two weeks in patients with advanced solid tumours
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Reason:
ANZCTR registration 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
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Reason:
Secondary ID:
CCL06001
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 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).
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Intervention code:
Treatment: drugs
Comparator / control treatment:
No comparator.
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Control group:
Uncontrolled
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Page 4
Primary outcome:
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:
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:
(i) To study the pharmacokinetics of CYT997 following oral administration
Timepoint:
After dose administration in the first and second cycles
Secondary outcome 2:
(ii) To characterise the toxicities and tolerability of CYT997 following oral administration
Timepoint:
Continuously throughout the study
Secondary outcome 3:
(iii) To define a recommended dose for oral Phase II studies
Timepoint:
Following determination of the MTD
Secondary outcome 4:
(iv) To make a preliminary evaluation of anti-tumour activity
Timepoint:
After every second cycle of drug
Secondary outcome 5:
(v) To make a preliminary evaluation of vascular-targetting activity
Timepoint:
From data acquired during the first cycle
Secondary outcome 6:
(vi) To assess pharmacokinetic/pharmacodynamic relationships
Timepoint:
From data collected in the first cycle
Page 5
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.
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Reason:
Minimum Age:
18
Years
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Maximum Age:
Not stated
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Gender:
Both males and females
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Healthy volunteers?
No
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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.
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Page 6
Study type:
Interventional
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Purpose of the study:
Treatment
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Allocation to intervention:
Nonrandomised trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
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Masking / blinding:
Open (masking not used)
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Reason:
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Assignment:
Single group
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Other design features (specify):
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Type of endpoint(s):
Safety
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Page 7
Phase
Phase 1
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Reason:
Anticipated or actual date of first participant enrolement:
12/12/2006
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Reason:
Target sample size:
15
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Recruitment status:
Completed
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Reason:
Page 8
Funding source:
Commercial sector/Industry
Name:
Cytopia Research Pty Ltd
Address:
576 Swan St, Richmond, Victoria, 3121.
Country:
Australia
Primary sponsor:
Commercial sector/Industry
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Reason:
Name:
Cytopia Research Pty Ltd
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Reason:
Address:
576 Swan St, Richmond, Victoria, 3121.
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Country:
Australia
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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 St, Herston, Qld.
Country:
Australia
Date of approval:
6/12/2006
HREC Number:
2006/147
Ethics Committee name 2:
Q-Pharm Pty Ltd-Queensland Institute of Medical Research HREC
Address:
300C Herston Road Herston, Qld.
Country:
Australia
Date of approval:
13/10/2006
HREC Number:
H0610-047T (P1035)
Ethics Committee name 3:
Southern Health Human Research Ethics Committee
Address:
Monash Medical Centre 246 Clayton Road Clayton Victoria 3168
Country:
Australia
Date of approval:
1/09/2008
HREC Number:
08002A
Ethics Committee name 4:
Bellberry Human Research Ethics Committee
Address:
1st Floor, 71 Anzac Highway, Ashford, South Australia, 5035
Country:
Australia
Date of approval:
7/04/2008
HREC Number:
New ethics HREC. Please modify.
Countries of recruitment:
Australia
Brief summary:
This is a study of an experimental oral anti-cancer drug called CYT997, given every two weeks, to people with advanced cancer.
You may be eligible to join this study if you have an advanced solid tumour cancer and a life expectancy of more than three months.
CYT997 is an experimental anti-cancer agent which targets the blood supply to the tumour. Participants will receive CYT997 as an oral capsule dose on a two weekly cycle for up to six cycles.
Most advanced cancers will eventually stop responding to cancer treatments. In this situation, for people who may be eligible for this drug trial, there may not be any alternative standard treatments. Participants will receive supportive care and symptomatic treatments during the trial, in addition to receiving CYT997.
The major focus of this trial is to test the safety of CYT997 when given orally every 2 weeks. The trial also aims to assess the effect (good and bad) that CYT997 may have on you and your cancer. This involves finding out the highest dose of CYT997 that can be given without causing severe side effects.
This is a study of an experimental oral anti-cancer drug called CYT997, given every two weeks, to people with advanced cancer.
You may be eligible to join this study if you have any sort of solid cancer and a life expectancy of greater than three months.
Participants receive oral capsules of CYT997, which is an experimental anti-cancer agent which targets the blood supply to the cancer. This trial aims to determine the safety and tolerability of CYT997 when given as an oral capsule dose on a two weekly cycle for up to six cycles.
Most advanced cancers will eventually stop responding to cancer treatments. In this situation, there may not be an alternate standard treatment for people who may be suitable for this drug trial. Participants will receive supportive care and symptomatic treatments during the trial in addition to CYT997. This trial aims to find a maximum safe dose, and determine any side effects of CYT997 given orally every 2 weeks.
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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:
576 Swan St, Richmond, Victoria, 3121.
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Reason:
Country:
Australia
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Reason:
Tel:
+61 3 9208 4222
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Fax:
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Email:
gregg.smith@cytopia.com.au
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Reason:
Contact person for scientific queries
Name:
Dr Gregg Smith
Update:
Reason:
Address:
576 Swan St, Richmond, Victoria, 3121.
Update:
Reason:
Country:
Australia
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Reason:
Tel:
+61 3 9208 4222
Update:
Reason:
Fax:
+61 3 9208 4299
Update:
Reason:
Email:
gregg.smith@cytopia.com.au
Update:
Reason:
Contact person responsible for updating information
Name:
Dr Gregg Smith
Update:
Reason:
Address:
576 Swan St, Richmond, Victoria, 3121.
Update:
Reason:
Country:
Australia
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Reason:
Tel:
+61 3 9208 4222
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Reason:
Fax:
+61 3 9208 4299
Update:
Reason:
Email:
gregg.smith@cytopia.com.au
Update:
Reason:
