Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000625673
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
11/10/2005
Date last updated
12/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I, open label study of extended dosing with PatrinTM in combination with temozolomide in the treatment of patients with advanced melanoma.
Scientific title
A Phase I, open label study of extended dosing with Patrin in combination with temozolomide in the treatment of patients with advanced melanoma. Part 1- to establish a dose for Part 2. Part 2 to test efficacy and safety of the dose established in Part 1.
Universal Trial Number (UTN)
Trial acronym
PAT/105
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced melanoma 753 0
Condition category
Condition code
Cancer 829 829 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patrin combined with temozolomide for 6 cycles.
Intervention code [1] 582 0
Treatment: Drugs
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 1060 0
Part 1 - to select a dose for further study based upon safety (dose limiting toxicties).
Timepoint [1] 1060 0
At day 28.
Primary outcome [2] 1061 0
Part 2 - to safety and efficacy based upon AE reports through out study and tumour measurements at Cycle 2.
Timepoint [2] 1061 0
Throughout study and at Cycle 2.
Secondary outcome [1] 1975 0
To determine the safety profile of the combination of PatrinTM administered orally for up to 14 days per cycle and TMZ administered orally for Day 1-5 of each cycle, repeated every 28 days and, to determine the qualitative and quantitative toxicity and reversibility of toxicity of the combination of PatrinTM with TMZ administered in this fashion.
Timepoint [1] 1975 0
Secondary outcome [2] 1976 0
To investigate the clinical pharmacodynamics of PatrinTM with TMZ when administered in this fashion.
Timepoint [2] 1976 0
Secondary outcome [3] 1977 0
To investigate anti-tumour activity of PatrinTM with TMZ when administered in this fashion.
Timepoint [3] 1977 0

Eligibility
Key inclusion criteria
Unresectable stage 3 /4 measurable (RECIST criteria), histologically proven cutaneous melanoma or unknown primary with melanoma metastases, without systemic treatment for metastatic disease.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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
Recruiting
Date of first participant enrolment
Anticipated
1/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 917 0
Commercial sector/Industry
Name [1] 917 0
Country [1] 917 0
Primary sponsor type
Commercial sector/Industry
Name
KuDOS Pharmaceuticals Limited
Address
Country
United Kingdom
Secondary sponsor category [1] 775 0
Commercial sector/Industry
Name [1] 775 0
ORION Clinical Services (Aust) Pty Ltd
Address [1] 775 0
Country [1] 775 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2203 0
Westmead Hospital
Ethics committee address [1] 2203 0
Ethics committee country [1] 2203 0
Australia
Date submitted for ethics approval [1] 2203 0
Approval date [1] 2203 0
Ethics approval number [1] 2203 0
Ethics committee name [2] 2204 0
Sydney Cancer Centre
Ethics committee address [2] 2204 0
Ethics committee country [2] 2204 0
Australia
Date submitted for ethics approval [2] 2204 0
Approval date [2] 2204 0
Ethics approval number [2] 2204 0
Ethics committee name [3] 2205 0
Ashford Cancer Centre
Ethics committee address [3] 2205 0
Ethics committee country [3] 2205 0
Australia
Date submitted for ethics approval [3] 2205 0
Approval date [3] 2205 0
Ethics approval number [3] 2205 0

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

Contacts
Principal investigator
Name 36237 0
Address 36237 0
Country 36237 0
Phone 36237 0
Fax 36237 0
Email 36237 0
Contact person for public queries
Name 9771 0
Yvonne Egan Davidson
Address 9771 0
ORION Clinical Services Australia Pty Ltd
Level 1
141 Osborne Street
South Yarra VIC 3141
Country 9771 0
Australia
Phone 9771 0
+61 3 98671064
Fax 9771 0
+61 3 98671086
Email 9771 0
yvonne.egandavidson@orioncro.com
Contact person for scientific queries
Name 699 0
Yvonne Egan Davidson
Address 699 0
ORION Clinical Services Australia Pty Ltd
Level 1
141 Osborne Street
South Yarra VIC 3141
Country 699 0
Australia
Phone 699 0
+61 3 98671064
Fax 699 0
+61 3 98671086
Email 699 0
yvonne.egandavidson@orioncro.com

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.