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Trial registered on ANZCTR


Registration number
ACTRN12609000652279
Ethics application status
Approved
Date submitted
16/07/2009
Date registered
3/08/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and tolerability of the Traditional Chinese Medicine Formulation "GOPAC" in patients with advanced malignancy
Scientific title
Phase I study of the Safety and Tolerability of the Traditional Chinese Medicine formulation "GOPAC" in patients with advanced malignancy
Secondary ID [1] 280414 0
None
Universal Trial Number (UTN)
Trial acronym
GOPAC trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced malignancy (palliative) 237270 0
Condition category
Condition code
Cancer 239592 239592 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"GOPAC" is a traditional chinese herbal medicine proprietary formulation consisting of 5 herbs in a capsule formulation.
It is administered as a combination of 2 oral capsules:
1. "Clone of Concord Sunchih GOPAC" (Ganoderma lucidum 140mg spore & 100mg extract; Agrimonia eupatoria 75mg; Patrinia scabiosaefolia 75mg; Hedyotis diffusa 100mg; Cordyceps sinensis 10mg)
2. "Concord Vita-cordy"
(Cordyceps sinensis 400mg)

Duration of supplement: 6 wks
Mode Of Administration (MOA): oral capsule

Dose (dose escalation study):
1. Cohort 1: 2 capsules each three times a day (TDS)
2. Cohort 2: 3 capsules each TDS
3. Cohort 3: 4 capsules each TDS
Intervention code [1] 236950 0
Treatment: Drugs
Comparator / control treatment
No comparator.

3 treatment groups as it is a dose escalation study.
As above (for 6 wks):

1. Cohort 1: 2 capsules each TDS
2. Cohort 2: 3 capsules each TDS
3. Cohort 3: 4 capsules each TDS
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238382 0
Phase I: safety, as measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE V4.0)
Timepoint [1] 238382 0
Phase I: weekly measurements of adverse events (by NCI CTCAE V4.0) and bloods
for 6 weeks of active therapy; then fortnightly for another 4 weeks
Secondary outcome [1] 244833 0
Phase I:
* patient tolerance (as measured by pill count, physician assessment)
* maximum tolerated dose (measured by dose limiting toxicity)
Timepoint [1] 244833 0
Phase I: end of 6 weeks of active therapy

Eligibility
Key inclusion criteria
* Active malignancy (recurrent or metastatic)
* can swallow capsules WHOLE
* Fluent english or chinese
* not currently receiving chemotherapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inadequate organ function
Allergy to study ingredients (esp. mushrooms)
Eastern Cooperative Oncology performance group (ECOG PS) > 3
Concurrent radiotherapy
Major comorbidities

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)
Eligible patients for Phase I will be enrolled, and systematically allocated into treatment groups. No blinding for phase I trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Dose escalation study
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 237340 0
Self funded/Unfunded
Name [1] 237340 0
Country [1] 237340 0
Primary sponsor type
Hospital
Name
Sydney South West Area Health Service
Address
Sydney Cancer Centre,
Building 76
Concord Repatriation General Hospital
Hospital Road
Concord West 2139 NSW
Country
Australia
Secondary sponsor category [1] 236827 0
None
Name [1] 236827 0
Address [1] 236827 0
Country [1] 236827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239458 0
Human Research & Ethics Committee - Concord
Ethics committee address [1] 239458 0
Ethics committee country [1] 239458 0
Australia
Date submitted for ethics approval [1] 239458 0
18/03/2009
Approval date [1] 239458 0
22/06/2009
Ethics approval number [1] 239458 0
09/CRGH/47

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

Contacts
Principal investigator
Name 29909 0
Address 29909 0
Country 29909 0
Phone 29909 0
Fax 29909 0
Email 29909 0
Contact person for public queries
Name 13156 0
Dr. Inger Olesen
Address 13156 0
Sydney Cancer Centre,
B76, Concord Repatriation General Hospital
Hospital Road
Concord West 2139 NSW
Country 13156 0
Australia
Phone 13156 0
+61 2 9767 6354
Fax 13156 0
+61 2 9767 5764
Email 13156 0
iolesen@med.usyd.edu.au
Contact person for scientific queries
Name 4084 0
Professor Stephen Clarke
Address 4084 0
Sydney Cancer Centre,
B76, Concord Repatriation General Hospital
Hospital Road
Concord West 2139 NSW
Country 4084 0
Australia
Phone 4084 0
+61 2 9767 6775
Fax 4084 0
+61 2 9767 7603
Email 4084 0
sclarke@med.usyd.edu.au

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.