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Trial registered on ANZCTR


Registration number
ACTRN12606000078550
Ethics application status
Approved
Date submitted
15/02/2006
Date registered
23/02/2006
Date last updated
23/02/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Albendazole (oral) phase I
Scientific title
A phase I (dose escalation) study of oral albendazole in patients with cancer refractory to conventional treatments to determine optimal dosing in cancer patients
Secondary ID [1] 244 0
TGA and St George Ethics Committee: ALB1
Universal Trial Number (UTN)
Trial acronym
Albendazole
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer refractory to conventional treatments 1042 0
Condition category
Condition code
Cancer 1119 1119 0 0
Biliary tree (gall bladder and bile duct)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An inter-patient dose escalation of oral albendazole according to the following schema:

-1. 400mg daily, day 1 - 7 every 28 days
1. 400mg twice daily, day 1 - 7 every 28 days
2. 400mg twice daily, day 1 - 14 every 28 days
3. 400mg 3 times per day, day 1 - 14 every 28 days
4. 800mg twice daily, day 1 - 14 every 28 days
5. 800mg twice daily, day 1 - 14 every 21 days
6. 1200mg morning 800mg afternoon, day 1 - 14 every 21 days
7. 1200mg twice daily, day 1 - 14 every 21 days

Dose will be increased if no dose limiting toxicity occurs. If one occurs, the cohort will be will be expanded to 6. If it recurs the dose limiting toxicity has been identified and no further dose increase will occur.
Intervention code [1] 896 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1496 0
To determine the maximum tolerated dose. No further dose increase will occur once the maximum tolerated dose is determined.
Timepoint [1] 1496 0
The maximum tolerated dose will be defined as being one dose level below that at which a dose limiting toxicity appeared in 33% of a single cohort.
Secondary outcome [1] 2692 0
1. To determine pharmacokinetics and safety profile.
Timepoint [1] 2692 0
Pharmacokinetics are measured during cycle 1. Safety is monitored through weekly visits to clinic where adverse events are identified.
Secondary outcome [2] 2693 0
2. To determine preliminary efficacy through weekly measurement of relevant tumour markers.
Timepoint [2] 2693 0

Eligibility
Key inclusion criteria
1. Histologically or cytologically proven advanced or metastatic cancer2. Patients must have measurable (by imaging studies such as CT but not bone scan) or evaluable disease 3. Refractory to conventional treatments 4. A maximum of two previous systemic myelosuppressive chemotherapy regimens.5. Eastern Co-operative Oncology Group score (ECOG) 0-3 performance status.6. Patients with previously treated CNS (central nervous system) metastases are eligible, provided there is no clinical or radiological evidence of on-going CNS disease progression.7. Patients must have recovered from the reversible side effects of prior therapy.8. At least 3 weeks since prior chemotherapy (at least 6 weeks for agents known to be toxic to stem cells such as nitrosoureas, melphalan, or mitomycin).9. At least 2 weeks since any prior radiotherapy. No more than 25% of bone marrow may have been irradiated in the past.10. Patients of all races and ethnic backgrounds are eligible.11. Adequate Haematological function12. Absolute neutrophils > 1,500/mm3, platelets > 100,000/mm3, 13. bilirubin < 2x upper limit normal 14. Alanine amino transferase/aspartate amino transferase < 10 x upper limit of normal, 15. Calculated creatinine clearance > 60 mls/min.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with unresolved ongoing infection requiring treatment.2. Decompensated liver disease with non malignant ascites or coagulopathy or encephalopathy3. Severe comorbidity at the discretion of the investigators4. Pregnancy or breast feeding mothers.

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
3 patients per dose cohort, expanded to 6 if dose limiting toxicity (DLT) occurs
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1224 0
Charities/Societies/Foundations
Name [1] 1224 0
Liver Foundation
Address [1] 1224 0
Country [1] 1224 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital
Address
Country
Australia
Secondary sponsor category [1] 1081 0
None
Name [1] 1081 0
nil
Address [1] 1081 0
Country [1] 1081 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2554 0
St George Hospital
Ethics committee address [1] 2554 0
Kogarah
Ethics committee country [1] 2554 0
Australia
Date submitted for ethics approval [1] 2554 0
Approval date [1] 2554 0
31/07/2001
Ethics approval number [1] 2554 0
ver 1.5
Ethics committee name [2] 2555 0
St George Private Hospital
Ethics committee address [2] 2555 0
Kogarah
Ethics committee country [2] 2555 0
Australia
Date submitted for ethics approval [2] 2555 0
Approval date [2] 2555 0
31/07/2001
Ethics approval number [2] 2555 0
ver 1.5

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

Contacts
Principal investigator
Name 35443 0
Address 35443 0
Country 35443 0
Phone 35443 0
Fax 35443 0
Email 35443 0
Contact person for public queries
Name 10085 0
Michael Szwajcer
Address 10085 0
Clinical Trials Unit
Cancer Care Centre
St George Hospital
Kogarah NSW 2217
Country 10085 0
Australia
Phone 10085 0
+61 2 93503461
Fax 10085 0
+61 2 93502960
Email 10085 0
michael.szwajcer@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 1013 0
Dr Matthew Links
Address 1013 0
Clinical Trials Unit
Cancer Care Centre
St George Hospital
Kogarah NSW 2217
Country 1013 0
Australia
Phone 1013 0
+61 2 93501935
Fax 1013 0
+61 2 93502960
Email 1013 0
matthew.links@sesiahs.health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary