Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000330549
Ethics application status
Approved
Date submitted
24/07/2006
Date registered
3/08/2006
Date last updated
3/08/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open Label, Multi Centre, Phase II Study to Evaluate the Safety and Efficacy of Coramsine Injection in Patients with Melanoma
Scientific title
An Open Label, Multi Centre, Phase II Study to Evaluate the Safety and Efficacy of Coramsine Injection in Patients with Melanoma
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Melanoma 1299 0
Condition category
Condition code
Cancer 1390 1390 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coramsine Injection. 1.5mg/kg infused over 4 hours, daily for 5 days. Six cycles.
Intervention code [1] 1222 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1893 0
Overall response rate
Timepoint [1] 1893 0
At 3 months
Secondary outcome [1] 3346 0
Safety
Timepoint [1] 3346 0
At 3 months
Secondary outcome [2] 3347 0
Progression free survival
Timepoint [2] 3347 0
At 15 months
Secondary outcome [3] 3348 0
Quality of Life
Timepoint [3] 3348 0
At 3 months.

Eligibility
Key inclusion criteria
1. Histologically confirmed diagnosis of stage IV or unresectable stage III Melanoma 2. Patients with bi-dimensionally measurable disease according to RECIST criteria 3. Patients who are able and willing to provide written informed consent to participate in the study. 4. Patients must have adequate haematological, hepatic and renal function 5. ECOG Performance status of 0-2. 6. Life expectancy of at least 16 weeks. 7. Fertile males and females must agree to the use of an adequate form of contraception. Negative pregnancy test is required in female patients of child-bearing potential.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with an active infection requiring oral or intravenous antibiotics 2. Patients with significant cardiac or pulmonary disease or evidence of any other significant medical condition, which in the opinion of the principal investigator could impair the ability of the patient to participate in the trial. 3. Patients with recent (< 6 months) peptic ulcerations or upper GI bleeding. 4. Pregnant or lactating women. 5. Reactions to the Solanum species (potatoes, tomatoes, aubergines and capsicum). 6. History of adverse reactions to related compounds. 7. Active brain or other CNS metastases. Stable/controlled brain metastases are permitted following treatment with surgery or radiation therapy. A minimum of 4 weeks must have elapsed since surgical or radiation treatment of brain metastases. 8. Unwilling/unable to have a venous access device inserted. 9. Known seropositive to HIV, Hepatitis B or Hepatitis C 10. Any other active malignancy 11. Patients must not have had any radiotherapy for 3 weeks prior to entering the study, and must be fully recovered from the acute effects of any prior radiotherapy. 12. Patients must not have greater than 2 previous regimens of chemotherapy treatment for Melanoma. Prior treatment with cytokines, vaccines, antiangiogenic agents or signal transduction inhibitors is permitted. 13. Patients must not have had any other tumour treatment medications for 30 days prior to entering the study. 14. Patients must not be actively receiving any other investigational therapy, nor received any experimental agents within the previous 30 days. 15. Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.

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)
Nil
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
Nil
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1523 0
Commercial sector/Industry
Name [1] 1523 0
Solbec Pharmaceuticals Ltd
Country [1] 1523 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Solbec Pharmaceuticals Ltd
Address
Country
Australia
Secondary sponsor category [1] 1338 0
None
Name [1] 1338 0
N/A
Address [1] 1338 0
Country [1] 1338 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Melanoma is the least common but the most life-threatening of all skin cancers, accounting for only about 4% of all cases but causing 79% of skin cancer deaths.
Whilst early stage melanoma can be successfully treated by surgical removal, few
effective treatments exist for melanoma which has progressed to a later stage.

The purpose of this study is to investigate the effect of Coramsine® in patients with late stage melanoma as well as evaluate the safety and tolerability of the drug.
Also, the effect of Coramsine on Progression Free Survival will be assessed (this is defined as the length of time during and after treatment that the cancer does not grow and includes the amount of time patients have experienced a complete response or a partial response, as well as the amount of time patients have experienced stable disease).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35776 0
Address 35776 0
Country 35776 0
Phone 35776 0
Fax 35776 0
Email 35776 0
Contact person for public queries
Name 10411 0
Robyn Ferguson
Address 10411 0
Solbec Pharmaceuticals Ltd
1/298 Selby Street
Osborne Park WA 6017
Country 10411 0
Australia
Phone 10411 0
+61 8 9446 7555
Fax 10411 0
+61 8 9446 8777
Email 10411 0
[email protected]
Contact person for scientific queries
Name 1339 0
Graeme Howie
Address 1339 0
Solbec Pharmaceuticals Ltd
1/298 Selby Street
Osborne Park WA 6017
Country 1339 0
Australia
Phone 1339 0
+61 8 9446 7555
Fax 1339 0
+61 8 9446 8777
Email 1339 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.