Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000099527
Ethics application status
Approved
Date submitted
10/03/2006
Date registered
14/03/2006
Date last updated
14/03/2006
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 Renal Cell Carcinoma
Scientific title
An Open Label, Multi Centre, Phase II Study to Evaluate the Safety and Efficacy of Coramsine Injection in Patients with Renal Cell Carcinoma
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Renal Cell Carcinoma 1063 0
Condition category
Condition code
Cancer 1143 1143 0 0
Renal Cell Carcinoma

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] 937 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1537 0
Overall response rate
Timepoint [1] 1537 0
At 3 months
Secondary outcome [1] 2774 0
Safety
Timepoint [1] 2774 0
At 3 months
Secondary outcome [2] 2775 0
Progression free survival
Timepoint [2] 2775 0
At 15 months
Secondary outcome [3] 2776 0
Quality of life
Timepoint [3] 2776 0
At 3 months

Eligibility
Key inclusion criteria
1. Histologically confirmed diagnosis of non-resectable clear cell or papillary type Renal Cell Carcinoma. 2. Patients with bi-dimensionally measurable disease according to RECIST criteria on CT or MRI scanning. 3. Patients who are able and willing to provide written informed consent to participate in the study. 4. Patients with adequate haematological, hepatic and renal function. 5. ECOG performance status of 0-2. 6. Life expectancy of at least 16 weeks. 7. Must agree to the use of an adequate form of contraception. Negative pregnancy test in female patients of childbearing potential.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis with Sarcomatoid, Chromophobe, Collecting duct or Unclassified Renal Cell Carcinoma. 2. Patients with an active infection requiring oral or intravenous antibiotics. 3. Patients with significant cardiac or pulmonary disease or other significant medical condition which could impair the ability of the patient to participate. 4. Patients with recent (<6 months) peptic ulcerations or upper GI bleeding. 5. Pregnant or lactating women. 6. Patients with reactions to the Solanum species. 7. Active brain or other CNS metastases. 8. Unwilling or unable to have a venous access device. 9. Any other active malignancy. 10. Patients must not have had any radiotherapy for 3 weeks prior to entering the study and must be fully recovered from any acute effects. 11. Patients must not have had any prior chemotherapy for RCC (prior cytokines, vaccines, antiangiogenic agents or signal transduction agents are permitted). 12. Patients must not have had any other tumour treatment medications for 30 days prior to entering the study. 13. Patients must not be actively receiving any other investigational therapy, nor received any experimental agents within the previous 30 days. 14. 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)
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
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2006
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] 1248 0
Commercial sector/Industry
Name [1] 1248 0
Solbec Pharmaceuticals Ltd
Country [1] 1248 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Solbec Pharmaceuticals Ltd
Address
Country
Australia
Secondary sponsor category [1] 1103 0
None
Name [1] 1103 0
N/A
Address [1] 1103 0
Country [1] 1103 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35245 0
Address 35245 0
Country 35245 0
Phone 35245 0
Fax 35245 0
Email 35245 0
Contact person for public queries
Name 10126 0
Robyn Ferguson
Address 10126 0
Solbec Pharmaceuticals Ltd
1/298 Selby Street
Osborne Park WA 6017
Country 10126 0
Australia
Phone 10126 0
+61 8 94467555
Fax 10126 0
+61 8 94468777
Email 10126 0
robyn.ferguson@solbec.com.au
Contact person for scientific queries
Name 1054 0
Stephen Carter
Address 1054 0
Solbec Pharmaceuticals Ltd
1/298 Selby Street
Osborne Park WA 6017
Country 1054 0
Australia
Phone 1054 0
+61 8 94467555
Fax 1054 0
+61 8 94468777
Email 1054 0
sjcarter@iprimus.com.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.