Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000078459
Ethics application status
Approved
Date submitted
10/01/2007
Date registered
23/01/2007
Date last updated
14/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase Ia study of MRC202 in patients with malignant ascites caused by cancer.
Scientific title
A phase Ia (pharmacokinetic) study of intraperitoneal MRC202 in patients with peritoneal cancer refractory to standard treatments.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant ascites (hydoperitoneum) associated with cancer 1570 0
Condition category
Condition code
Cancer 1671 1671 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an open label study of patients with malignant ascites. The patients will initially have ascites drained. A 1L dose (varying concetrations of either 800mg/L, 1600mg/L or 2000mg/L) of MRC202 will be administered, immediately following drainage, via an intraperitoneal catheter. Patients will remain under observation for 4 weeks, after which a wash-out product will be administered. Blood and peritoneal fluid will be sampled regularly (1, 2, 4, 6, 8, 24, 48, 96 hours and at the 4 week timepoint).
Intervention code [1] 1547 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2313 0
Determine pharmakokinetics of MRC202 and sulfoxide metabolites
Timepoint [1] 2313 0
Sampling timepoints at 1, 2, 4, 6, 8, 24, 48 and 96 hours and 4 weeks after intraperitoneal administration.
Primary outcome [2] 2314 0
Determine dose response to ensure it is within safety limits, as defined by Guidance on Good Clinical Practice (CPMP/ICH/135/95).
Timepoint [2] 2314 0
At 4 weeks over limited range of exposures
Secondary outcome [1] 4039 0
Determine feasibility of intraperitoneal adminstration for MRC202.
Timepoint [1] 4039 0
End of Phase Ia trial
Secondary outcome [2] 4040 0
Determine feasibility of : Vascular Endothelial Groth Factor (VEGF); circulating endothelial cells; and Vascular Cell Adhesion Molecule - 1 (VCAM) expression in blood and peritoneal fluid as markers of inhibition of angiogensis.
Timepoint [2] 4040 0
At sampling timepoints of 1, 2, 4, 6, 8, 24, 48 and 96 hours and 4 weeks after intraperitoneal administration.

Eligibility
Key inclusion criteria
Histologically or cytologically proven advanced or metastatic cancer.Positive or suggestive peritoneal cytology.Judged likely to benefit from insertion of peritoneal port for symptom control.Must have measurable or evaluable disease.Ascites refractory to standard treatments.ECOG 0-3 performance status.At least 3 weeks since prior chemotherapy (at least 6 weeks from agents know to be toxic to stem cells)Must have recovered from reversible side effects of prior therapy.At least 2 weeks since any prior radiotherapy.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unresolved ongoing infection requiring treatment.Decompensated liver disease with non-malignant ascites or coagulopathy or encephalopathy.Severe co-morbidity at the discretion of the investigatorsUnwilling or unable to have insertion of an intraperitoneal portacath.Pregnant 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
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
10/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1816 0
Commercial sector/Industry
Name [1] 1816 0
MRC Biotech Pty Ltd
Country [1] 1816 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
MRC Biotech Pty Ltd
Address
Level 17, 201 Miller St
North Sydney, NSW, 2060
Country
Australia
Secondary sponsor category [1] 1638 0
None
Name [1] 1638 0
NA
Address [1] 1638 0
Country [1] 1638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3405 0
St. George Hospital
Ethics committee address [1] 3405 0
Ethics committee country [1] 3405 0
Australia
Date submitted for ethics approval [1] 3405 0
Approval date [1] 3405 0
17/01/2007
Ethics approval number [1] 3405 0
06/62

Summary
Brief summary
The study is aimed at evaluating the suitablility of MRC202 as a therapy for malignant ascites associated with cancer. based on extensive animal studies MRC202 has been shown as potential an effective agent to slow or treat malignant ascites. This initial study is aimed as determining an appropriate dose concentration. Data from the study will be used to design a more comprehensive study assessing the efficacy of the drug.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27481 0
Address 27481 0
Country 27481 0
Phone 27481 0
Fax 27481 0
Email 27481 0
Contact person for public queries
Name 10736 0
David Andrews
Address 10736 0
MRC Biotech Pty Ltd
Level 17
201 Miller St
North Sydney NSW 2060
Country 10736 0
Australia
Phone 10736 0
+61 2 89232561
Fax 10736 0
Email 10736 0
[email protected]
Contact person for scientific queries
Name 1664 0
David Andrews
Address 1664 0
MRC Biotech Pty Ltd
Level 17
201 Miller St
North Sydney NSW 2060
Country 1664 0
Australia
Phone 1664 0
+61 2 89232561
Fax 1664 0
Email 1664 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
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Documents added automatically
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