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Trial registered on ANZCTR


Registration number
ACTRN12609000253202
Ethics application status
Approved
Date submitted
18/02/2009
Date registered
13/05/2009
Date last updated
12/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Multicenter, Open-Label Phase 1b/2 Study to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503, CA1P) as Monotherapy in Subjects with Primary or Secondary Hepatic Tumour Burden
Scientific title
A Multicenter, Open-Label Phase 1b/2 Study to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503, CA1P) when treated on Days 1, 8 and 15 of a 28 day treatment cycle in escalating doses as Monotherapy in Subjects with Primary or Secondary Hepatic Tumour Burden until the maximum tolerated dose is determined.
Secondary ID [1] 811 0
Protocol number: OXC101-100
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinomas with Primary (Hepatocellular carcinoma) or Secondary Hepatic Tumour (carcinoma metastasis) Burden 4354 0
Condition category
Condition code
Cancer 4599 4599 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be dosed in 28-day treatment cycles by IV infusion of Combretastatin A1 Diphosphate (OXi4503, CA1P). Subject will have up to 6 cycles of treatment. Dosing will commence at 8.5 mg/m2 and escalate to 11.0, 13.5 and 15.5 mg/m2 and then increase by an additional 25% of the preceding dose level thereafter.
Intervention code [1] 4175 0
Treatment: Drugs
Comparator / control treatment
Not applicable, study is Dose Comparision
Control group
Dose comparison

Outcomes
Primary outcome [1] 5475 0
Primary Outcome 1: To determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden. The assessments will include collection of adverse events [as per Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0], laboratory (blood)tests and physical examination.
Timepoint [1] 5475 0
At each clinic visit through-out the study
Primary outcome [2] 5476 0
Primary Outcome 2: To determine the maximum tolerated dose of OXi4503, which will be the dose used in the phase 2 part of the study. The assessments will include collection of adverse events [as per Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0], laboratory (blood) tests and physical examination.
Timepoint [2] 5476 0
At each clinic visit through-out the study
Primary outcome [3] 5565 0
Primary Outcome 3: To determine the Pharmacokinetic (PK) profile for OXi4503 and its major metabolites in subjects with hepatic tumor burden. The assessment will be by analysis of blood concentration levels.
Timepoint [3] 5565 0
At each clinic visit through-out the study
Secondary outcome [1] 9217 0
To determine progression-free survival (PFS)
Timepoint [1] 9217 0
At each clinic visit through-out the study
Secondary outcome [2] 9218 0
To determine the proportion (%) of subjects with stable disease (SD),
Timepoint [2] 9218 0
At each clinic visit through-out the study

Eligibility
Key inclusion criteria
1.Signed Informed Consent Form. 2.Histologically or cytologically confirmed carcinoma, including carcinoid. All subjects in phases 1b and 2 must have hepatic tumor burden; primary hepatocellular carcinoma (HCC), or secondary metastatic deposits. 3. Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) criteria a. Each subject must have a measurable hepatic lesion. b. Non-HCC subjects must have nonirradiated, measurable disease in the liver and an extrahepatic site. 4. Tumor must be relapsed or refractory to standard therapies, or have no acceptable standard therapy.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Uncontrolled Central Nervous System (CNS) metastases. 2. Prior treatment with a Vascular Disrupting Agent (VDA). 3. Subjects with history of prior malignancy except for curatively treated basal cell carcinoma of the skin; cervical intraepithelial neoplasia; or localized prostate cancer with a current prostate-specific antigen (PSA) < 4.0 mg/dL. Subjects with other curatively treated malignancies who have no evidence of metastatic disease and > 2-year disease-free interval may be entered after approval by the Medical Monitor. 4. Uncontrolled Hypertension (HTN), defined as Blood Pressure (BP) > 120/80 mm Hg, despite medication.

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 / Phase 2
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] 4537 0
Commercial sector/Industry
Name [1] 4537 0
OXiGENE, Inc.
Address [1] 4537 0
230 Third Avenue, 6th Floor
Waltham , MA 02451
Country [1] 4537 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Network Services (CNS) Pty Ltd
Address
Level 3, 88 Jephson Street
Toowong, Brisbane QLD 4066
Country
Australia
Secondary sponsor category [1] 4093 0
Commercial sector/Industry
Name [1] 4093 0
OXiGENE, Inc
Address [1] 4093 0
230 Third Avenue, 6th Floor
Waltham, MA 02451
Country [1] 4093 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6586 0
Ethics committee address [1] 6586 0
Ethics committee country [1] 6586 0
Date submitted for ethics approval [1] 6586 0
21/01/2009
Approval date [1] 6586 0
Ethics approval number [1] 6586 0

Summary
Brief summary
to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503, CA1P)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29306 0
Address 29306 0
Country 29306 0
Phone 29306 0
Fax 29306 0
Email 29306 0
Contact person for public queries
Name 12553 0
CNS Project Manager
Address 12553 0
Level 4, 88 Jephson Street Toowong, Brisbane QLD 4066
Country 12553 0
Australia
Phone 12553 0
+61 7 3331 3933
Fax 12553 0
+61 7 3870 0520
Email 12553 0
cns@clinical.net.au
Contact person for scientific queries
Name 3481 0
CNS Project Manager
Address 3481 0
Level 4, 88 Jephson Street Toowong, Brisbane QLD 4066
Country 3481 0
Australia
Phone 3481 0
+61 7 3331 3933
Fax 3481 0
+61 7 3870 0520
Email 3481 0
cns@clinical.net.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