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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00960557




Registration number
NCT00960557
Ethics application status
Date submitted
14/08/2009
Date registered
17/08/2009
Date last updated
22/08/2011

Titles & IDs
Public title
Safety Study of Increasing Doses of Combretasatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Hepatic Tumor Burden
Scientific title
A Multicenter, Open-label Phase 1b/2 Study to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Primary or Secondary Hepatic Tumor Burden
Secondary ID [1] 0 0
OXC101-100
Universal Trial Number (UTN)
Trial acronym
OXi4503
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasm Metastasis 0 0
Neoplasm Metastasis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Combretastatin A1 Diphosphate (OXi4503)
Treatment: Drugs - Combretastatin A1 Diphosphate (OXi4503)

Experimental: Combretastatin A1 Diphosphate -

Experimental: Combretastatin A1 Diphosphate -


Treatment: Drugs: Combretastatin A1 Diphosphate (OXi4503)
OXi4503 administered IV on Days 1, 8, and 15 of each 28-day cycle.

Treatment: Drugs: Combretastatin A1 Diphosphate (OXi4503)
OXi4503 administered IV on Days 1, 8, and 15 of each 28-day cycle.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.
Timepoint [1] 0 0
6 Months
Primary outcome [2] 0 0
To determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.
Timepoint [2] 0 0
6 Months
Secondary outcome [1] 0 0
To determine progression-free survival (PFS).
Timepoint [1] 0 0
6 Months
Secondary outcome [2] 0 0
To determine progression-free survival (PFS).
Timepoint [2] 0 0
6 Months

Eligibility
Key inclusion criteria
1. Histologically or cytologically confirmed carcinoma. Tumor must be relapsed or
refractory to standard therapies, or have no acceptable standard therapy.

2. Measurable disease by RECIST criteria.

3. Subjects must be at least 28 days from other investigational therapy and at least 2
weeks after chemotherapy or radiation therapy.

4. Age 18 years or older.

5. Eastern Cooperative Oncology Group (ECOG) Performance Score of less than 1.

6. Life expectancy of greater than 12 weeks.

7. Hemoglobin greater than 10 g/dL.

8. Adequate hepatic function.

9. Adequate renal function.

10. Adequate bone marrow reserve.

11. Able to maintain potassium, calcium and magnesium levels within normal ranges.

12. Must be able to provide written informed consent.

13. All women of childbearing potential (WOCBP) must have a negative serum pregnancy test.

14. WOCBP and fertile men and their partners must agree to use an effective form of
contraception during the study and for 90 days after the last dose of study
medication.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Uncontrolled CNS metastases.

2. No other active malignancies.

3. Poorly controlled hypertension.

4. Recent history of serious cardiovascular conditions.

5. Recent history of CVA, TIA, or intermittent claudication.

6. Current anticoagulation therapy.

7. History of cardiac arrhythmias.

8. Abnormal ECG findings.

9. Subjects who require concomitant medications which cause QTc prolongation.

10. Major surgery within 30 days of treatment, or minor surgery within 7 days of
treatment.

11. Uncontrolled, clinically significant active infection.

12. Subjects who are pregnant or lactating.

13. Subjects with any other intercurrent medical condition.

14. Subjects with a history of solid organ transplant or bone marrow transplant.

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)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
OXiGENE Investigational Site - Westmead
Recruitment hospital [2] 0 0
OXiGENE Investigational Site - South Brisbane
Recruitment hospital [3] 0 0
OXiGENE Investigational Site - Adelaide
Recruitment hospital [4] 0 0
OXiGENE Investigational Site - Bentleigh
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3165 - Bentleigh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mateon Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the safety and tolerability of OXi4503 in subjects
with relapsed or refractory carcinomas with hepatic tumor burden.
Trial website
https://clinicaltrials.gov/show/NCT00960557
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Brown, MD
Address 0 0
Royal Adelaide Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications