Clinical trial NCT00960557: Safety Study of Increasing Doses of Combretasatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Hepatic Tumor Burden
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm Metastasis
Keywords: hepatic tumor burden
liver cancer
liver carcinoma
carcinoma
hepatic cancer
hepatic carcinoma
VDA
Vascular Disrupting Agent
Lead sponsor: Mateon Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-08-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: To determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.
timeFrame: 6 Months
Secondary outcomes:
measure: To determine progression-free survival (PFS).
timeFrame: 6 Months
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: OXiGENE Investigational Site
state: New South Wales
city: South Brisbane
country: Australia
facility: OXiGENE Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: OXiGENE Investigational Site
state: South Australia
city: Bentleigh
country: Australia
facility: OXiGENE Investigational Site
state: Victoria
Study officials:
affiliation: Royal Adelaide Hospital
name: Michael Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash Medical Centre
name: Jason Lickliter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mater Adult Hospital
name: Paul Mainwaring, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Charles Gairdner Hospital
name: Michael Millward, MD
role: PRINCIPAL_INVESTIGATOR
References: