Safety Study of Increasing Doses of Combretasatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Hepatic Tumor Burden

Neoplasm Metastasis Clinical Trial

— OXi4503  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960557
• Other study ID #: OXC101-100
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2009
• Last updated: August 22, 2011
• Start date: July 2009
• Est. completion date: October 2010

Study information

• Verified date: August 2011
• Source: OXiGENE
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics CommitteeAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Neoplasms
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
Australia	OXiGENE Investigational Site	Adelaide	South Australia
Australia	OXiGENE Investigational Site	Bentleigh	Victoria
Australia	OXiGENE Investigational Site	South Brisbane	Queensland
Australia	OXiGENE Investigational Site	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
OXiGENE

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.		6 Months	Yes
Secondary	To determine progression-free survival (PFS).		6 Months	Yes

External Links

•   Sponsor Website