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

Sponsor

Mateon Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00960557

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Metastasis	Drug: Combretastatin A1 Diphosphate (OXi4503)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Combretastatin A1 Diphosphate

Drug: Combretastatin A1 Diphosphate (OXi4503)

OXi4503 administered IV on Days 1, 8, and 15 of each 28-day cycle.

Outcome Measures

Primary Outcome Measures

To determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden. [6 Months]

Secondary Outcome Measures

To determine progression-free survival (PFS). [6 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically or cytologically confirmed carcinoma. Tumor must be relapsed or refractory to standard therapies, or have no acceptable standard therapy.
Measurable disease by RECIST criteria.
Subjects must be at least 28 days from other investigational therapy and at least 2 weeks after chemotherapy or radiation therapy.
Age 18 years or older.
Eastern Cooperative Oncology Group (ECOG) Performance Score of less than 1.
Life expectancy of greater than 12 weeks.
Hemoglobin greater than 10 g/dL.
Adequate hepatic function.
Adequate renal function.
Adequate bone marrow reserve.
Able to maintain potassium, calcium and magnesium levels within normal ranges.
Must be able to provide written informed consent.
All women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
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:

Uncontrolled CNS metastases.
No other active malignancies.
Poorly controlled hypertension.
Recent history of serious cardiovascular conditions.
Recent history of CVA, TIA, or intermittent claudication.
Current anticoagulation therapy.
History of cardiac arrhythmias.
Abnormal ECG findings.
Subjects who require concomitant medications which cause QTc prolongation.
Major surgery within 30 days of treatment, or minor surgery within 7 days of treatment.
Uncontrolled, clinically significant active infection.
Subjects who are pregnant or lactating.
Subjects with any other intercurrent medical condition.
Subjects with a history of solid organ transplant or bone marrow transplant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OXiGENE Investigational Site	Westmead	New South Wales	Australia	2145
2	OXiGENE Investigational Site	South Brisbane	Queensland	Australia	4101
3	OXiGENE Investigational Site	Adelaide	South Australia	Australia	5000
4	OXiGENE Investigational Site	Bentleigh	Victoria	Australia	3165