Back to resultsSafety Study of Increasing Doses of Combretasatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Hepatic Tumor Burden (OXi4503)
Primary Purpose
Neoplasm Metastasis
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Combretastatin A1 Diphosphate (OXi4503)
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm Metastasis focused on measuring hepatic tumor burden, liver cancer, liver carcinoma, carcinoma, hepatic cancer, hepatic carcinoma, VDA, Vascular Disrupting Agent
Eligibility Criteria
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.
Sites / Locations
- OXiGENE Investigational Site
- OXiGENE Investigational Site
- OXiGENE Investigational Site
- OXiGENE Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Combretastatin A1 Diphosphate
Arm Description
Outcomes
Primary Outcome Measures
To determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.
Secondary Outcome Measures
To determine progression-free survival (PFS).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00960557
Brief Title
Safety Study of Increasing Doses of Combretasatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Hepatic Tumor Burden
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mateon Therapeutics
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis
Keywords
hepatic tumor burden, liver cancer, liver carcinoma, carcinoma, hepatic cancer, hepatic carcinoma, VDA, Vascular Disrupting Agent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combretastatin A1 Diphosphate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Combretastatin A1 Diphosphate (OXi4503)
Intervention Description
OXi4503 administered IV on Days 1, 8, and 15 of each 28-day cycle.
Primary Outcome Measure Information:
Title
To determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
To determine progression-free survival (PFS).
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Brown, MD
Organizational Affiliation
Royal Adelaide Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Lickliter, MD
Organizational Affiliation
Monash Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Mainwaring, MD
Organizational Affiliation
Mater Adult Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Millward, MD
Organizational Affiliation
Sir Charles Gairdner Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
OXiGENE Investigational Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
OXiGENE Investigational Site
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
OXiGENE Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
OXiGENE Investigational Site
City
Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Increasing Doses of Combretasatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Hepatic Tumor Burden
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