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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasm Metastasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combretastatin A1 Diphosphate

Group Type EXPERIMENTAL

Combretastatin A1 Diphosphate (OXi4503)

Intervention Type DRUG

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

Interventions

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Combretastatin A1 Diphosphate (OXi4503)

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No