Safety Study of OXi4503 (a Vascular Disrupting Agent) Given by 3 x Weekly Intravenous Infusions to Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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The purpose of this study is to establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly infusions to patients with advanced solid tumors.

Official Title
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A Phase I Trial of OXi4503 (a Vascular Disrupting Agent) Given by 3 Weekly Intravenous Infusions to Patients With Advanced Solid Tumors.

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: OXi4503


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven cancer. Written informed consent. Age >/= 18 years. Life expectancy of at least 12 weeks. World Health Organization (WHO) performance status of 0 or 1. Adequate Hematological and biochemical indices to support investigational therapy. 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. Measurable and evaluable disease. All toxic manifestations of previous treatment must have resolved. Able to undergo MRI scanning. Exclusion Criteria: Radiotherapy, endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosureas and Mitomycin-C) prior to treatment. Pregnant and lactating women. Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered. Patients which have active uncontrolled infections. Patients with any other condition that in the Investigator's opinion would not make the patient a good candidate for the clinical trial. Patients known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV). Previous or ongoing cardiac conditions. Uncontrolled hypertension. Patients taking any drug known to prolong the QTc interval. Patients who have had any ischaemic or vascular damage from previous radiotherapy. Patients taking warfarin or heparin. Patients taking naproxen. Patients taking supplements or multivitamins containing vitamin C. Patients should not be taking any other investigational drug for the duration of the study. Patients with brain metastases or neurological tissue involvement of the spinal column.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OXi4503<br> | Drug: OXi4503<br>* OXi4503 will be administered weekly for 3 weeks followed by a week with no treatment. The starting dose will be 0.06 mg/m2 given as an intravenous infusion over 10 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503. |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, oxi4503, oxigene, cruk, solid tumors, VDA, vascular disrupting agent