A Phase I Trial of OXi4503 (a Vascular Disrupting Agent) Given by 3 Weekly Intravenous Infusions to Patients With Advanced Solid Tumors.
- 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
- 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
- Measurable and evaluable disease.
- All toxic manifestations of previous treatment must have resolved.
- Able to undergo MRI scanning.
- 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
- Patients with brain metastases or neurological tissue involvement of the spinal