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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mateon Therapeutics
• Collaborator: Cancer Research UK

Criteria

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.