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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00977210

Enrollment

Registered

2009-09-15

Start date

2005-07-31

Completion date

Unknown

Last updated

2011-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Keywords

Phase 1, oxi4503, oxigene, cruk, solid tumors, VDA, vascular disrupting agent

Brief 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.

Interventions

DRUGOXi4503

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions.	4 weeks

Secondary

Measure	Time frame
To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503.	4 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026