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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.

Phase 1
18 Years
Not Enrolling
Solid Tumors

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Trial Information

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

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

- 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.

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

- Patients with brain metastases or neurological tissue involvement of the spinal

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions.

Outcome Time Frame:

4 weeks

Safety Issue:



United Kingdom: Department of Health

Study ID:




Start Date:

July 2005

Completion Date:

Related Keywords:

  • Solid Tumors
  • Phase 1
  • oxi4503
  • oxigene
  • cruk
  • solid tumors
  • VDA
  • vascular disrupting agent
  • Neoplasms