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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977210
• Other study ID #: PH1/098
• Status: Completed
• Phase: Phase 1
• First received: September 14, 2009
• Last updated: October 28, 2011
• Start date: July 2005

Study information

• Verified date: October 2011
• Source: OXiGENE
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• OXi4503
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.

Locations

Country	Name	City	State
United Kingdom	CRUK Investigational Site	Manchester
United Kingdom	CRUK Investigational Site	Middlesex

Sponsors (2)

Lead Sponsor	Collaborator
OXiGENE	Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly intravenous infusions.		4 weeks	Yes
Secondary	To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) behavior of OXi4503.		4 weeks	Yes

External Links

•   CRUK Study Posting